Evidence map›Paper›PMID 18678611›Full record

Trial reportDiabetes care2008

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.

Julio Rosenstock, Priscilla Hollander, Soazig Chevalier, Ali Iranmanesh, SERENADE Study Group

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes care, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 49 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 1 pooled it
9.0field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 1 synthesis or guideline pooled it, 122 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Review
  7. Review
  8. Article
  9. Article
  10. Hepatic targeting of the centrally active cannabinoid 1 receptor (CBJournal of controlled release : official journal of the Controlled Release Society · 2023
    Article
  11. Review
  12. The effects of cannabis and cannabinoids on the endocrine system.Reviews in endocrine & metabolic disorders · 2022
    Review
  13. Review
  14. Metabolic Consequences of Gestational Cannabinoid Exposure.International journal of molecular sciences · 2021
    Review
  15. Review
  16. Review
  17. Druggable Targets in Endocannabinoid Signaling.Advances in experimental medicine and biology · 2020
    Review
  18. Article
  19. Toxins · 2019
    Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 4 institutions in 2 countries.

Julio RosenstockDallas Diabetes and Endocrine Center, Dallas, Texas, USA. juliorosenstock@dallasdiabetes.com
Priscilla Hollander
Soazig Chevalier
Ali Iranmanesh
SERENADE Study Group
Baylor University Medical Center · USDallas Diabetes Research Center · USSalem VA Medical Center · USSanofi (France) · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe 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

methodsThe 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.

resultsA 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%).

conclusionsRimonabant 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.

Indexed as

AgedBlood GlucoseBody WeightDiabetes Mellitus, Type 2Double-Blind MethodFemaleHumansLipid MetabolismLipidsMaleMiddle AgedPiperidinesPyrazolesReceptor, Cannabinoid, CB1RimonabantTreatment OutcomeBlood GlucoseLipidsPiperidinesPyrazolesReceptor, Cannabinoid, CB1Rimonabant

Identifiers

PMID18678611
PMCPMC2571069
OpenAlexW2126940436

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.