Investigational ultra-long-acting insulin degludec reduces hypoglycaemia and improves long-term control

Tuesday, 28 June 2011

Ultra-long-acting insulin degludec, under development by Novo Nordisk, lowers blood glucose levels with significantly reduced rates of hypoglycaemia (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.(1,2)

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.(3)

"Episodes of low blood sugar, known as hypoglycaemia, 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 hypoglycaemia in type 2 patients and nocturnal hypoglycaemia, 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 glycaemic 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.(1,2)
In type 2 patients, a significantly lower rate of hypoglycaemic events with insulin degludec compared to those given insulin glargine (11.1 vs. 13.6 episodes/patient-yr; p=0.0359)(1)
Rates of nocturnal hypoglycaemia, 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).(1,2)

Also during ADA, data were presented showing possibility to dose insulin 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 glycaemic control or risk of hypoglycaemia 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.(3) Insulin degludec and insulin glargine reduced HbA1C by 1.28 and 1.26 percentage points, respectively.

The trials were 'treat-to-target' studies, meaning insulin was titrated systematically to achieve a target fasting glucose level. Patients in 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.(4)

1. Garber A. Insulin degludec improves long-term glycaemic control with less nocturnal hypoglycaemia compared with insulin glargine: 1-year results from randomized basal-bolus trial in people with type 2 diabetes. Abstract presented at the 71st Scientific Sessions of the American Diabetes Association, 26 June 2011. (NN1250-3582)
2. Heller S. Insulin degludec improves long-term glycaemic control with less nocturnal hypoglycaemia compared with insulin glargine: 1-year results from randomized basal-bolus trial in people with type 1 diabetes. Abstract presented at the 71st Scientific Sessions of the American Diabetes Association, 26 June 2011. (NN1250-3583)
3. Meneghini L. 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. Abstract presented at the 71st Scientific Sessions of the American Diabetes Association, 26 June 2011. (NN1250-3668)
4. Guidance for Industry Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention; U.S. Department of Health and Human Services; Food and Drug Administration; Center for Drug Evaluation and Research (CDER); February 2008 Clinical/Medical = DRAFT GUIDANCE http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071625.pdf