RGD Reference Report - SERENADE: the Study Evaluating Rimonabant Efficacy in Drug-naive Diabetic Patients: effects of monotherapy with rimonabant, the first selective CB1 receptor antagonist, on glycemic control, body weight, and lipid profile in drug-naive type 2 diabetes. - Rat Genome Database

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SERENADE: the Study Evaluating Rimonabant Efficacy in Drug-naive Diabetic Patients: effects of monotherapy with rimonabant, the first selective CB1 receptor antagonist, on glycemic control, body weight, and lipid profile in drug-naive type 2 diabetes.

Authors: Rosenstock, J  Hollander, P  Chevalier, S  Iranmanesh, A  Iranmanesh, Ali 
Citation: Rosenstock J, etal., Diabetes Care. 2008 Nov;31(11):2169-76. Epub 2008 Aug 4.
RGD ID: 2314632
Pubmed: PMID:18678611   (View Abstract at PubMed)
PMCID: PMC2571069   (View Article at PubMed Central)
DOI: DOI:10.2337/dc08-0386   (Journal Full-text)

OBJECTIVE: The purpose of this study was to assess the glucose-lowering efficacy and safety of rimonabant monotherapy in drug-naive type 2 diabetic patients. RESEARCH DESIGN AND METHODS: The Study Evaluating Rimonabant Efficacy in Drug-Naive Diabetic Patients (SERENADE) was a 6-month, randomized, double-blind, placebo-controlled trial of 20 mg/day rimonabant in drug-naive patients with type 2 diabetes (A1C 7-10%). The primary end point was A1C change from baseline; secondary end points included body weight, waist circumference, and lipid profile changes. RESULTS: A total of 281 patients were randomly assigned; 278 were exposed to treatment, and 236 (84.9%) completed the study. Baseline A1C (7.9%) was reduced by -0.8% with rimonabant versus -0.3% with placebo (Delta A1C -0.51%; P = 0.0002), with a larger rimonabant effect in patients with baseline A1C >or=8.5% (Delta A1C -1.25%; P = 0.0009). Weight loss from baseline was -6.7 kg with rimonabant versus -2.8 kg with placebo (Delta weight -3.8 kg; P < 0.0001). Rimonabant induced improvements from baseline in waist circumference (-6 vs. -2 cm; P < 0.0001), fasting plasma glucose (-0.9 vs. -0.1 mmol/l; P = 0.0012), triglycerides (-16.3 vs. +4.4%; P = 0.0031), and HDL cholesterol (+10.1 vs. +3.2%; P < 0.0001). Adverse events of interest that occurred more frequently with rimonabant versus placebo were dizziness (10.9 vs. 2.1%), nausea (8.7 vs. 3.6%), anxiety (5.8 vs. 3.6%), depressed mood (5.8 vs. 0.7%), and paresthesia (2.9 vs. 1.4%). CONCLUSIONS: Rimonabant monotherapy resulted in meaningful improvements in glycemic control, body weight, and lipid profile in drug-naive type 2 diabetic patients. Further ongoing studies will better establish the benefit-to-risk profile of rimonabant and define its place in type 2 diabetes management.

RGD Manual Disease Annotations    Click to see Annotation Detail View
TermQualifierEvidenceWithReferenceNotesSourceOriginal Reference(s)
type 2 diabetes mellitus  IMP 2314632 RGD 
type 2 diabetes mellitus  ISOCNR1 (Homo sapiens)2314632; 2314632 RGD 

Objects Annotated

Genes (Rattus norvegicus)
Cnr1  (cannabinoid receptor 1)

Genes (Mus musculus)
Cnr1  (cannabinoid receptor 1)

Genes (Homo sapiens)
CNR1  (cannabinoid receptor 1)


Additional Information