Reduced Risk of Hypoglycemia with Insulin Degludec Versus Insulin Glargine in Patients with Type 2 Diabetes Requiring High Doses of Basal Insulin: Meta-Analysis of Five Randomized Begin Trials.
Endocr Pract. 2013 Nov 18;:1-23
Authors: Rodbard HW, Gough S, Lane W, Korsholm L, Bretler DM, Handelsman Y
Objective: This meta-analysis of five trials from the phase 3a insulin degludec (IDeg) clinical trial program evaluated the risk of hypoglycemia in a subset of subjects with type 2 diabetes (T2D) who required high basal insulin doses at end-of-trial.Methods: This meta-analysis compared HbA1c, fasting plasma glucose (FPG), basal insulin dose, body weight, and rates of overall and nocturnal confirmed hypoglycemia in a pooled population of T2D subjects using >60U of basal insulin at trial completion. Five phase 3a, open-label, randomized, treat-to-target, confirmatory 26- or 52-week trials with IDeg (n=2,262) versus insulin glargine (IGlar) (n=1,110) administered once-daily were included. Overall confirmed hypoglycemia was defined as self-measured blood glucose <56 mg/dL or any episode requiring assistance; nocturnal confirmed hypoglycemia had an onset between 00:01-05:59 AM, inclusive.Results: At end-of-trial, more than one-third of IDeg- (35%) and IGlar- (34%) treated T2D subjects required >60U of basal insulin daily. Patients achieved similar mean HbA1c values (estimated treatment difference [ETD] IDeg-IGlar: 0.05%, P=0.44, NS) while mean FPG values were lower with IDeg than IGlar (ETD: -5.9 mg/dL, P<0.04) at end-of-trial. There was a 21% lower rate of overall confirmed hypoglycemic episodes for IDeg (estimated rate ratio [RR] IDeg/IGlar: 0.79, P=0.02) and 52% lower rate of nocturnal confirmed hypoglycemic episodes for IDeg (RR: 0.48, P<0.01).Conclusion: In this post hoc meta-analysis, >30% of subjects with T2D required >60 U/day of basal insulin. In these individuals, IDeg achieves similar HbA1c reduction with significantly less overall and nocturnal confirmed hypoglycemia compared with IGlar.
PMID: 24246344 [PubMed - as supplied by publisher]