Diabetes Mellitus, Adult-Onset, Diabetes Mellitus, Type 2, Obesity
Conditions
Keywords
Type 2 Diabetes, Obesity, Metformin, Hemoglobin A1c, Adult-Onset Diabetes Mellitus (AODM)
Brief summary
The purpose of this study is to compare the efficacy (in terms of weight and hemoglobin type A1c \[HbA1c\]) and safety of topiramate (96 milligrams\[mg\] or 192 mg daily) with placebo in the treatment of obesity in Type 2 diabetic patients receiving metformin.
Detailed description
Topiramate is not approved for the treatment of obesity. This double-blind, placebo-controlled study is designed to assess the efficacy and safety of topiramate in Type 2 diabetic patients with obesity who are well-controlled on metformin alone. Patients are randomized to receive either topiramate (up to a target dose of 96 or 192 mg per day) or placebo for one year. Assessments of efficacy include weight reduction, levels of HbA1c (shows average blood sugar level over a few months), Body Mass Index (BMI), and Health Related Quality of Life (HRQOL) measures. Safety evaluations (incidence of adverse events, vital signs, hypoglycemic events, electrocardiograms \[ECGs\], clinical laboratory values) are monitored throughout the study. The study hypothesis is that topiramate, combined with metformin and non-pharmacologic therapy, can effectively achieve significant weight reduction and is well tolerated. During the first 8 weeks, oral doses of matching placebo or topiramate are increased gradually to target dose (96 milligrams\[mg\] or 192mg daily); the dose will be maintained for 1 year, then gradually reduced and stopped
Interventions
DRUGtopiramate
Sponsors
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Type 2 diabetes and receiving metformin monotherapy for at least the previous 4 months and on a stable daily dose for at least 2 months prior to enrollment * Metformin total daily dose not to exceed 2.1 grams/day * Body Mass Index \>= 27 and \< 50 * HbA1c \< 11% * Fasting plasma glucose \>= 126 and \< 240 * Stable weight * Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, or practicing an acceptable method of contraception (requires negative pregnancy test)
Exclusion criteria
* Known contraindication, or hypersensitivity to topiramate * Use of other antidiabetic medications within the last 4 months * Excessive weight loss * Diagnosis of type 1 diabetes * History of severe or recurrent hypoglycemic episodes * Severe pulmonary disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percent change in body weight and change in HbA1c from baseline (Week 0) to one year after maintenance therapy (Week 60). | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline or from enrollment to Week 60 in BMI and HRQOL measures; safety evaluations, such as adverse events and vital signs throughout study. | — |
Outcome results
None listed