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Effect of rimonabant on glycemic control in insulin-treated type 2 diabetes: the ARPEGGIO trial
Priscilla A Hollander1, Aslam Amod, León E Litwak
1Baylor University Medical Center, Dallas, Texas, USA. priscilh@baylorhealth.edu
Abstract:
OBJECTIVE To examine the efficacy and safety of rimonabant, a selective cannabinoid receptor type-1 antagonist, in patients with type 2 diabetes receiving insulin monotherapy. RESEARCH DESIGN AND METHODS Patients (n = 368; A1C > or =7%) were randomized to 20 mg/day rimonabant or placebo in this 48-week, double-blind, placebo-controlled multicenter trial. Change in baseline A1C to week 48 (primary outcome) and changes in body weight, waist circumference, and lipid levels (secondary outcomes) were assessed. RESULTS Rimonabant significantly reduced baseline A1C versus placebo (-0.89 vs. -0.24%; P < 0.0001), and significantly greater improvements were observed in cardiometabolic risk factors. More rimonabant patients achieved >10% reduction in mean total daily insulin dose versus placebo (P = 0.0012), and fewer required rescue medication (P < 0.0001). Hypoglycemia, nausea, dizziness, anxiety, and depression were more frequent with rimonabant. CONCLUSIONS Rimonabant improved glycemic control and cardiometabolic risk factors in patients with type 2 diabetes receiving insulin.
Insights
Rimonabant improved glycemic control and reduced insulin dosage in type 2 diabetes patients. However, it increased adverse events like hypoglycemia and mood changes.
Area of Science:
- Endocrinology
- Metabolic Disorders
- Pharmacology
Background:
- Type 2 diabetes is a growing global health concern.
- Insulin therapy is common but can be associated with weight gain and suboptimal glycemic control.
- Selective cannabinoid receptor type-1 antagonists represent a novel therapeutic approach.
Purpose of the Study:
- To evaluate the efficacy and safety of rimonabant in type 2 diabetes patients on insulin.
- To assess rimonabant's impact on glycemic control (HbA1c) and cardiometabolic risk factors.
- To determine changes in insulin dosage requirements and need for rescue medication.
Main Methods:
- A 48-week, double-blind, placebo-controlled, multicenter trial.
- 368 patients with type 2 diabetes (HbA1c > or =7%) receiving insulin monotherapy were randomized.
- Primary outcome: change in HbA1c from baseline to week 48. Secondary outcomes: changes in body weight, waist circumference, and lipid levels.
Main Results:
- Rimonabant significantly reduced HbA1c compared to placebo (-0.89% vs. -0.24%, P < 0.0001).
- Significant improvements in cardiometabolic risk factors were observed with rimonabant.
- More patients on rimonabant achieved >10% reduction in daily insulin dose and required less rescue medication.
Conclusions:
- Rimonabant effectively improved glycemic control in type 2 diabetes patients on insulin.
- Rimonabant positively impacted cardiometabolic risk factors and reduced insulin requirements.
- Increased incidence of adverse events including hypoglycemia, nausea, dizziness, anxiety, and depression necessitates careful consideration.
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