A 26-week, Randomized, Parallel, Treat-to-target Trial Comparing Insulin Detemir with Nph Insulin As Add-on Therapy to Oral Glucose-lowering Drugs in Insulin-naive People with Type 2 Diabetes.
From: Department of Endocrinology and Metabolism, Aarhus Sygehus THG, Aarhus University Hospital, DK-8000 Aarhus C, Denmark. kjeld.hermansen@as.aaa.dk
Diabetes care
- Publish Date: Jun 2006
- ISSN: 0149-5992
- Volume: 29
- Issue: 6
- Pages: 1269-74
- Medium: Print
- Language: English
- Citation (JAMA): Hermansen Kjeld, Davies Melanie, Derezinski Taudeusz, et al. A 26-week, Randomized, Parallel, Treat-to-target Trial Comparing Insulin Detemir with Nph Insulin As Add-on Therapy to Oral Glucose-lowering Drugs in Insulin-naive People with Type 2 Diabetes.. Diabetes Care Jun 2006;29:1269-74
Abstract
OBJECTIVE: To assess efficacy and tolerability of insulin detemir or NPH insulin added to oral therapy for type 2 diabetes in a treat-to-target titration protocol. RESEARCH DESIGN AND METHODS: Individuals (n = 476) with HbA(1c) (A1C) 7.5-10.0% were randomized to addition of twice-daily insulin detemir or NPH insulin in a parallel-group, multicenter trial. Over 24 weeks, insulin doses were titrated toward prebreakfast and predinner plasma glucose targets of < or =6.0 mmol/l (< or =108 mg/dl). Outcomes assessed included A1C, percentage achieving A1C < or =7.0%, risk of hypoglycemia, and body weight. RESULTS: At 24 weeks, A1C had decreased by 1.8 and 1.9% (from 8.6 to 6.8 and from 8.5 to 6.6%) for detemir and NPH, respectively (NS). In both groups, 70% of participants achieved an A1C NPH insulin (34% [corrected] vs. 25[corrected]%, P = 0.052[corrected]). Compared with NPH insulin, the risk for all hypoglycemia with insulin detemir was reduced by 47% (P < 0.001) and nocturnal hypoglycemia by 55% (P < 0.001). Mean weight gain was 1.2 kg with insulin detemir and 2.8 kg with NPH insulin (P < 0.001), and the difference in baseline-adjusted final weight was -1.58 (P < 0.001). CONCLUSIONS: Addition of basal insulin to oral drug therapy in people with suboptimal control of type 2 diabetes achieves guideline-recommended A1C values in most people with aggressive titration. Insulin detemir compared with NPH insulin achieves this with reduced hypoglycemia and less weight gain.
Mesh Headings (Keywords): Administration, Oral, Adult, Blood Glucose, Body Mass Index, Body Weight, Diabetes Mellitus, Type 2, Drug Therapy, Combination, Hemoglobin A, Glycosylated, Humans, Hypoglycemic Agents, Insulin, Insulin, Isophane, Weight Gain
Check for Full Text / PubMed Unique Identifier (PMID): 16732007
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