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 766 | Diabetes Clinical Mastery Series Issue 225 | Issue 765 | Diabetes Clinical Mastery Series Issue 224 | Issue 764 |

2014 Most Popular Articles:

Significant Weight Loss and Drop in A1c with New Combo of Lorcaserin and Phentermine
Posted January 16, 2015
ADA Issues New Standards of Medical Care for Diabetes
Posted January 02, 2015
New Guideline Released on Pharmacological Management of Obesity
Posted January 23, 2015
Dr. Timothy Garvey on Qsymia and Other New Therapies for Weight Loss
Posted January 12, 2015
Handbook of Diabetes, 4th Ed., Excerpt #25: Specific Circumstances that Affect Diabetes Control
Posted January 04, 2015
For Your Patients: Practical Advice to Rev Up Your Workouts and Lower Fatigue
Posted January 09, 2015
Phentermine and Topirimate ER (Qsymia) Studied for Type 2 Diabetes Patients
Posted January 15, 2015
New Guidelines Recommend Off-Loading to Increase Likelihood of Diabetic Foot Ulcer Healing
Posted December 26, 2014
New Insulin Glargine 300 Effective in Type 1 Diabetes
Posted January 16, 2015
FDA Approves Weight-management Drug Saxenda
Posted December 26, 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
Will you prescribe inhaled insulin (Afrezza) when it becomes available this year?
CME/CE of the Week
Category: Diabetic Foot
CE Credits: .75
Search Articles On Diabetes In Control