Evidence map›Paper›PMID 17098084›Full record

Trial reportLancet (London, England)2006

Efficacy and tolerability of rimonabant in overweight or obese patients with type 2 diabetes: a randomised controlled study.

André J Scheen, Nick Finer, Priscilla Hollander, Michael D Jensen, Luc F Van Gaal, RIO-Diabetes Study Group

Erratum issued Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Lancet (London, England), 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00029848 (A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study of Weight-Reducing Effect and Safety in Obese Patients With Type 2 Diabetes), which is not on this map. Cited by 187 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
187citing papers in PubMed, 7 pooled it
101.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00029848 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study of Weight-Reducing Effect and Safety in Obese Patients With Type 2 Diabetes

TypeinterventionalSponsorSanofiRan2001 to 2004Enrolled1,045ConditionsObesity, Diabetes Mellitus, Non-Insulin-Dependent, Obesity in DiabetesArmsRimonabant (SR141716)
3 · Its place in the literature

Who cites it

187 citing papers in PubMed, 7 syntheses or guidelines pooled it, 735 citations in OpenAlex.

  1. Pooled it
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  3. Long-term effects of weight-reducing drugs in people with hypertension.The Cochrane database of systematic reviews · 2021
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  6. Attrition from randomized controlled trials of pharmacological weight loss agents: a systematic review and analysis.Obesity reviews : an official journal of the International Association for the Study of Obesity · 2009
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  7. Long-term pharmacotherapy for obesity and overweight.The Cochrane database of systematic reviews · 2004
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  12. Does rimonabant independently affect free fatty acid and glucose metabolism?The Journal of clinical endocrinology and metabolism · 2012
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127 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 5 institutions in 3 countries.

André J ScheenDivision of Diabetes, Nutrition and Metabolic Disorders, CHU Sart Tilman, University of Liege, Liege, Belgium. andre.scheen@chu.ulg.ac.be
Nick Finer
Priscilla Hollander
Michael D Jensen
Luc F Van Gaal
RIO-Diabetes Study Group
Antwerp University Hospital · BEBaylor University Medical Center · USCentre Hospitalier Universitaire de Liège · BEMayo Clinic in Florida · USUniversity of Cambridge · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRimonabant, a selective cannabinoid type 1 receptor blocker, reduces bodyweight and improves cardiovascular and metabolic risk factors in non-diabetic overweight or obese patients. The aim of the RIO-Diabetes trial was to assess the efficacy and safety of rimonabant in overweight or obese patients with type 2 diabetes that was inadequately controlled by metformin or sulphonylureas.

methods1047 overweight or obese type 2 diabetes patients (body-mass index 27-40 kg/m2) with a haemoglobin A1c (HbA1c) concentration of 6.5-10.0% (mean 7.3% [SD 0.9] at baseline) already on metformin or sulphonylurea monotherapy were given a mild hypocaloric diet and advice for increased physical activity, and randomly assigned placebo (n=348), 5 mg/day rimonabant (360) or 20 mg/day rimonabant (339) for 1 year. Two individuals in the 5 mg/day group did not receive double-blind treatment and were thus not included in the final analysis. The primary endpoint was weight change from baseline after 1 year of treatment. Analyses were done on an intention-to-treat basis. This trial is registered at ClinicalTrials.gov, number NCT00029848.

findings692 patients completed the 1 year follow-up; numbers in each group after 1 year were much the same. Weight loss was significantly greater after 1 year in both rimonabant groups than in the placebo group (placebo: -1.4 kg [SD 3.6]; 5 mg/day: -2.3 kg [4.2], p=0.01 vs placebo; 20 mg/day: -5.3 kg [5.2], p<0.0001 vs placebo). Rimonabant was generally well tolerated. The incidence of adverse events that led to discontinuation was slightly greater in the 20 mg/day rimonabant group, mainly due to depressed mood disorders, nausea, and dizziness.

interpretationThese data indicate that 20 mg/day rimonabant, in combination with diet and exercise, can produce a clinically meaningful reduction in bodyweight and improve HbA1c and a number of cardiovascular and metabolic risk factors in overweight or obese patients with type 2 diabetes inadequately controlled by metformin or sulphonylureas.

Indexed as

AdolescentAdultAgedBlood GlucoseCannabinoid Receptor AntagonistsDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDouble-Blind MethodDrug ToleranceFemaleGlycated HemoglobinHumansMaleMiddle AgedObesityOverweightBlood GlucoseCannabinoid Receptor AntagonistsGlycated HemoglobinPiperidinesPyrazolesRimonabant

Identifiers

PMID17098084
OpenAlexW2165284792

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.