Trial reportDiabetes care2003
A randomized trial of sibutramine in the management of obese type 2 diabetic patients treated with metformin.
Trial report in Diabetes care, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00941382 (Double-blind, Randomized Clinical Trial to Evaluate Effect of Combination Therapy of Metformin and Sibutramine Versus Metformin or Sibutramine Monotherapy Over Weight, Adiposity, Glucose Metabolism and Inflammatory State in Obese Patients), which is not on this map. Cited by 31 papers, 5 of them syntheses that pooled 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.
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.
Double-blind, Randomized Clinical Trial to Evaluate Effect of Combination Therapy of Metformin and Sibutramine Versus Metformin or Sibutramine Monotherapy Over Weight, Adiposity, Glucose Metabolism and Inflammatory State in Obese Patients
Who cites it
31 citing papers in PubMed, 5 syntheses or guidelines pooled it, 167 citations in OpenAlex.
- Long-term effects of weight-reducing drugs in people with hypertension.The Cochrane database of systematic reviews · 2021Pooled it
- Second-line therapy in patients with type 2 diabetes inadequately controlled with metformin monotherapy: a systematic review and mixed-treatment comparison meta-analysis.Open medicine : a peer-reviewed, independent, open-access journal · 2011Pooled it
- 2006 Canadian clinical practice guidelines on the management and prevention of obesity in adults and children [summary].CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2007Guideline
- Pharmacotherapy for weight loss in adults with type 2 diabetes mellitus.The Cochrane database of systematic reviews · 2005Pooled it
- Long-term pharmacotherapy for obesity and overweight.The Cochrane database of systematic reviews · 2004Pooled it
- Sibutramine promotes amygdala activity under fasting conditions in obese women.Psychopharmacology · 2012Trial
- Does a weight loss medicine make sense for obese type 2 diabetes? New information on endocannabinoid blockers.Current diabetes reports · 2007Trial
- Efficacy and safety of sibutramine in 2225 subjects with cardiovascular risk factors: short-term, open-label, observational study.Journal of human hypertension · 2005Trial
- Metformin treatment of juvenile mice alters aging-related developmental and metabolic phenotypes in sex-dependent and sex-independent manners.GeroScience · 2024Article
- Pharmacologic Treatment of Obesity in adults and its impact on comorbidities: 2024 Update and Position Statement of Specialists from the Brazilian Association for the Study of Obesity and Metabolic Syndrome (Abeso) and the Brazilian Society of Endocrinology and Metabolism (SBEM).Archives of endocrinology and metabolism · 2024Review
- 5-HTNutrients · 2023Review
- Therapeutics in Metabolic Diseases.Advances in experimental medicine and biology · 2023Article
- Design, Synthesis, and Biological Evaluation of a Novel Series of 4-Guanidinobenzoate Derivatives as Enteropeptidase Inhibitors with Low Systemic Exposure for the Treatment of Obesity.Journal of medicinal chemistry · 2022Article
- Review
- Role of serotonin in body weight, insulin secretion and glycaemic control.Journal of neuroendocrinology · 2021Review
- SCO-792, an enteropeptidase inhibitor, improves disease status of diabetes and obesity in mice.Diabetes, obesity & metabolism · 2019Article
- Safety of antiobesity drugs.Therapeutic advances in drug safety · 2013Article
- Drug treatment for obesity in the post-sibutramine era.Drug safety · 2011Article
- Rise and fall of anti-obesity drugs.World journal of diabetes · 2011Article
- Present and future: pharmacologic treatment of obesity.Journal of obesity · 2011Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the effects of sibutramine (15 and 20 mg/day) on weight, metabolic control, and blood pressure in metformin-treated obese subjects with type 2 diabetes. RESEARCH DESIGN AND
methodsA 12-month randomized prospective placebo-controlled double-blind study was performed. It included 21 primary and secondary care centers in England, Canada, France, and Belgium. A total of 195 subjects (44% male) with type 2 diabetes and a BMI >27 kg/m(2) were studied. Changes were assessed in weight, blood pressure and resting heart rate, HbA(1c), fasting glucose, and lipids.
resultsSibutramine induced significant weight loss (P < 0.001) with both 15 mg/day (5.5 +/- 0.6 kg at 12 months) and 20 mg/day (8.0 +/- 0.9 kg), whereas placebo did not (0.2 +/- 0.5 kg). Weight loss > or = 10% was achieved by 14 and 27% of subjects receiving 15 and 20 mg, respectively, but by none given placebo. Glycemic control improved in parallel with weight loss, and subjects who lost > or = 10% weight showed significant decreases in both HbA(1c) (1.2 +/- 0.4%, P < 0.0001) and fasting plasma glucose (1.8 mmol/l, P < 0.001). HDL cholesterol increased slightly with the higher dose, whereas plasma triglycerides fell with both doses, especially in subjects with weight loss of > or = 10% (a 29% decrease, P < 0.01). Treatment was generally well tolerated. Sibutramine treatment raised sitting diastolic blood pressure by > or = 5 mmHg in a higher proportion of patients than did placebo (43% with 15 mg/day vs. 25% with placebo, P < 0.05), but this effect was less evident in subjects who had a weight loss of > or = 10% weight. Pulse rate increased significantly more with sibutramine, being > or = 10 bpm higher in 42% of treated patients versus 17% with placebo (P < 0.01).
conclusionsSibutramine can be an effective adjunct to metformin treatment in selected obese type 2 diabetic subjects and improves metabolic control in individuals who lose weight.
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What OpenQuestion holds
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.