Main Newsletter
Mastery Series
Therapy Series
 
Bookmark and Share | Print Article | Items for the Week Previous | All Articles This Week | Next
This article originally posted and appeared in  MedicationType 2 DiabetesIssue 546

Good News for Novo's Thrice-Weekly Insulin

A novel insulin that releases over several days showed similar efficacy to standard insulin but without an advantage for hypoglycemia in its first full phase III study....

Advertisement

The results for insulin degludec along with those of a trial that combines insulin degludec with insulin aspart, dubbed DegludecPlus, and the first phase III trial of liraglutide for obesity treatment were released. 

Similar to results of a proof-of-concept study presented at the American Diabetes Association meeting in June, the novel ultra-long-acting insulin degludec reduced hemoglobin A1c by virtually the same degree as insulin glargine (Lantus). 

The 26-week phase IIIa trial in Type 2 diabetes patients previously treated with oral anti-diabetic therapy or basal insulin or both randomized participants to the following on top of existing oral therapy:

  • Insulin degludec in a flexible dosing regimen with eight-to-40-hour intervals between doses
  • Insulin degludec given in the evening
  • Insulin glargine given as labeled
The trial met its primary objective with flexible insulin degludec dosing, showing noninferiority compared with insulin glargine as both arms dropped hemoglobin A1c by 1.3 percentage points, to around 7.2% in both groups. 

Dosing that allowed patients to go days without a shot using the flexible insulin degludec schedule wasn't any less effective for glucose control than once-daily dosing.   Both groups that got the ultra-long-acting insulin tended to see fewer nighttime hypoglycemia episodes compared with insulin glargine. 

The company reported good safety and tolerability of the novel agent without any apparent differences in adverse event rates and safety parameters. 

Novo Nordisk also reported the results of the second phase IIIa study with the novel combination insulin DegludecPlus, premixed insulin degludec and insulin aspart. The study included patients with "late-stage" Type 2 diabetes randomized to receive either DegludecPlus or biphasic insulin aspart (NovoMix 30) twice daily added to their standard oral anti-diabetic therapy.

Results with the insulin degludec combination included:

  • Noninferiority for the primary endpoint of hemoglobin A1c reduction (1.5 percentage points to 7.1% in both groups).
  • Lower fasting and mean plasma glucose levels compared with biphasic insulin aspart
  • Lower total daily insulin dose at study completion compared with biphasic insulin aspart
  • More than two-thirds fewer nocturnal hypoglycemia episodes and significantly fewer confirmed hypoglycemia episodes overall compared with biphasic insulin aspart
  • Slightly less weight gain with DegludecPlus
  • No difference in safety or tolerability
Reported by Novo Nordisk Oct. 2010
Advertisement


 

Bookmark and Share | Print | Category | Home

This article originally posted 03 November, 2010 and appeared in  MedicationType 2 DiabetesIssue 546

Past five issues: Issue 752 | SGLT-2 Inhibitors Special Edition October 2014 | Diabetes Clinical Mastery Series Issue 211 | Issue 751 | Humulin Insulin Special Edition October 2014 |

2014 Most Popular Articles:

FDA Approves Once-Weekly GLP-1 Diabetes Treatment Regimen for T2DM
Posted September 25, 2014
Two Positive Phase 3 Trials for ITCA 650, a GLP-1 Agonist, in Type 2 Diabetes
Posted October 10, 2014
Best Insulin Regimen for Type 1's
Posted October 10, 2014
Stanley Schwartz, MD: A New Way of Classifying Diabetes - The Beta-Cell Centric Approach
Posted September 29, 2014
EASD: Insulin Pumps Lower Mortality Rate 29% Compared to Multiple Injections in T1DM
Posted October 03, 2014
New GLP-1 Receptor Agonist as an Alternative to Insulin Glargine?
Posted October 10, 2014
Adding an SGLT2 to Insulin Improved Control
Posted October 17, 2014
Handbook of Diabetes, 4th Ed., Excerpt #13: Control and Complications
Posted October 13, 2014
Non-Caloric Artificial Sweeteners May Induce Glucose Intolerance
Posted October 10, 2014
Vitamin D and Type 2 Diabetes Risk
Posted October 17, 2014


Browse by Feature Writer & Article Category.
A. Lee Dellon, MD | Aaron I. Vinik, MD, PhD, FCP, MACP | Beverly Price | Charles W Martin, DD | Derek Lowe, PhD | Dr. Brian Jakes, Jr. | Dr. Fred Pescatore | Dr. Tom Burke, Ph.D | Eric S. Freedland | Evan D. Rosen | Ginger Kanzer-Lewis | Greg Milliger | Kristina Sandstedt | Laura Plunkett | Leonard Lipson, M.A. | Louis H. Philipson | Maria Emanuel Ryan, DDS, PhD | Marilyn Porter, RD, CDE | Melissa Diane Smith | Michael R. Cohen, RPh, MS, ScD, FASHP | Paul Chous, M.A., OD | Philip A. Wood PhD | R. Keith Campbell, Professor, B.Pharm, MBA, CDE | Richard K. Bernstein, MD | Sheri R. Colberg PhD | Sherri Shafer | Stanley Schwartz, MD, FACP, FACE | Steve Pohlit | Steven V. Edelman, M.D. | Timothy S. Hollingshead |

Cast Your Vote
Are your patients getting enough glucose strips to manage their diabetes?
CME/CE of the Week
Category: Diabetic Foot
CE Credits: .75
Featured Jobs
Physician - Mission Hospital
Asheville, North Carolina
Pharmacist Analyst - Memorialcare
Long Beach, California
Search Articles On Diabetes In Control