Premium
A meta‐analysis of rate ratios for nocturnal confirmed hypoglycaemia with insulin degludec vs. insulin glargine using different definitions for hypoglycaemia
Author(s) -
Heller S.,
Mathieu C.,
Kapur R.,
Wolden M. L.,
Zinman B.
Publication year - 2016
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1111/dme.13002
Subject(s) - insulin degludec , medicine , insulin glargine , insulin , diabetes mellitus , population , type 1 diabetes , endocrinology , type 2 diabetes , hazard ratio , type 2 diabetes mellitus , hypoglycemia , confidence interval , environmental health
Abstract Aims A prospective meta‐analysis of phase 3 trials showed lower rates of nocturnal hypoglycaemia with insulin degludec vs. insulin glargine. We investigated the consistency of the results across different definitions of hypoglycaemia. Methods This post‐hoc, patient‐level meta‐analysis included six randomized, controlled, 26‐ or 52‐week phase 3a trials in insulin‐naïve participants with Type 2 diabetes mellitus (Type 2 diabetes insulin naïve ), participants with Type 2 diabetes mellitus using basal−bolus therapy (Type 2 diabetes BB ) and those with Type 1 diabetes mellitus. We used three definitions of hypoglycaemia and different timescales for the nocturnal period. Rates were analysed for the entire core trial period, the ‘maintenance period’ only, and the extension trial set population. Analyses utilized a negative binomial regression model. Results In Type 2 diabetes insulin naïve participants, risk of nocturnal hypoglycaemia was significantly lower with insulin degludec vs. insulin glargine for all hypoglycaemia definitions and trial periods. Risk was also lower for the timescale 21.59–05.59, but not 00.01–07.59. For Type 2 diabetes BB , nocturnal hypoglycaemia rates were lower with insulin degludec vs. insulin glargine across all definitions, timescales and trial periods, with one exception. For individuals with Type 1 diabetes mellitus, nocturnal hypoglycaemia risk was significantly lower with insulin degludec during the maintenance period for the original definition (plasma glucose < 3.1 mmol/l, timescale 00.01–05.59) and in the extension trial set population for all hypoglycaemia definitions except for the nocturnal timescale 00.01–07.59. Conclusions Compared with insulin glargine, insulin degludec is associated with lower rates of nocturnal hypoglycaemia in people with Type 2 diabetes mellitus, and similar or lower rates in Type 1 diabetes mellitus, across different definitions.