Dulaglutide: research
A weekly GLP-1 medicine approved for type 2 diabetes and lower heart-event risk.
Also called: Trulicity, LY2189265.
GLP-1 / GIP / glucagon agonists · GLP-1 receptor agonist · Evidence: Approved drug.
117 registered interventional records found before the cutoff, including planned trials and comparator arms. Selected major reports appear below; this is not a completed-trial count.
Studies
- EGO: early weekly dose steps. rct, n=262, Adults with type 2 diabetes taking two oral medicines. 0.5→1 mg −1.38%; 1 mg −1.32%; 1→2 mg −1.59%; placebo −0.24%. (source)
- Early weekly monotherapy. rct, n=167, Adults with type 2 diabetes, without other glucose-lowering drugs. 0.5/1/1.5 mg: −0.9/−1.0/−1.0%; placebo 0.0%. The abstract does not give the 0.1 mg HbA1c result. (source)
- AWARD-5: seven-dose selection. rct, Adults with type 2 diabetes on metformin. 1.5 mg was selected as optimal; 0.75 mg was the second selected dose. (source)
- Higher doses: 1.5, 3 and 4.5 mg. rct, n=318, Adults with type 2 diabetes on metformin ≥1500 mg/day. 1.5/3/4.5 mg: −1.23/−1.31/−1.40%; placebo −0.44%. (source)
- AWARD-1: metformin plus pioglitazone. rct, n=978, Adults with type 2 diabetes on metformin and pioglitazone. 1.5 mg −1.51%; 0.75 mg −1.30%; exenatide −0.99%; placebo −0.46%. (source)
- AWARD-2: versus basal insulin. rct, n=810, Adults with type 2 diabetes on metformin and glimepiride. 1.5 mg −1.08%; 0.75 mg −0.76%; glargine −0.63%. (source)
- AWARD-3: monotherapy. rct, n=807, Adults with early type 2 diabetes. 1.5 mg −0.78%; 0.75 mg −0.71%; metformin −0.56%. (source)
- AWARD-4: with mealtime insulin. rct, n=884, Adults with type 2 diabetes needing insulin lispro. 1.5 mg −1.64%; 0.75 mg −1.59%; glargine −1.41%. (source)
- AWARD-5: versus sitagliptin. rct, n=1098, Adults with type 2 diabetes taking metformin. 1.5 mg −1.10%; 0.75 mg −0.87%; sitagliptin −0.39%; no continuing placebo arm. (source)
- AWARD-6: versus liraglutide. rct, n=599, Adults with type 2 diabetes taking metformin ≥1500 mg/day. Dulaglutide −1.42%; liraglutide −1.36%; met the noninferiority criterion. (source)
- AWARD-7: chronic kidney disease. rct, n=577, Adults with type 2 diabetes and stage 3–4 kidney disease; all used lispro. Changes −1.2%, −1.1% and −1.1% for 1.5 mg, 0.75 mg and glargine. (source)
- AWARD-8: added to glimepiride. rct, n=300, Adults with type 2 diabetes taking glimepiride. Between-group difference −1.3 percentage points, 95% CI −1.6 to −1.0. (source)
- AWARD-9: added to insulin glargine. rct, n=300, Adults with type 2 diabetes taking titrated basal insulin. −1.44% versus −0.67%. (source)
- AWARD-10: added to an SGLT2 drug. rct, n=424, Adults with type 2 diabetes on an SGLT2 inhibitor, with or without metformin. 1.5 mg −1.34%; 0.75 mg −1.21%; placebo −0.54%. (source)
- AWARD-11: 1.5, 3 or 4.5 mg. rct, n=1842, Adults with type 2 diabetes on metformin. 4.5 mg −1.77% versus 1.5 mg −1.54%; 3 mg difference versus 1.5 mg −0.10 points, P=0.096. (source)
- REWIND: heart outcomes. rct, n=9901, Adults ≥50 with type 2 diabetes and prior events or cardiovascular risk factors. 594/4949 or 12.0% versus 663/4952 or 13.4%; HR 0.88, 95% CI 0.79–0.99. (source)
- REWIND: kidney outcomes. rct, n=9901, Same REWIND randomized population. 17.1% versus 19.6%; HR 0.85, 95% CI 0.77–0.93. (source)
- AWARD-PEDS: youth diabetes. rct, n=154, Ages 10 to <18 with type 2 diabetes. 0.75 mg −0.6 points; 1.5 mg −0.9 points; placebo +0.6 points. (source)
- AWARD-CHN1: East Asian monotherapy. rct, n=737, East Asian adults with type 2 diabetes. 1.5 mg difference −0.58 points; 0.75 mg −0.32 points. (source)
- AWARD-CHN2: Chinese subgroup. rct, n=607, Chinese adults with type 2 diabetes taking 1–2 oral medicines. 1.5 mg −1.67%; 0.75 mg −1.31%; glargine −1.11%. (source)
- AWARD-CHN3: added to basal insulin. rct, n=291, Chinese adults on insulin glargine with metformin and/or acarbose. −2.0% versus −1.1%; published adjusted difference −1.0 percentage point. (source)
- AWARD-JPN: Japanese dose comparison. rct, n=591, Japanese adults with type 2 diabetes. 1.5 versus 0.75 mg difference −0.29 points, 95% CI −0.43 to −0.14. (source)
- SURPASS-CVOT: versus tirzepatide. rct, n=13299, Adults with type 2 diabetes and established atherosclerotic disease. Dulaglutide 862/6579 or 13.1%; tirzepatide 801/6586 or 12.2%; tirzepatide HR 0.92, 95.3% CI 0.83–1.01. (source)
- Class evidence: heart and kidney outcomes. meta-analysis, n=85373, Participants in 11 large randomized GLP-1 trials. HR 0.87, 95% CI 0.81–0.93 versus placebo. (source)
- Class evidence: gallbladder harms. meta-analysis, n=103371, Participants in 76 randomized GLP-1 trials. RR 1.37, 95% CI 1.23–1.52; higher risk in weight-loss trials, RR 2.29. (source)
- Thyroid cancer: Scandinavian cohort. cohort, n=437077, 145,410 GLP-1 initiators versus 291,667 DPP-4 initiators. 76 versus 184 cases; HR 0.93, 95% CI 0.66–1.31. (source)
- Poison-center reports: dosing harm. cohort, n=13924, Single-substance GLP-1 exposures reported to US poison centers. 91.7% had no or mild effects; 8.0% had moderate effects, 42 had major effects, and two died. (source)
- AWARD-CHN2: mainly Asian cohort. rct, n=774, Adults from China, South Korea, Mexico and Russia on metformin and/or sulfonylurea. 1.5 mg −1.73%; 0.75 mg −1.33%; glargine −1.16%. (source)
- Japanese monotherapy phase 3. rct, n=492, Japanese adults with type 2 diabetes, age ≥20. Dulaglutide–placebo difference −1.57 points; dulaglutide–liraglutide difference −0.10 points. (source)
- Japanese dulaglutide versus glargine. rct, n=361, Japanese adults taking sulfonylurea and/or biguanide. Dulaglutide −1.44%; glargine −0.90%. (source)
Dulaglutide dosage
Typical reported dose: 0.75 mg once a week to start, up to 4.5 mg
- Trulicity: adult label only: 0.75 mg once weekly, then 1.5 mg once weekly, if needed, then 3 mg once weekly, if needed, then 4.5 mg once weekly, if needed once weekly, under the skin. Drug label. Studied in: Adults with type 2 diabetes. (source)
- Early trial: 0.1 mg weekly: 0.1 mg once weekly; fixed assigned dose. once weekly, under the skin. Studied in a trial. Studied in: Adults with type 2 diabetes on no other glucose medicine. (source)
- Early trial: 0.5 mg weekly: 0.5 mg once weekly; fixed assigned dose. once weekly, under the skin. Studied in a trial. Studied in: Adults with type 2 diabetes on no other glucose medicine. (source)
- Early trial: 1 mg weekly: 1 mg once weekly; fixed assigned dose. once weekly, under the skin. Studied in a trial. Studied in: Adults with type 2 diabetes on no other glucose medicine. (source)
- Early trial: 1.5 mg weekly: 1.5 mg once weekly; fixed assigned dose. once weekly, under the skin. Studied in a trial. Studied in: Adults with type 2 diabetes on no other glucose medicine. (source)
- EGO: 0.5 to 1: 0.5 mg once weekly, then 1 mg once weekly once weekly, under the skin. Studied in a trial. Studied in: Adults with type 2 diabetes taking two oral drugs. (source)
These are doses reported in labels, trials or user reports, not a personal plan. Check the source behind each one.
Dulaglutide side effects and risks
Reported side effects
- Nausea: 0.75/1.5 mg: 12.4/21.1%; placebo 5.3%., moderate. Review persistent symptoms before increasing the dose; vomiting may cause dehydration. (source)
- Diarrhea: 0.75/1.5 mg: 8.9/12.6%; placebo 6.7%., moderate. Review persistent symptoms before increasing the dose; vomiting may cause dehydration. (source)
- Vomiting: 0.75/1.5 mg: 6.0/12.7%; placebo 2.3%., moderate. Review persistent symptoms before increasing the dose; vomiting may cause dehydration. (source)
- Abdominal pain: 0.75/1.5 mg: 6.5/9.4%; placebo 4.9%., moderate. Review persistent symptoms before increasing the dose; vomiting may cause dehydration. (source)
- Pancreatitis: In the high dose study: 1.5 mg 0.2%, 3 mg 0.3%, 4.5 mg 0.5%; rare severe cases reported., serious (source)
- Diabetic eye complications: REWIND: 1.9% versus placebo 1.5%; with prior retinopathy, 8.5% versus 6.2%., serious. Monitor existing diabetic retinopathy, especially during rapid glucose improvement. (source)
- Gallbladder disease: REWIND gallstones: 0.62 versus 0.56 events/100 patient years, adjusted for prior gallbladder removal., serious (source)
- Low blood sugar with insulin or sulfonylureas: AWARD 9 with basal insulin: 7.69 versus placebo 8.56 events/patient/year; one severe episode with dulaglutide., serious (source)
- Kidney injury from dehydration: Postmarketing cases, sometimes requiring dialysis; no reliable frequency., serious (source)
- Severe allergic reaction: Anaphylaxis and angioedema are reported; no reliable frequency., serious (source)
- Thyroid C-cell tumors: Rodent finding; whether dulaglutide causes these tumors in humans is unknown., serious (source)
Stop and get help if
- Severe, persistent belly pain, especially spreading to the back: Stop the drug and seek urgent care for possible pancreatitis.
- Face or throat swelling, trouble breathing, or collapse: Call emergency services now; do not take another dose.
- Confusion, seizure, fainting or low blood sugar that does not resolve: Get emergency care. If awake and able to swallow, use fast sugar while help is arranged.
- Repeated vomiting, inability to keep fluids down, or very little urine: Seek urgent assessment for dehydration and kidney injury.
- Upper-right belly pain with fever, yellow skin or pale stools: Seek urgent care for possible gallbladder or bile-duct disease.
- Sudden vision loss or a major new change in vision: Get urgent same-day eye or emergency assessment.
- Chest pain, marked breathlessness or fainting: Call emergency services now.
Who should avoid it
- pregnant: Weight loss is unsuitable; fetal-risk data are limited and animal findings raise concern.
- tryingToConceive: Review a stopping plan before conception; no safe conception interval was established in the extracted sources.
- breastfeeding: Human milk and infant-safety data are inadequate.
- under18: Some labeled diabetes or obesity uses include children; this is not a blanket pediatric label ban.
- mtcOrMen2: Personal or family medullary thyroid cancer or MEN2 is a label contraindication for this GLP-1 product.
- other: Do not re-expose after a serious allergic reaction to the drug or its ingredients.
- pancreatitisHistory: Past pancreatitis needs review; stop and urgently assess persistent severe abdominal pain.
- gallbladderDisease: Gallstones or previous gallbladder inflammation increase the need to assess new upper-abdominal pain.
- gastroparesis: Severe gastroparesis is a label reason to avoid use; these medicines further slow stomach emptying.
- eatingDisorderHistory: Listed as a reason to avoid it.
- kidneyDisease: Kidney function and hydration need review, especially with vomiting or diarrhea.
- liverDisease: Clinical experience in severe liver impairment is limited; review the specific product and other medicines.
- diabeticRetinopathy: Rapid glucose improvement can temporarily worsen diabetic eye disease; arrange appropriate eye follow-up.
- surgeryPlanned: Tell the anesthesia team. Delayed stomach emptying can leave food in the stomach despite fasting.
- diabetes: Review glucose monitoring and insulin or sulfonylurea doses. Do not rapidly stop insulin.
Interactions
- Insulin: Low blood sugar risk can rise. Insulin adjustment needs glucose readings; rapid withdrawal can cause ketoacidosis.
- Sulfonylureas and related insulin-releasing drugs: Low blood sugar can increase; a clinician may need to lower the companion drug dose.
- Another GLP-1 or GLP-1/GIP medicine: Avoid duplicate incretin therapy. Switching guidance stops the previous product rather than stacking both.
- DPP-4 inhibitors: Routine combination is not recommended because it adds little glucose benefit over GLP-1 therapy alone.
- Time-sensitive oral medicines: Slower stomach emptying can alter absorption timing; the effect is medicine-specific. Review critical oral drugs, especially with vomiting or poor intake.
- Warfarin: Monitor INR with initiation or changes; the label advises caution with narrow-therapeutic-index oral drugs.
Product quality risks
- Online GLP-1 products can contain the wrong amount, a different drug or contamination. A seller’s purity claim does not establish sterile injectable quality.
- Three online semaglutide vials had 28.56–38.69% excess drug and endotoxin. Those samples were not this compound.
- No direct laboratory survey of online dulaglutide products was found; semaglutide assay rates cannot be assigned to dulaglutide.
How Dulaglutide works
It copies a gut hormone that helps you feel full. It increases insulin release when blood sugar is high, lowers glucagon, and slows food leaving the stomach.
- GLP-1 receptor: Increases glucose-dependent insulin release, lowers glucagon and slows stomach emptying.
Half-life: About 5 days.
Gaps: Registered-study count includes planned studies and comparator arms, not 117 completed trials. Microdosing and cycling lack controlled evidence; a published shortage guide describes multiple weekly injections, but spaced-dose trial support was not verified. Early phase 2 and regional initiation details are incomplete where noted; later schedules were not substituted. No direct assay survey of online dulaglutide or validated home-reconstitution stability was found. Rare harms and long-term outcomes at 3 or 4.5 mg are less certain than at 1.5 mg. Schema has no not-applicable compounding category for biologics; the text states the 503A/503B exclusion.
Related to Dulaglutide
- Semaglutide: A GLP-1 medicine with strong weight, glucose, heart and kidney evidence; dose and formulation matter.
- Tirzepatide: A weekly GIP/GLP-1 injection with strong diabetes and weight-loss evidence and common stomach side effects.
- Retatrutide: An experimental weekly injection with phase 3 weight-loss results.
- Liraglutide: A daily GLP-1 injection approved for weight management and type 2 diabetes.
- Exenatide: An older GLP-1 with twice-daily and weekly forms, now widely discontinued.
Dulaglutide: the short version
Sources
- 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2026, 2026
- Compounding and the FDA: Questions and Answers, FDA · FDA · 2026
- Consensus-based clinical and research recommendations for use of glucagon-like peptide-1 receptor agonists in the context of eating disorders: a modified Delphi study., Keshen A et al. · World psychiatry : official journal of the World Psychiatric Association (WPA) · 2026
- GLP-1 receptor agonists and dual GLP-1/GIP receptor agonists: strengthened warnings on acute pancreatitis, including necrotising and fatal cases, 2026
- The 2026 Monitoring Program, World Anti-Doping Agency · 2026
- Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026, Australian Government · Australian Government · 2026
- TRULICITY, 2026
- Trulicity: pediatric type 2 diabetes, age 10+ — prescribing information, sections 1 and 2, DailyMed · 2026
- Weight Loss Drugs: What athletes need to know about GLP-1s, USADA · 2026
- Nutritional priorities to support GLP-1 therapy for obesity: A joint advisory from the American College of Lifestyle Medicine, the American Society for Nutrition, the Obesity Medicine Association, and the Obesity Society., Mozaffarian D et al. · Obesity pillars · 2025
- GLP-1 receptor agonists: reports of diabetic ketoacidosis when concomitant insulin was rapidly reduced or discontinued, 2019
- Product information
- Trulicity | European Medicines Agency (EMA)
- Comparison of Pediatric and Adult Glucagon-Like Peptide-1 Receptor Agonist Exposures Reported To United States Poison Centers, 2017-2024., Senthilkumar A et al. · Journal of medical toxicology : official journal of the American College of Medical Toxicology · 2026
- Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes., Nicholls SJ et al. · The New England journal of medicine · 2025
Sources checked: 2026-10-18.
Information only, not medical advice. Peptifacts does not sell anything and does not link to sellers.