Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial
- Design
- Randomized trial · 9901 participants · Hard outcome
- Match to healthy normal-weight adults aged 55–75
- Different populationAll had type 2 diabetes; notable for including a majority without prior cardiovascular disease and for the longest follow-up of any CVOT (5.4 years). Mean age 66 matches the target age band.
- Could weight loss explain it?
- PossiblySmall weight (-1.5 kg) and HbA1c effects; benefit similar with and without prior CVD (full text).
- Study tier
- Study tier 1[Auto] Large randomized trial with clinical outcomes (auto-provisional; risk of bias and consistency not yet assessed).
- Assessment
- Version 2 · curated · Sep 13, 2026
Study facts come from the paper. Population match, weight-loss explanation and study tier are our judgments, made against the reference group of healthy normal-weight adults aged 55–75.
In 9,901 people with type 2 diabetes, most without prior heart disease, dulaglutide reduced major cardiovascular events by 12% over 5.4 years; total mortality was not significantly changed. Longest follow-up in the class; still confined to diabetes.
01Findings
What the study reported
- Drugs
- Dulaglutide
- Dose
- 1.5 mg once weekly
- Route
- subcutaneous
- Treatment duration
- median 5.4 years
- Comparator
- placebo
- Primary outcome
- Nonfatal MI, nonfatal stroke or CV death
- Effect
- HR 0.88 (12.0% vs 13.4%); all-cause mortality HR 0.90 (NS)
- 95% confidence interval
- 0.79 to 0.99
- P value
- 0.026
- Follow-up
- median 5.4 years
- Adverse events
- GI adverse events 47.4% vs 34.1%.
- Limitations
- Auto-classified from abstract only; effect estimates, adverse events and limitations not extracted. Requires manual review.
Who was studied
- Mean age
- 66.2
- Age min
- 50
- Sex distribution
- 46.3% female
- Diabetes status
- type 2 diabetes required
- Cvd status
- 31% prior CVD; remainder risk factors only (full text)
- Sample size
- 4949
Study quality details
- Study design
- Randomized controlled trial
- Sample size
- 4949
- Randomization
- yes
- Blinding
- double-blind
- Comparator
- placebo
- Follow up duration
- 50 years
- Outcome type
- mixed
- Replication
- not assessed (auto)
- Consistency with other evidence
- not assessed (auto)
- Population applicability
- INDIRECT
- Statistical precision
- CI reported: 95% CI 0·79-0·99
- Risk of bias
- not assessed (auto)
- Funding conflicts
- yes
- Peer review status
- yes
02Funding
Funding and conflicts
- Funding
- Eli Lilly
- Industry funded
- Yes
- Manufacturer
- Eli Lilly
- Sponsor role
- Sponsor designed and analysed.
- Author conflicts
- Authors report Eli Lilly relationships; sponsor co-authors.
- Independent replication
- class-level
- Notes
- Authors declare relationships with the drug's manufacturer: Eli Lilly
Funding is shown on every study and never used to score it.
03Claims
Claims this study bears on
- GLP-1 receptor agonists reduce cardiovascular events in people without obesity or established cardiovascular disease.Mixed
REWIND: benefit in T2D with and without prior CVD (all had diabetes).
04Source
The source, as retrieved
Abstract
[BACKGROUND] Three different glucagon-like peptide-1 (GLP-1) receptor agonists reduce cardiovascular outcomes in people with type 2 diabetes at high cardiovascular risk with high glycated haemoglobin A1c (HbA1c) concentrations. We assessed the effect of the GLP-1 receptor agonist dulaglutide on major adverse cardiovascular events when added to the existing antihyperglycaemic regimens of individuals with type 2 diabetes with and without previous cardiovascular disease and a wide range of glycaemic control. [METHODS] This multicentre, randomised, double-blind, placebo-controlled trial was done at 371 sites in 24 countries. Men and women aged at least 50 years with type 2 diabetes who had either a previous cardiovascular event or cardiovascular risk factors were randomly assigned (1:1) to either weekly subcutaneous injection of dulaglutide (1·5 mg) or placebo. Randomisation was done by a computer-generated random code with stratification by site. All investigators and participants were masked to treatment assignment. Participants were followed up at least every 6 months for incident cardiovascular and other serious clinical outcomes. The primary outcome was the first occurrence of the composite endpoint of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes (including unknown causes), which was assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01394952. [FINDINGS] Between Aug 18, 2011, and Aug 14, 2013, 9901 participants (mean age 66·2 years [SD 6·5], median HbA1c 7·2% [IQR 6·6-8·1], 4589 [46·3%] women) were enrolled and randomly assigned to receive dulaglutide (n=4949) or placebo (n=4952). During a median follow-up of 5·4 years (IQR 5·1-5·9), the primary composite outcome occurred in 594 (12·0%) participants at an incidence rate of 2·4 per 100 person-years in the dulaglutide group and in 663 (13·4%) participants at an incidence rate of 2·7 per 100 person-years in the placebo group (hazard ratio [HR] 0·88, 95% CI 0·79-0·99; p=0·026). All-cause mortality did not differ between groups (536 [10·8%] in the dulaglutide group vs 592 [12·0%] in the placebo group; HR 0·90, 95% CI 0·80-1·01; p=0·067). 2347 (47·4%) participants assigned to dulaglutide reported a gastrointestinal adverse event during follow-up compared with 1687 (34·1%) participants assigned to placebo (p<0·0001). [INTERPRETATION] Dulaglutide could be considered for the management of glycaemic control in middle-aged and older people with type 2 diabetes with either previous cardiovascular disease or cardiovascular risk factors. [FUNDING] Eli Lilly and Company.
Where this record came from
| Source | Retrieved | Identifier |
|---|---|---|
| pubmed | Sep 13, 2026 | 31189511 first ingestion |