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Dul7.0
Dulaglutide Research
Mostly mechanism / observationalLimited safety
12 peer-reviewed studies
What the evidence says
Mostly mechanism / observational
Most Dulaglutide studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.
Most evidence is from high-quality meta-analyses and randomised trials published 2014–2021 with a typical study size of 1,201 participants.
Based on 12 studies · 2 meta-analyses · 10 RCTs · 35,091 total participants
Confidence
High
By outcome
Blood sugar & glycemic control
Mostly mechanism / observational12 studies
Safety & adverse effects
Mostly mechanism / observational5 studies
Weight management
Mostly mechanism / observational4 studies
Cardiovascular outcomes
Too few graded studies2 studies
Slowing down
Only 1 study in the last 5 years · Latest meta-analysis: 2020
20142021
1RCTn=9,901 · very large study2019
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).
Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, Probstfield J, Riesmeyer JS, Riddle MC, Rydén L, Xavier D, Atisso CM, Dyal L, Hall S, Rao-Melacini P, Wong G, Avezum A, Basile J, Chung N, Conget I, Cushman WC, Franek E, Hancu N, Hanefeld M, Holt S, Jansky P, Keltai M, Lanas F, Leiter LA, Lopez-Jaramillo P, Cardona Munoz EG, Pirags V, Pogosova N, Raubenheimer PJ, Shaw JE, Sheu WH, Temelkova-Kurktschiev T; REWIND Investigators. · Lancet (2019)
Multicentre, double-blind, placebo-controlled cardiovascular-outcomes RCT: 9,901 patients aged ≥50 with type 2 diabetes, randomized to subcutaneous dulaglutide 1.5 mg/week or placebo at 371 sites in 24 countries
First occurrence of cardiovascular death, non-fatal MI, or non-fatal stroke reduced 12% (HR 0.88, 95% CI 0.79-0.99; p=0.026) over median 5.4 years
Notable because the majority of participants did NOT have established cardiovascular disease — a primary-prevention-weighted population
Overall, GLP-1 receptor agonist treatment reduced MACE by 12% (HR 0.88, 95% CI 0.82-0.94; p<0.0001)... a broad composite kidney outcome by 17% (0.83, 0.78-0.89; p<0.0001)... There was no increase in risk of severe hypoglycaemia, pancreatitis, or pancreatic cancer.
Class-level 12% reduction in MACE (HR 0.88, 95% CI 0.82-0.94), with 12% lower cardiovascular and all-cause mortality and 9% fewer heart-failure hospitalizations
17% reduction in a composite kidney outcome (HR 0.83), mainly driven by reduced urinary albumin excretion
Insulin regimens and specific glucagon-like peptide-1 receptor agonists (GLP-1 RAs) added to metformin-based background therapy produced the greatest reductions in hemoglobin A1c.
Tsapas A, Avgerinos I, Karagiannis T, Malandris K, Manolopoulos A, Andreadis P, Liakos A, Matthews DR, Bekiari E. · Ann Intern Med (2020)
Network meta-analysis of 453 trials assessing 21 antidiabetic interventions across 9 drug classes
GLP-1 receptor agonists (including dulaglutide) added to metformin-based therapy were among the most effective for HbA1c reduction
In patients at increased cardiovascular risk, specific GLP-1 RAs and SGLT2 inhibitors favorably affected vascular outcomes
Mean percentage HbA1c was reduced by 1.8 percentage points with semaglutide 1.0 mg versus 1.4 percentage points with dulaglutide 1.5 mg... bodyweight was reduced by 6.5 kg vs 3.0 kg.
Pratley RE, Aroda VR, Lingvay I, Lüdemann J, Andreassen C, Navarria A, Viljoen A; SUSTAIN 7 investigators. · Lancet Diabetes Endocrinol (2018)
Head-to-head open-label phase-3b RCT: 1,201 metformin-treated type 2 diabetes patients, semaglutide vs dulaglutide at matched dose levels for 40 weeks
Semaglutide reduced HbA1c more than dulaglutide (e.g. -1.8 vs -1.4 percentage points at high dose; P<0.0001)
Greater weight loss with semaglutide (6.5 kg vs 3.0 kg at high dose) — an honest counterweight showing dulaglutide is not the most potent GLP-1 agonist on these endpoints
The primary outcome was non-inferiority (margin 0.4%) of dulaglutide compared with liraglutide for change in HbA1c (least-squares mean change from baseline) at 26 weeks.
Least squares mean HbA1c change from baseline to the primary end point was -1.51% for dulaglutide 1.5 mg... -0.99% for exenatide, and -0.46% for placebo. Both dulaglutide doses were superior to placebo at 26 weeks and exenatide at 26 and 52 weeks.
Wysham C, Blevins T, Arakaki R, Colon G, Garcia P, Atisso C, Kuhstoss D, Lakshmanan M. · Diabetes Care (2014)
52-week phase-3 RCT (primary endpoint 26 weeks) in type 2 diabetes on metformin + pioglitazone, randomized to dulaglutide 1.5/0.75 mg, twice-daily exenatide 10 µg, or placebo
HbA1c fell -1.51% (dulaglutide 1.5 mg) vs -0.99% (exenatide) vs -0.46% (placebo); both dulaglutide doses superior to placebo and exenatide (P<0.001)
Lower total hypoglycemia than exenatide; no severe hypoglycemia with dulaglutide
The least squares mean HbA1c change from baseline to the primary end point was -1.08% for dulaglutide 1.5 mg... and -0.63% for glargine... Statistical criteria for superiority were met with dulaglutide 1.5 mg. Body weight decreased with dulaglutide and increased with glargine.
Giorgino F, Benroubi M, Sun JH, Zimmermann AG, Pechtner V. · Diabetes Care (2015)
78-week open-label phase-3 RCT in 810 type 2 diabetes patients on metformin + glimepiride, randomized to dulaglutide 1.5/0.75 mg or insulin glargine
Dulaglutide 1.5 mg superior to glargine on HbA1c (-1.08% vs -0.63%) at 52 weeks
Body weight decreased with dulaglutide but increased with insulin glargine; total hypoglycemia rates lower with dulaglutide
In patients with type 2 diabetes inadequately controlled by metformin, escalation from dulaglutide 1.5 mg to 3.0 mg or 4.5 mg provided clinically relevant, dose-related reductions in HbA1c.
Frias JP, Bonora E, Nevarez Ruiz L, Li YG, Yu Z, Milicevic Z, Malik R, Bethel MA, Cox DA. · Diabetes Care (2021)
Phase-3 dose-escalation RCT: 1,842 metformin-treated type 2 diabetes patients randomized to once-weekly dulaglutide 1.5, 3.0, or 4.5 mg for 52 weeks
Higher doses (3.0/4.5 mg) gave dose-related additional HbA1c reductions over the 1.5 mg reference dose
Dulaglutide as add-on treatment to SGLT2 inhibitors (with or without metformin) resulted in significant and clinically relevant improvements in glycaemic control, with acceptable tolerability that is consistent with the established safety profile of dulaglutide.
Phase-3b double-blind placebo-controlled RCT: 424 type 2 diabetes patients inadequately controlled on SGLT2 inhibitors (±metformin), randomized to dulaglutide 1.5/0.75 mg or placebo for 24 weeks
Both dulaglutide doses gave significant, clinically relevant HbA1c improvements added on top of SGLT2-inhibitor therapy
Tolerability consistent with the established dulaglutide safety profile (GI events most common)
The cognitive outcome occurred in 4.05 per 100 patient-years in participants assigned dulaglutide and 4.35 per 100 patient-years in people assigned placebo (HR 0.93, 95% CI 0.85-1.02; p=0.11). After post-hoc adjustment for individual standardised baseline scores, the hazard of substantive cognitive impairment was reduced by 14%.
Cukierman-Yaffe T, Gerstein HC, Colhoun HM, Diaz R, García-Pérez LE, Lakshmanan M, Bethel A, Xavier D, Probstfield J, Riddle MC, Rydén L, Atisso CM, Hall S, Rao-Melacini P, Basile J, Cushman WC, Franek E, Keltai M, Lanas F, Leiter LA, Lopez-Jaramillo P, Pirags V, Pogosova N, Raubenheimer PJ, Shaw JE, Sheu WH, Temelkova-Kurktschiev T, Hart R, Sharma M, Lovblom LE, Bhatt H, Cukierman-Yaffe T. · Lancet Neurol (2020)
Exploratory analysis of the REWIND trial (8,828 participants with baseline + follow-up cognitive testing) over median 5.4 years
Unadjusted cognitive-impairment outcome non-significant (HR 0.93, 95% CI 0.85-1.02; p=0.11)
After post-hoc adjustment for baseline scores, a 14% reduction in substantive cognitive impairment (HR 0.86, 95% CI 0.79-0.95; p=0.0018)
At week 26, the least squares mean change from baseline in HbA1c was greater with dulaglutide 1.5 mg (-1.67%) and dulaglutide 0.75 mg (-1.31%) compared with glargine (-1.11%)... Both doses of dulaglutide were noninferior and superior to glargine.
Li Y, Li L, De Peng Y, Song GY, Ye SD, Du LY, Hou JN, Ji QH · Diabetes Ther (2019)
Subgroup analysis of a phase-3 open-label RCT in 607 Chinese type 2 diabetes patients inadequately controlled on oral agents, randomized to dulaglutide 1.5/0.75 mg or insulin glargine
HbA1c fell more with dulaglutide 1.5 mg (-1.67%) and 0.75 mg (-1.31%) than glargine (-1.11%); both doses non-inferior and superior
Mean body weight decreased and total hypoglycemia rates were lower with dulaglutide than glargine