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SHR Neuro Cancer Cardio Lipid Metab Microb
Toplak, H; Hamann, A; Moore, R; Masson, E; Gorska, M; Vercruysse, F; Sun, X; Fitchet, M.
Efficacy and safety of topiramate in combination with metformin in the treatment of obese subjects with type 2 diabetes: a randomized, double-blind, placebo-controlled study.
Int J Obes (Lond). 2007; 31(1): 138-146.
Doi: 10.1038/sj.ijo.0803382
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- Leading authors Med Uni Graz
- Toplak Hermann
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- Abstract:
- OBJECTIVE: To investigate the efficacy and safety of topiramate in obese subjects with type 2 diabetes treated with metformin. DESIGN: This was a multicenter, double-blind, placebo-controlled trial. All subjects received a non-pharmacological program of diet, exercise and behavioral modification throughout the study; the assigned diet was 600 kcal/day less than the subject's individually calculated energy expenditure. After a 6-week single-blind placebo run-in, subjects were randomized to placebo, topiramate 96 mg/day or topiramate 192 mg/day. Following an 8-week titration period, subjects remained on their assigned dose for 52 weeks. However, the sponsor ended the study early in order to develop a new controlled-release formulation with the potential to enhance tolerability and simplify dosing in this patient population. A total of 646 obese men and women (age: 18-75 years, body mass index: 27-50 kg/m(2)) with an established history of type 2 diabetes mellitus controlled by metformin monotherapy were randomized. Efficacy was assessed in a pre-determined modified intent-to-treat (MITT) population of 307 subjects whose randomization date would have allowed them to complete 24 weeks on study medication before the announcement of study termination. MEASUREMENTS: Joint primary efficacy parameters were mean percent change in weight and change in glycosylated hemoglobin (HbA(1c)) from baseline to week 24. RESULTS: Subjects in the placebo, topiramate 96 mg/day and topiramate 192 mg/day groups lost 1.7%, 4.5% (P<0.001) and 6.5% (P<0.001), respectively, of their baseline body weight and had absolute decreases in HbA(1c) of 0.1%, 0.4% (P<0.001) and 0.6% (P<0.001) (MITT, last observation carried forward). Topiramate-treated subjects also experienced statistically significant decreases in systolic blood pressure. Most common adverse events were paresthesia and events related to the central nervous system. CONCLUSIONS: Topiramate was effective for weight reduction and improvement in glycemic control in obese subjects with type 2 diabetes treated with metformin monotherapy. Further study in obese diabetics is warranted.
- Find related publications in this database (using NLM MeSH Indexing)
- Adolescent -
- Adult -
- Aged -
- Anti-Obesity Agents - adverse effects
- Blood Glucose - analysis
- Blood Pressure - physiology
- Diabetes Mellitus, Type 2 - complications
- Double-Blind Method - complications
- Drug Administration Schedule - complications
- Drug Therapy, Combination - complications
- Female - complications
- Fructose - adverse effects
- Hemoglobin A, Glycosylated - analysis
- Humans - analysis
- Hypoglycemic Agents - adverse effects
- Male - adverse effects
- Metformin - adverse effects
- Middle Aged - adverse effects
- Obesity - complications
- Treatment Outcome - complications
- Weight Loss - drug effects
- Find related publications in this database (Keywords)
- topiramate
- type 2 diabetes
- metformin