Investigational Ultra-Long-Acting Insulin Degludec Reduces Hypoglycemia and Improves Long-Term Control in Patients With Type 1 and Type 2 Diabetes

SAN DIEGO, June 27, 2011 /PRNewswire/ -- Ultra-long acting insulin degludec, under development by Novo Nordisk, lowers blood glucose levels with significantly reduced rates of hypoglycemia (low blood sugar) compared to insulin glargine, according to data presented at the 71st Scientific Sessions of the American Diabetes Association (ADA) in San Diego. Data were from two, phase three, 52-week clinical trials, one with individuals with type 1 and one in individuals with type 2 diabetes.

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Separately, in a late-breaking presentation, data revealed that insulin degludec could be dosed at different times from day to day in a 26-week trial.

"Episodes of low blood sugar, known as hypoglycemia, are a major concern for many people with diabetes," said Alan Garber, MD, Professor, Departments of Medicine, Baylor College of Medicine, in Houston, Texas, USA.  "It is particularly encouraging that insulin degludec significantly reduces the rate of overall hypoglycemia in type 2 patients and nocturnal hypoglycemia, in patients with type 1 or type 2 diabetes. The findings of these studies suggest that insulin degludec potentially offers substantial benefits for patients and the management of their diabetes."

Findings include:

  • The 52-week studies were designed to reach similar glycemic targets for all patients (known as treat-to-target) and at one year patients taking insulin degludec experienced *HbA1C reductions of 0.4% in patients with type 1 diabetes and 1.2% for patients with type 2 diabetes, which was statistically non-inferior to insulin glargine.
  • In type 2 patients, a significantly lower rate of hypoglycemic events with insulin degludec compared to those given insulin glargine (11.1 vs. 13.6 episodes/patient-yr; p=0.0359).
  • Rates of nocturnal hypoglycemia, classified as occurring between midnight and 5:59 am, were 25% lower in both the type 1 and type 2 diabetes patients taking insulin degludec than those taking insulin glargine (4.4 vs. 5.9 episodes/patient-yr, p = 0.021; and 1.4 vs. 1.8 episodes/patient-yr, p=0.0399, respectively).

Also during ADA, data was presented showing possibility to dose degludec at different times from day to day in patients with type 2 diabetes. The study demonstrated that changes in the injection time of insulin degludec from day to day (up to 40 hours apart) did not affect overall glycemic control or risk of hypoglycemia when compared to insulin glargine.

Insulin degludec was dosed once-daily by alternating morning and evening injections from day to day, while insulin glargine was administered at the same time each day, according to its prescribing instructions.  Insulin degludec and insulin glargine reduced HbA1C by 1.28 and 1.26% points, respectively.

The trials were "treat-to-target" studies, meaning insulin was titrated systematically to achieve a target fasting glucose level. Patients in both of the open label trials, using insulin degludec and insulin glargine had similar starting glucose levels, allowing researchers to closely determine the differences between the treatments.

*HbA1C is the calculation used to measure blood glucose levels over a period of time.

Additional details about the insulin degludec studies presented at the 71st Scientific Sessions of the American Diabetes Association (ADA)

NN1250-3582 (Type 2), 74-OR:

  • Name: A 52-week treat-to-target trial comparing efficacy and safety of insulin degludec and glargine both administered OD in a basal–bolus regimen with insulin aspart plus or minus metformin plus or minus pioglitazone in patients with type 2 diabetes mellitus previously treated with insulin (BEGIN™: BB)
  • The study included 992 patients from 12 countries using basal-bolus therapy consisting of ultra-long-acting insulin degludec or insulin glargine, plus rapid-acting insulin aspart at mealtime
  • Patients had comparable HbA1C reductions of 1.2% to a final HbA1C of 7.1%, meeting the non-inferiority primary endpoint
  • Fasting plasma glucose (FPG) was reduced by 43 mg/dl with insulin degludec and 38 mg/dl with insulin glargine (Estimated Treatment Difference (ETD) IDeg - IGlar: −5.2 mg/dl [95% CI: −11.7; 1.1], p=NS)
  • Patients taking insulin degludec had 18% reduction in overall hypoglycemia and 25% reduction of nocturnal hypoglycemia compared to those treated with insulin glargine
  • Mean total daily insulin doses at one year were 1.46 U/kg for the insulin degludec group and 1.42 U/kg for the insulin glargine group, with an ~50:50 basal/bolus split in both groups

NN1250-3583 (Type 1), 70-OR:

  • Name: A 52-week treat-to-target trial comparing efficacy and safety of insulin degludec and insulin glargine both administered OD in a basal–bolus regimen with insulin aspart as mealtime insulin in patients with type 1 diabetes mellitus (BEGIN™: BB T1 LONG)
  • The study included 629 patients from 6 countries using basal-bolus therapy consisting of ultra-long-acting insulin degludec or insulin glargine, plus rapid-acting insulin aspart at mealtime
  • Patients in the trial had an HbA1C reduction of around 0.4 % to a final HbA1C of 7.3% in both insulin degludec and insulin glargine treatment arms, meeting the non-inferiority primary endpoint  
  • Patients taking insulin degludec and patients taking insulin glargine had similar rates of overall confirmed hypoglycemia. However, patients taking insulin degludec had a 25% lower rate of nocturnal confirmed hypoglycemia than those treated with insulin glargine [95% CI: 0.59;0.96], p=0.021
  • Mean FPG was reduced by 23 mg/dl and 25 mg/dl for insulin degludec and insulin glargine, respectively (ETD: -5.9 mg/dl [95% CI: -18.6; 6.5], p=NS)
  • Mean total daily insulin doses at one year were 0.75 U/kg for the insulin degludec group, and 9% higher at 0.82 U/kg for the insulin glargine group, with an ~50:50 split of basal/bolus doses in both groups

In both studies, insulin degludec effectively improved HbA1C and was non-inferior to insulin glargine in basal-bolus therapy in type 1 and type 2 diabetes. The most common adverse events occurring in more than 5% of patients in both studies included influenza, nasopharyngitis, upper respiratory tract infection, arthralgia, back pain, pain in extremity, headaches, diarrhea, peripheral edema, wrong drug administered, cough and hypertension across all treatment arms.

NN1250-3668 (Type 2), 35-LB:

  • Name: Flexible once-daily dosing of insulin degludec does not compromise glycemic control or safety compared to insulin glargine given once-daily at the same time each day in people with type 2 diabetes (BEGIN™ Flex)
  • The 26-week study included 687 patients from 14 countries using ultra-long-acting insulin degludec or insulin glargine
  • Mean FPG was significantly lower for insulin degludec than insulin glargine (104 vs. 112 mg/dl)
  • Mean daily basal insulin dose after 26 weeks were 0.6 U/kg for the insulin degludec group and 0.5 U/kg for the insulin glargine group for insulin-naïve patients and 0.6 U/kg for the insulin degludec and insulin glargine groups for prior insulin users

There were no serious adverse events in more than 5% of patients in any of the treatment arms.

Headquartered in Denmark, Novo Nordisk is a global healthcare company with 88 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. For more information, visit novonordisk.com .

©2011 Novo Nordisk  0511-00003174-1  June 2011

SOURCE Novo Nordisk

CONTACT: Media: Outside North America: Katrine Rud von Sperling, +45-4442-6718, krsp@novonordisk.com; In North America: Ambre Morley, +1-609-987-5898, abmo@novonordisk.com; Investors: Outside North America: Klaus Bulow Davidsen, +45-4442-3176, klda@novonordisk.com; Jannick Lindegaard, +45-4442-4765, jlis@novonordisk.com; Frank Daniel Mersebach, +45-4442-0604, fdni@novonordisk.com

Web Site: http://www.novonordisk.com

Posted: June 2011

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