Three-year efficacy of complex insulin regimens in type 2 diabetes.

Full Abstract

BACKGROUND: Evidence supporting the addition of specific insulin regimens to oral therapy in patients with type 2 diabetes mellitus is limited. METHODS: In this 3-year open-label, multicenter trial, we evaluated 708 patients who had suboptimal glycated hemoglobin levels while taking metformin and sulfonylurea therapy. Patients were randomly assigned to receive biphasic insulin aspart twice daily, prandial insulin aspart three times daily, or basal insulin detemir once daily (twice if required). Sulfonylurea therapy was replaced by a second type of insulin if hyperglycemia became unacceptable during the first year of the study or subsequently if glycated hemoglobin levels were more than 6.5%. Outcome measures were glycated hemoglobin levels, the proportion of patients with a glycated hemoglobin level of 6.5% or less, the rate of hypoglycemia, and weight gain. RESULTS: Median glycated hemoglobin levels were similar for patients receiving biphasic (7.1%), prandial (6.8%), and basal (6.9%) insulin-based regimens (P=0.28). However, fewer patients had a level of 6.5% or less in the biphasic group (31.9%) than in the prandial group (44.7%, P=0.006) or in the basal group (43.2%, P=0.03), with 67.7%, 73.6%, and 81.6%, respectively, taking a second type of insulin (P=0.002). Median rates of hypoglycemia per patient per year were lowest in the basal group (1.7), higher in the biphasic group (3.0), and highest in the prandial group (5.7) (P<0.001 for the overall comparison). The mean weight gain was higher in the prandial group than in either the biphasic group or the basal group. Other adverse event rates were similar in the three groups. CONCLUSIONS: Patients who added a basal or prandial insulin-based regimen to oral therapy had better glycated hemoglobin control than patients who added a biphasic insulin-based regimen. Fewer hypoglycemic episodes and less weight gain occurred in patients adding basal insulin. (Current Controlled Trials number, ISRCTN51125379.) 2009 Massachusetts Medical Society

Author information

Author/s: Holman, Rury R (RR); Farmer, Andrew J (AJ); Davies, Melanie J (MJ); Levy, Jonathan C (JC); Darbyshire, Julie L (JL); Keenan, Joanne F (JF); Paul, Sanjoy K (SK); 4-T Study Group;

Affiliation: Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Oxford, United Kingdom. rury.holman(-atsign-)dtu.ox.ac.uk

Journal and publication information

Publication Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

Journal: The New England journal of medicine (N Engl J Med), published in United States. (Language: eng)

Reference: 2009-Oct; vol 361 (issue 18) : pp 1736-47

Dates: Created 2009/10/29; Completed 2009/11/04;

PMID: 19850703, status: MEDLINE (last retrieval date: 11/4/2009, IMS Date: )

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

Comments and Corrections

CommentIn: N Engl J Med. 2009 Oct 29;361(18):1801-3. (PMID: 19850702)

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Hypoglycemia - chemically induced
Hypoglycemic Agents - administration & dosage; adverse effects; therapeutic use
Insulin - administration & dosage; adverse effects
Metformin - therapeutic use
Middle Aged
Sulfonylurea Compounds - therapeutic use
Weight Gain - drug effects

Associated Chemicals: Hemoglobin A, Glycosylated (0) ; Hypoglycemic Agents (0) ; Sulfonylurea Compounds (0) ; Insulin (11061-68-0) ; Metformin (657-24-9)

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