Evidence map›Paper›PMID 24144653›Full record

Trial reportDiabetes care2013

Effects of naltrexone sustained-release/bupropion sustained-release combination therapy on body weight and glycemic parameters in overweight and obese patients with type 2 diabetes.

Priscilla Hollander, Alok K Gupta, Raymond Plodkowski, Frank Greenway, Harold Bays, Colleen Burns, Preston Klassen, Ken Fujioka, COR-Diabetes Study Group

Erratum issued Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes care, 2013. 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 NCT00474630 (A Multicenter, Randomized, Double Blind, Placebo Controlled Study Comparing the Safety and Efficacy of Naltrexone 32 mg Sustained Release), which is not on this map. Cited by 192 papers, 18 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
192citing papers in PubMed, 18 pooled it
28.4field-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.

NCT00474630 phase3completednot on this map

A Multicenter, Randomized, Double Blind, Placebo Controlled Study Comparing the Safety and Efficacy of Naltrexone 32 mg Sustained Release (SR)/Bupropion 360 mg Sustained Release (SR) and Placebo in Obese Subjects With Type 2 Diabetes Mellitus

TypeinterventionalSponsorOrexigen Therapeutics, IncRan2007 to 2009Enrolled505ConditionsObesity, Overweight, Diabetes Mellitus, Type 2ArmsNaltrexone SR 32 mg/bupropion SR 360 mg/ day, Placebo, Ancillary therapy
3 · Its place in the literature

Who cites it

192 citing papers in PubMed, 18 syntheses or guidelines pooled it, 483 citations in OpenAlex.

  1. Pooled it
  2. Long-term effects of weight-reducing drugs in people with hypertension.The Cochrane database of systematic reviews · 2026 · on this map
    Pooled it
  3. Guideline
  4. Pooled it
  5. Pooled it
  6. CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2025
    Guideline
  7. Pharmacotherapy for obesity management in adults: 2025 clinical practice guideline update.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2025
    Guideline
  8. Guideline
  9. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022
    Guideline
  10. Pooled it
  11. Guideline
  12. Long-term effects of weight-reducing drugs in people with hypertension.The Cochrane database of systematic reviews · 2021
    Pooled it
  13. Pooled it
  14. Pooled it
  15. Pooled it
  16. Pooled it
  17. Food cue reactivity and craving predict eating and weight gain: a meta-analytic review.Obesity reviews : an official journal of the International Association for the Study of Obesity · 2016
    Pooled it
  18. European Guidelines for Obesity Management in Adults.Obesity facts · 2015 · on this map
    Guideline
  19. Trial
  20. Trial

132 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

9 authors at 6 institutions in 1 country.

Priscilla HollanderCorresponding author: Priscilla Hollander, priscilh@baylorhealth.edu.
Alok K Gupta
Raymond Plodkowski
Frank Greenway
Harold Bays
Colleen Burns
Preston Klassen
Ken Fujioka
COR-Diabetes Study Group
Scripps Clinic · USVistaGen Therapeutics (United States) · USBaylor University Medical Center · USLouisiana State University System · USLouisville Metabolic and Atherosclerosis Research Center · USPennington Biomedical Research Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the efficacy and safety of 32 mg naltrexone sustained-release (SR)/360 mg bupropion SR (NB) in overweight/obese individuals with type 2 diabetes with or without background oral antidiabetes drugs. RESEARCH DESIGN AND

methodsThis was a 56-week, double-blind, placebo-controlled study in which 505 patients received standardized lifestyle intervention and were randomized 2:1 to NB or placebo. Coprimary end points were percent weight change and achievement of ≥5% weight loss. Secondary end points included achievement of HbA1c <7% (53 mmol/mol), achievement of weight loss ≥10%, and change in HbA1c, waist circumference, fasting blood glucose, and lipids.

resultsIn the modified intent-to-treat population (54% female, 80% Caucasian, and mean age 54 years, weight 106 kg, BMI 37 kg/m(2), and HbA1c 8.0% [64 mmol/mol]), NB resulted in significantly greater weight reduction (-5.0 vs. -1.8%; P < 0.001) and proportion of patients achieving ≥5% weight loss (44.5 vs. 18.9%, P < 0.001) compared with placebo. NB also resulted in significantly greater HbA1c reduction (-0.6 vs. -0.1% [6.6 vs. 1.1 mmol/mol]; P < 0.001), percent of patients achieving HbA1c <7% (53 mmol/mol) (44.1 vs. 26.3%; P < 0.001), and improvement in triglycerides and HDL cholesterol compared with placebo. NB was associated with higher incidence of nausea (42.3 vs. 7.1%), constipation (17.7 vs. 7.1%), and vomiting (18.3 vs. 3.6%). No difference was observed between groups in the incidence of depression, suicidal ideation, or hypoglycemia.

conclusionsNB therapy in overweight/obese patients with type 2 diabetes induced weight loss, which was associated with improvements in glycemic control and select cardiovascular risk factors and was generally well tolerated with a safety profile similar to that in patients without diabetes.

Indexed as

AdolescentAdultAgedAntidepressive Agents, Second-GenerationBlood GlucoseBody WeightBupropionDelayed-Action PreparationsDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDouble-Blind MethodDrug Therapy, CombinationFemaleFollow-Up StudiesHumansMaleAntidepressive Agents, Second-GenerationBlood GlucoseBupropionDelayed-Action PreparationsNaltrexoneNarcotic Antagonists

Identifiers

PMID24144653
PMCPMC3836105
OpenAlexW2020982355

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.