New Ultra-Long-Acting Insulin Taken Thrice a Week Will Reduce Pain of Daily Jabs

A thrice-a-week insulin shot instead of the once-a-day shot at present could soon be a reality.

Doctors from India, Canada, US and South Africa have jointly tested the most promising new form of long- acting insulin ‒ degludec ‒  needed once every 48 hours, and found it to be as good in controlling blood sugar as the presently used insulin of choice, glargine  (e.g. Lantus), which is a 24-hour shot.

This means that once in the market, the number of injections needed by a type-2 diabetic patient would be cut by half every week. It will also make insulin shots cheaper for patients. Pharma giant Novo Nordisk of Denmark, which funded the study, hopes to apply for licensing approval to market the drug in 2013.

However, the findings still need to be confirmed in another phase of research, and it’s not clear how much the drug would cost if it were approved for this use. The Phase 2 trial results were published this week in the medical journal The Lancet.

Nonetheless, the findings are promising because most patients with diabetes don’t want to have injections at all, if they can help it. And those who have to take them would prefer less. Moreover, each additional injection per day is a financial burden.

Announcing the results of their 16-week, phase-II trial of degludec in the medical journal Lancet, scientists said, “In this 16-week randomized trial, participants aged 18-75 years with type-2 diabetes and glycosylated hemoglobin (HbA1C) of 7-11% were enrolled and treated at 28 clinical sites in Canada, India, South Africa and US. At study end, mean HbA1c levels were much the same across treatment groups and insulin degludec provided comparable glycemic control to insulin glargine without additional adverse events. This might reduce dosing frequency due to its ultra-long action profile.”

The novel insulin releases over several days appears as effective as once-daily standard insulin in type 2 diabetes, an open-label trial found. HbA1c levels reached a similar 7.2% to 7.5% over 16 weeks whether patients got the novel insulin degludec three times a week or once daily, or standard insulin glargine (e.g. Lantus) once daily, Bernard Zinman, MD, of Mount Sinai Hospital at the University of Toronto, and colleagues reported online in The Lancet.

Adverse events, including hypoglycemia, were likewise comparable across the insulin groups in the phase II study, mirroring what Zinman initially presented at the American Diabetes Association meeting last summer.

“Insulin degludec is an ultra-long-acting insulin in clinical development. Its features suggest that the risk of hypoglycemia might be reduced and clinical effectiveness might be achievable with dosing three times a week in people with type-2 diabetes who were previously insulin-naive which could help with early initiation of and adherence to insulin treatment,” the study says.

“It’s an exciting new insulin, it’s an ultra-long-acting insulin and the real issue is, of course, this is a small study, a proof-of-concept study, and we have to wait for the results of much larger studies to know where its place will be in a clinical setting,” Zinman said in an interview. “It just has a much longer half-life, much more than 24 hours, compared to the other insulin and may provide some additional advantage.”

However, Zinman said he doesn’t see that three-times-per-week injections will be a common way to treat diabetes. “When you inject three times a week, the doses have to be increased so that it covers the full week, and in those circumstances, the benefits with respect to reducing the rates of hypoglycemia are not there,” he said.

“Personally, I wouldn’t use it that way. I would use it as once-daily insulin,” said Zinman, but he thinks if people do forget to take their insulin on occasion, this would be more forgiving. “We find people do occasionally forget their insulin, so this may — because it has a longer half-life and hangs around longer — that may be an advantage. I think we need to do studies to really see if that’s the case.”

However, topline results from a more recent phase III study comparing insulin degludec to insulin glargine  again showed virtually identical glycemic control without a significant difference in hypoglycemia between groups.

While it had been hoped that the ultra-long-acting formulation might actually reduce hypoglycemia episodes, the chance to cut down on dosing frequency would be a valuable feature for clinical practice even without a safety or efficacy advantage over current basal insulin choices, Zinman’s group suggested.

“A three-times-a-week, weekend-off, dosing regimen might appeal to some people with type 2 diabetes who are inadequately controlled on oral anti-diabetic drug treatments, potentially helping with acceptance and early initiation of insulin therapy,” they wrote in the paper.

A longer dosing interval could be important in boosting adherence as well, and with less disruption to patients’ lifestyle, Yogish C. Kudva, MBBS, and Ananda Basu, MBBS, both of the Mayo Clinic in Rochester, Minn., noted in an accompanying commentary.

But regardless of increasing numbers of long-acting options in diabetes treatment, lifestyle changes can’t be overlooked, they urged.

“It is extremely worthwhile to remember that therapeutic lifestyle changes are inexpensive and favorable on a risk–benefit basis and need persistent re-emphasis, as is being done for the financial benefits accruing to patients from their employer and insurance by doing so,” Kudva and Basu wrote in the commentary.

The proof-of-concept study by Zinman’s group randomized 245 insulin-naive patients with inadequately controlled type 2 diabetes to open-label treatment at 28 centers internationally with one of the following regimens in combination with metformin:

• Insulin degludec three times a week ‒ Monday, Wednesday, and Friday evenings — with a starting dose of 20 U per injection

• Insulin degludec in a 600 nmol/mL formulation once a day, with a starting dose of 10 U per injection

• Insulin degludec in a 900 nmol/mL formulation once a day, also at a starting dose of 10 U per injection

• Insulin glargine once a day, at a starting dose of 10 U per injection

Mean reductions in HbA1c over 16 weeks of treatment hit 1.3% to 1.5% in all the groups without significant differences among them. Nor were fasting plasma glucose concentrations any different between groups by the end of the study.

Confirmed hypoglycemia episodes of glucose falling below 55.8 mg/dL or requiring assistance occurred among 23% of patients on thrice-weekly insulin degludec or insulin glargine  but 8% to 15% of those on once-daily insulin degludec. Although the difference between the highest and lowest rates was significant, the researchers noted that the 95% confidence intervals overlapped among all the between-group comparisons.

Nocturnal hypoglycemia by the same measure was uncommon, at 0% to 5% across groups, which the researchers attributed in part to the short duration of diabetes in the cohort.

However, as was pointed out at the ADA presentation of the data, the 55.8 mg/dL threshold may have missed hypoglycemia cases by the more standard 70 mg/dL criteria.

Diabetes specialist Dr. Vivian Fonseca, who chairs the endocrinology section at Tulane University Health Sciences Center, cautioned that more research is needed to determine if people who take the drug will face a higher risk of low blood sugar.

That’s a major problem for people who currently take insulin medications, she said, as is the unpredictability of the drugs. “You give the same dose to the same person every day, and the next morning you get a different result,” Fonseca said. “That is challenging for patients.”

The researchers also reported that body weight remained stable throughout the trial for all treatment groups, and they pointed to “no apparent treatment-specific patterns or clustering of adverse events.”

However, they cautioned about drawing firm conclusions on safety or efficacy based on the phase II data and noted that the open-label design used because of the different insulin-injection systems for the drugs might have impacted efforts to get glucose under control, as well as reporting of hypoglycemia and adverse events.

Dr Anoop Misra, chairman of Fortis Hospital’s Centre of Excellence for Diabetes in New Delhi, India, said, “This is quite a breakthrough. For the first time, we have a ultra-long acting insulin with stable action. This will lead to lesser injections (once in two days) for the patients with good blood sugar control…Till now, all long acting insulin shots are for 24 hours.”

It typically takes years for a drug to go through research and get approval from the U.S. government. The three-times-a-week degludec needs just one more phase of research, however, meaning that it could be on the market fairly soon if it’s found to be effective. There’s no indication of how much it would cost, although Kudva said it’s fair to assume that it will be more expensive than insulin is today.

But one thing remains clear, Kudva said: “The most effective treatment for diabetes, a treatment that is worth doing throughout life, is attention to diet and exercise and working on one’s weight. These are difficult to achieve, but even as every new medication comes, there’s no getting away from that.”

The study was sponsored by the drug maker Novo Nordisk of Denmark, and three of the paper’s authors are employees of the company and own stock. Zinman, who helped design the study and obtain and interpret the data, has received fees for consultancy and honoraria for membership of advisory boards from Novo Nordisk and a number of other drug companies.

Diabetes: Is the ADA Shifting its Stance About Carbs?

Carbohydrates are a very touchy subject with diabetics. And for me at least, understanding carbs in a diabetic diet is more difficult than quantum mechanics (or double-entry accounting if you’re not a science type). Diabetologists and dieticians, too, have differing views. I found this article by LAURA DOLSON very instructive and am reproducing it here for those who may have missed it. You can find the lively discussion that followed the article’s publication here.

You may be surprised to know that for the past couple of decades, the American Diabetes Association has been sort of a cheerleader for carbs. Yes, I’m talking about the organization who’s mission it is to promote education and research in ways aimed at preventing diabetes and alleviating the suffering of diabetics.

What is diabetes? It is essentially a disorder of the body’s ability to process carbohydrates. This includes Type 1 and Type 2 diabetes, pre-diabetes, metabolic syndrome, insulin resistance, and all the other points on the diabetes spectrum. (The Endocrine Society suggests that anyone with a fasting blood glucose of 89 or above is at risk for damage to their health.)

In light of this, you’d think that limiting carbohydrate intake would be a priority in educating people about handling these disorders. And yet, the ADA jumped right onto the Food Pyramid bandwagon and began to advise people to get at least 55% of their calories from carbohydrate, such as in the Food Pyramid for Diabetes (see illustration above).

In 2008, they made one exception: diabetics trying to lose weight could follow a low-carb diet for up to one year; this was later loosened further to two years. But still they did not recommend a low-carb diet for health, blood sugar control, or preventing progression of the diabetes.

Now, in the March 2011 edition of the ADA magazine “Diabetes Forecast” are three rather remarkable articles. The first is called The “ADA Diet” Myth, which claims that there is no such thing as the ADA Diet! (Who else was having this hallucination?) Instead, Stephanie Duncare, director of nutrition and medical affairs for the ADA says, “For more than 15 years now, ADA has recognized that people with diabetes should eat in a way that helps them reach their blood glucose, cholesterol, blood pressure, and weight goals. For some, this means a relatively higher-carbohydrate diet, and for others, the diet may be lower in carbohydrate”. Well, hallelujah to that, especially if the goal is “normal blood glucose” (normal meaning “a blood glucose level that will not cause further damage in the pancreas”).

Even more bold is an article called, “Are Carbs the Enemy?” which attempts to cover the debate. They first present a sort of wimpy pro-carb stance. This section of the article has a notable absence of anything to do with science, instead relying on statements such as “Gone are the days of ‘diabetic diets’ that were meager and confining” and “as long as people eat less or cover their carb intake with medications, they can keep blood glucose levels in check with a healthy diet” (“healthy” in this case meaning “high-carb”).

The article then goes on to describe a low-carb approach, citing Dr. Richard Bernstein. This section cites actual evidence, and makes what I think is a much stronger case for controlling blood glucose by limiting carbohydrates. The article goes on to a section on saturated fats which is much more balanced than usual, and then the normal “we don’t have the long-term studies”. The article concludes with the statement: “In the end, the best diet is the healthy one you’re able to follow.”

The only thing I would add is that people need support in making those changes, and as far as I can tell they are still leaving an awful lot up to the individual to figure it out for themselves. There has been quite a defeatist attitude coming from the organization that is supposed to be helpful – along the lines that it is asking just too much of people to cut carbs in any significant way. Are dietitians now actually going to support people in finding a diet that achieves as close to a normal blood glucose as possible? It would be a very big change if this happened any time soon.

But wait, there’s more! A follow-on short piece called “Eating With Diabetes: 3 Approaches” lists the low-carb approach first, and then follows with “Moderate-Carb” and “Vegan/High-Carb”. The weird thing is that the three approaches are described as “less than 10% carb”, “40-50% carb” and “75% carb”. What about people who normalize their blood glucose with 20% carb or 30% carb? Why not just say, “it’s a spectrum disease, with a spectrum of carb that will treat it effectively”? In any case, I don’t want to complain too loudly, because this is SO great to see in an ADA publication!

Now, to be sure, the ADA is not yet changing their basic stance. Nowhere on the latest update of the diabetes.org Web site is it stated that diabetics should follow a low-carb diet. On the other hand, there is no longer anything I can find that says to eat over half of calories from carbohydrate, either. The former food pyramid, as far as I can tell, has vanished, and there are several hints that low-carb eating is becoming a bona-fide option.

There are statements such as, “Understanding the effect of carbohydrate on blood glucose levels is key to managing diabetes. The carbohydrate in food makes blood glucose levels go up.” Although diabetics are still advised that “a place to start is at about 45-60 grams of carbohydrate at a meal.”, (yikes) it goes on to say to adjust from there. Even though this is not what most of us would call a low-carb diet, for most people it is a reduction from their previous advice.

[Side note: I also notice it doesn’t actually say 45-60 g/meal is a good place to start. If that actually controls someone’s blood glucose, that’s great, but I would think that in the cases where it doesn’t, it would be more disheartening to subsequently take more carb away. Why not start lower, and then add? Also, most likely, the person for whom this works is losing weight – a phase which doesn’t last forever.]

To me this looks like the beginnings of a real change in approach from the ADA. The Titantic may actually be turning around! This could make a difference to the health of millions of people, and nothing could make me smile more than that.

By Laura Dolson/about.com

Image courtesy about.com

Self-Monitoring Blood Sugar: Is ‘Second Drop’ and Squeezing Finger to Draw Blood OK?

I’ve been regularly testing my blood sugar at home for nearly a decade now. At times when I get an error message on the glucometer (thanks to incorrect technique but more often because of insufficient blood), I never hesitate to squeeze out a second drop of blood on a fresh strip to get a “proper” reading. All the while I was blissfully unaware that both my actions are a matter of debate in Diabetes Self-Management Education (DSME) pundits.

It seems there is no general agreement regarding the use of the first or second drop of blood for glucose monitoring. The American Diabetes Association and other groups say that people should thoroughly wash and dry their hands, and then test the first drop of blood that comes from the finger. However, they do not have advice on what to do when you cannot wash your hands.

Now a new study suggests if soap and water are nowhere to be found, using the “second drop” of blood may be OK.

As for squeezing the finger, the researchers found that too much pressure did appear to interfere with accurate test results. On average, blood sugar readings were lower when people put pressure on the finger. The finding, according to the researchers, is in line with advice to avoid firm squeezing of the tested finger.

For the study, Dutch researchers at the Isala Clinics Diabetes Center at Zwolle in the Netherlands had 123 people with diabetes test their blood sugar under various conditions: after thoroughly washing and drying their hands; without hand washing; after handling fruit, which leaves sugar on the fingers; and after washing their fruity fingers.

The participants also tested their blood sugar using varying amounts of pressure to squeeze a drop of blood from the tested finger. (In general, guidelines advise against squeezing the finger too hard to get a blood drop because it may distort blood sugar readings.)

Overall, the study found, clean hands and the first drop provide the most accurate result. But compared with tests of clean hands, 11 percent of study participants had test results that were at least 10 percent off when they tested the first drop of blood from their unwashed hands. The same was true of 4 percent of study participants when they used the second drop of blood.

Based on that, the researchers recommend that people wash and dry their hands before testing, then use the first blood drop. But if they cannot wash up for some reason, it’s “acceptable” to use the second drop after wiping away the first.

But what about fruity hands? In that case ‒ or whenever hands are visibly dirty ‒ a good washing is necessary, according to the researchers. They found that when study participants tested fruit-exposed hands without washing, 88 percent had blood sugar levels that were at least 10 percent off from their clean-hand readings ‒ at least when using the first drop of blood.

They fared better when using the second drop. But 11 percent still had results that differed substantially from their clean-hand measurements.

As for squeezing the finger, the researchers found anywhere from 5 to 13 percent of study participants had a significantly different blood sugar result (versus no squeezing), depending on how much pressure they put on the finger. On average, blood sugar readings were lower when people put pressure on the finger. The finding, according to the researchers, is in line with advice to avoid firm squeezing of the tested finger.

The findings are published in the early online edition of the journal Diabetes Care.

SOURCE: Diabetes Care

Promoting Self-Management is Essential to Properly Treat Type 2 Diabetes

One of the most important aspects of diabetes management is educating the patient to manage their condition themselves. This is known as Diabetes Self-Management Education, better known by its acronym DSME. It has been demonstrated by many studies that education works.

DSME is defined as the ongoing process of facilitating the knowledge, skill and ability necessary for effective self-management and is guided by evidence-based standards. Patients with diabetes who do not receive DSME are found to be four times more likely to develop a major complication of diabetes and incur higher diabetes-related hospital costs.

I support the concept of DSME, given the fact that many family doctors do not have enough knowledge to effectively advise diabetes patients (see my earlier post ‘Why most doctors are clueless about treating diabetes’) and visits to a specialist involve long waiting periods and longer commutes.

In this interesting interview conducted by Endocrine Today, Linda Siminerio, RN, PhD, CDE, director of the University of Pittsburgh Diabetes Institute, and associate professor at the University of Pittsburgh School of Medicine and the School of Nursing answers many questions regarding DSME.

How can physicians effectively educate patients who currently have type 2 diabetes?

I think it is always helpful when physicians have access to additional resources to support team-based care. For example, referral to dietitians and diabetes education programs can be a powerful adjunct for comprehensive, quality care given the limited time they have available to spend with their patients. I have been involved in many studies and national surveys on referral practices, and we found that physicians often do not refer patients to these programs.

How can physicians effectively educate patients who are at risk for developing type 2 diabetes?

It is important for physicians to know what lifestyle intervention resources that address weight reduction and physical activity are available in their communities so that they can refer patients appropriately. Local YMCAs that offer lifestyle programs can be a valuable resource for physicians and patients. For example, in Indiana, some YMCAs have adapted the Diabetes Prevention Program (DPP) into a 16-week diabetes reduction program in the community setting. In Pittsburgh, the Diabetes Prevention Resource Center offers a 12–week Group Lifestyle Balance (GLB) program adapted from the DPP that is offered at community sites and in primary care practices. Physicians and practice staff should explore their respective communities to find community-friendly resources for their patients at risk for chronic disease.

What are your recommendations for creating collaboration between physicians and educators?

Physicians can refer their patients to the American Diabetes Association Web site to learn about community-based, recognized self-management education programs. Additionally, the American Association of Diabetes Educators Web site provides a variety of education materials that can be downloaded.

Even if patients obtain referrals from their physicians to participate in a program, they may not attend. I recommend that educators be integrated in the practice so that the educator becomes a part of the practice team. Educators and physicians should work together. Other support mechanisms are available in communities, but they are not always used. Primary care physicians should work with others in the community, such as local pharmacists, to effectively educate patients.

How can physicians promote diabetes self-management?

Diabetes self-management education (DSME) should always be considered as part of the treatment plan, even if a patient is reported to have excellent metabolic control. Attention to self-care behaviors and psychosocial needs are equally as important as metabolic outcomes when managing a burdensome, chronic disease like diabetes. Active listening, providing accurate information and building a patient’s confidence are all important tools used in diabetes education. It is essential that physicians and everyone on the diabetes care team work together to support patient self-management by developing patient-centered goals that will be more likely to be achieved.

How do you determine the best treatment option for patients?

Every patient and situation is individual. Thus, it is important for everyone on the diabetes care team to take time to listen to the patient’s needs and desires. The physician, along with the team, should provide patients with the necessary information to build a realistic care plan. Patients need to be informed so they can make informed decisions about their own care.

Do patients who have received this sort of patient-centered care have better results in the long run versus patients who may not receive ongoing support?

Research shows that diabetes self-management is an important component of diabetes care and has an impressive effect on HbA1c levels. In a meta-analysis, diabetes education was reported to reduce HbA1c by 0.76%. Since a 1% decrease in HbA1c is associated with a dramatic reduction in myocardial infarctions, micro-vascular disease and death, a 0.76% reduction can be considered an enormous benefit. Further, duration of contact time between a patient and an educator is the only significant predictor of the DSME effect. This suggests that DSME alone is not sufficient to maintain improved behaviors and that sustained improvements require contact and follow up.

We also know that if education is not sustained or supported, then HbA1c levels go back up. So, we need to continue to explore opportunities for continued support. Community-based programs, like wellness programs, YMCAs, churches and senior centers are potential forums for community friendly self-management support systems.

 

Hospitalized Diabetics Should Have Higher Than Normal Sugar Levels

After hospitalization for hernia surgery two months ago, my blood sugar levels, which had been reasonably good before I went under the knife, suddenly went haywire. Readings of 200+ mg/dl were common for a couple of days after surgery. My doctors said they were looking at a target of around 180 mg/dl, which they said was optimal. Still, I was unhappy that my A1c levels were compromised.

So it was with interest that I read the new guidelines released by the American College of Physicians recommending that doctors not attempt intensive insulin therapy designed to achieve normal blood sugar levels in patients in medical or surgical intensive care units. These guidelines are for both people with diabetes and without the condition.

The college recommends that doctors should maintain blood sugar levels between 140 and 200 milligrams per deciliter (mg/dl) for anyone in medical or surgical intensive care.

These recommendations ‒ published in the February 15 issue of Annals of Internal Medicine ‒ are similar to the guidelines from the American Diabetes Association (ADA) and the American Association of Clinical Endocrinologists (AACE). However, those guidelines recommend that blood sugar levels should be kept below 180 mg/dl to reduce the risk of infection and other complications.

For reference, in a healthy person with type 2 diabetes, normal blood sugar levels would be between 70 mg/dl and 130 mg/dl before eating. And, even after eating (postprandial), the recommendation from the ADA is to keep blood sugar levels under 180 mg/dl.

Talking to Serena Gordon of Health.com Dr. Amir Qaseem, director of clinical policy in the medical education division of the American College of Physicians explained, “[High blood sugar] is a common finding in hospitalized patients, and it’s associated with a lot of complications, like delayed healing, increased infection, cardiovascular events, you name it. The prevailing thought in the past was that tightly controlling the blood sugar levels would reduce inflammation, clotting and other problems. But, there are also harms that are associated with lowering the blood glucose levels too much. [Low blood sugar] can be very dangerous.”

“The evidence isn’t clear on what range of blood sugar is best, but 140 to 200 mg/dl seems to minimize the risk of hypoglycemia [in surgical or medical units],” said Qaseem. “We felt it was better to stick with a range that is a little bit higher.”

The American Association of Clinical Endocrinologists (AACE) and the American Diabetes Association (ADA) have also published updated guidelines for treating high blood glucose while avoiding low blood glucose in hospitalized patients.

The main objectives of the 2009 AACE/ADA recommendations were to identify reasonable, achievable, and safe glycemic targets and to describe the protocols, procedures, and system improvements needed to facilitate their implementation. For most patients a blood glucose target of 140-180 mg/dl is recommended and appropriate use of insulin is the preferred approach for achieving safe, optimal glucose control.

“Hyperglycemia in hospitalized patients is common and associated with increased risk of infection, mortality, and increased cost,” said AACE President Daniel Einhorn, MD, FACP, FACE. “Although near normalization of glucose in these patients appears to be of no greater benefit than moderate glycemic targets, ignoring hyperglycemia in this population is no longer acceptable.”

There is substantial observational evidence linking hyperglycemia in hospitalized patients (with or without diabetes) to poor outcomes. Although initial small studies suggested that intensive glycemic control (insulin infusion with goal blood glucose targets of 80-110 mg/dl) improved outcomes in surgical  ICU and medical ICU patients, subsequent trials have failed to show a benefit or have even shown increased mortality of intensive targets compared to more moderate targets (140-180 mg/dl). Moreover, these recent studies have highlighted the risk of severe hypoglycemia resulting from attempts to completely normalize blood glucose.

“Both over treatment and under treatment of hyperglycemia in hospitalized patients are patient safety issues,” said Robert R. Henry, MD, President, Medicine and Science for the American Diabetes Association. “Coordinated, interdisciplinary teams have been shown to achieve both safe and effective control of hyperglycemia in hospitalized patients.”

The recent ACP guidelines are for the most part consistent with the AACE/ADA recommendations.  AACE/ADA maintains that the upper limit of 180 mg/dl is safe and justified by data on benefits of glycemic control and the harms of uncontrolled hyperglycemia. Practitioners should take heart in the commonality of recommendations among all the organizations to address hospital hyperglycemia in the safest manner.

Dr. Mary Korytowski, a professor of medicine at the University of Pittsburgh School of Medicine, and a member of the board of directors of the American Diabetes Association, concurs that intensive insulin management in medical and surgical units isn’t the best way to manage blood sugar any more.  “(But) 200 mg/dl is probably too high. The 2009 ADA/AACE guidelines recommend 180 mg/dl, which is consistent with postprandial numbers in diabetes care. The problem is that if you set the target too high, those numbers may be even higher when someone starts giving insulin to bring those numbers down,” she explains.

“These guidelines should not be interpreted to mean that glucose control isn’t important for critically ill patients: It is. And it’s important not to let the blood sugar get too high because of the risk of complications, like a higher risk of infection and fluid and electrolyte abnormalities,” she says, adding that it’s important to remember these guidelines give a range of options. “Managing blood sugar closer to the lower end is probably better,” she concludes.

Also see how illness can affect blood sugar levels in people with diabetes from the American Diabetes Association.

Diabetes Drug Trials: Roche Halts Taspoglutide Dosing in Final Studies

Roche Holding has stopped giving patients its experimental diabetes treatment taspoglutide in late stage clinical trials due to a high rate of adverse reactions, marking a major blow to drug once seen to have $2 billion a year potential.

The Swiss drugmaker said on Friday that the decision was based on a higher-than-expected rate of discontinuations due to gastrointestinal (GI) intolerability, and due to serious hypersensitivity reactions experienced by some patients, according to 52-week data from the trials.

“These discontinuation rates compromise interpretation of the long term safety data from the T-emerge studies, therefore continuing treatment with the current taspoglutide formulation is not considered to be in the best interest of patients,” Roche said in a statement.

Leerink Swann analyst Joshua Schimmer said in a research note that if Phase III dosing has been suspended “we believe that this is the final blow for what was perceived as a compound in trouble after the disappointing data on hypersensitivity and nausea/vomiting presented at the American Diabetes Association (meeting) this year.”

The drug, given once weekly by injection, suffered a serious setback in June, when it was reported that there were cases of patients suffering hypersensitivity reactions to the medicine in clinical trials.

The latest blow to Roche is seen as a boon to Amylin Pharmaceuticals Inc  and Eli Lilly and Co, which are awaiting a US approval decision for their once-weekly injectable diabetes drug Bydureon.

Roche said it was not abandoning its drug, but was considering a reformulation of the medicine. Any reformulation would likely cause a significant delay beyond the one Roche signaled in June when the hypersensitivity data was revealed at the diabetes meeting.

At that time Roche said the setback would likely cause a delay in filing for approval of a minimum of 12 to 18 months. It had previously been aiming to apply for taspoglutide approval worldwide in 2011.

“Roche is assessing approaches to identify the root cause of the serious hypersensitivity reactions and to optimize the taspoglutide formulation to improve GI tolerability,” Roche spokesman Terrence Hurley said.

“Upon review of options available, Roche will communicate about the next steps of the overall taspoglutide program by year end,” he added.

Roche said out of 3,000 patients there were 23 cases of serious hypersensitivity reaction, and that all the patients recovered without complications.

While the percentage is low, as with the GI problems the number was higher than expected, Roche said.

The most frequently reported symptoms in patients who developed hypersensitivity reactions were skin reactions, nausea, and vomiting, while cardiovascular and respiratory symptoms were less frequent, Roche said.

Roche, which licensed taspoglutide from France-based Ipsen, once had high hopes for for the drug. It had said in the past that taspoglutide could garner peak sales of at least 2 billion Swiss francs ($1.77 billion).

However analysts had already sharply lowered their sales projections for the drug following the previous clinical setbacks.

“Amylin’s Bydureon is expected to be the only weekly GLP-1 in the near-term,” said ISI Group analyst Mark Schoenebaum in a research note, referring the class of drugs to which the Amylin/Lilly and Roche drugs belong.

Bill Berkrot/Reuters