
Dulaglutide dosage
Dosing as the FDA label states it, how long trials ran, and the arithmetic for working with vials.
- Regulatory status
- FDA-approved
- Human amounts
- Adults: 0.75 mg once weekly to start; may increase to 1.5 mg after 4 weeks, then in 1.5 mg steps after at least 4 weeks; maximum 4.5 mg once weekly. Pediatric (10 years and older): 0.75 mg, maximum 1.5 mg once weekly
- Route studied
- Subcutaneous injection
- Frequency
- Once weekly
- Half-life
- Approximately 5 days
- Evidence grade
- Grade A · Human trial evidence
- Vial sizes on the market
- Not recorded
- Other forms seen
- —
What Dulaglutide is
Dulaglutide is a once-weekly GLP-1 receptor agonist fusion protein, FDA-approved as Trulicity for glycemic control in type 2 diabetes (adults and children 10 years and older) and for reducing major adverse cardiovascular events in adults with type 2 diabetes.
Dulaglutide activates the GLP-1 receptor, a cell-surface receptor coupled to adenylyl cyclase in pancreatic beta cells, increasing intracellular cAMP and glucose-dependent insulin release 1. Pharmacodynamics It decreases glucagon secretion and slows gastric emptying; the delay in gastric emptying is largest after the first dose and diminishes with later doses 1. Both first- and second-phase insulin secretion… How it works →
Key evidence
- Gerstein et al., Lancet (REWIND, NCT01394952) · 2019 · Humans (9,901 adults aged 50 or older with type 2 diabetes and prior CV disease or risk factors)
- Frias et al., Diabetes Care (AWARD-11, NCT03495102) · 2021 · Humans (1,842 adults with type 2 diabetes on metformin)
- Arslanian et al., N Engl J Med (AWARD-PEDS, NCT02963766) · 2022 · Humans (154 youths aged 10 to under 18 with type 2 diabetes)
Schedules by time period
Label regimens and laid out week by week. Each bar is what the label states or what investigators gave participants; none is a recommendation.
Week-by-week table
| Period | Amount |
|---|---|
| Weeks 0–4 | 0.75 mg |
| Weeks 4–onward | 1.5 mg (maintenance) |
Maximum 4.5 mg once weekly.
Week-by-week table
| Period | Amount |
|---|---|
| Weeks 0–4 | 0.75 mg |
| Weeks 4–onward | 1.5 mg (maintenance) |
Maximum 1.5 mg once weekly.
Escalation beyond 0.75 mg is optional and based on glycemic need; each step requires at least 4 weeks on the current dosage.
Dosing as stated on the FDA label
- Adults: the recommended starting dosage is 0.75 mg subcutaneously once weekly; after 4 weeks it may be increased to 1.5 mg once weekly for additional glycemic control, and further in 1.5 mg increments after at least 4 weeks on the current dosage, to a maximum of 4.5 mg once weekly 1.
- Pediatric patients 10 years and older: starting dosage 0.75 mg once weekly; if needed, increase to the maximum of 1.5 mg once weekly after at least 4 weeks 1.
- Missed dose: give as soon as possible if at least 3 days (72 hours) remain until the next scheduled dose; otherwise skip it 1.
- Administration and preparation instructions are set out in the prescribing information and are not reproduced here 1.
How long did human studies run?
No human study durations are recorded for Dulaglutide.
Cycle-length evidence for DulaglutideSide effects reported in studies
- Nausea12.4% (0.75 mg) and 21.1% (1.5 mg) versus 5.3% placebo · Pool of placebo-controlled adult trials (n=1,670 exposed, mean 23.8 weeks) 1
- Diarrhea8.9% and 12.6% versus 6.7% · Same pool 1
- Vomiting6.0% and 12.7% versus 2.3% · Same pool 1
- Abdominal pain6.5% and 9.4% versus 4.9% · Same pool 1
- Decreased appetite4.9% and 8.6% versus 1.6% · Same pool 1
- Dyspepsia4.1% and 5.8% versus 2.3% · Same pool 1
- Fatigue4.2% and 5.6% versus 2.6% · Same pool 1
- Sinus tachycardia2.8% and 5.6% versus 3.0% · Placebo-controlled adult trials 1
Supplies and handling
- Lyophilized vialSealed vial with the freeze-dried cake. Check the label, lot and the certificate of analysis before opening.
- Sterile diluentThe diluent named on the product documentation. Bacteriostatic water contains benzyl alcohol; sterile water does not.
- Graduated syringesSized to the volume being measured. U-100 insulin syringes are graduated in units where 100 units = 1 mL.
- Alcohol prep padsFor wiping vial stoppers before each puncture.
- Nitrile glovesClean gloves for aseptic handling.
- Sharps containerPuncture-resistant container for used needles.
Storage
The label directs refrigerated storage (2 to 8°C) in the original carton, protected from light and not frozen; a pen may be kept at room temperature up to 30°C for a total of 14 days 1.
- Lyophilized (unmixed) vials: typically stored cold and dry, away from light, as the documentation directs. Many are stable longer frozen.
- Reconstituted vials: typically refrigerated (about 2–8 °C), protected from light and not frozen.
- Bacteriostatic water contains benzyl alcohol, which inhibits bacterial growth in multi-use vials; sterile water has no preservative.
Handling mistakes and troubleshooting
- Added the wrong volume of diluent
- The concentration changes, not the amount of compound in the vial. Recalculate with the volume actually added and relabel the vial.
- Shook the vial and it foamed
- Let it settle in the refrigerator. Foam is a sign of agitation; some peptides aggregate when shaken. Note it on the label.
- The solution is cloudy or has particles
- Do not use it. Cloudiness can indicate incomplete dissolution, contamination or degradation. Record the lot and contact the supplier with the certificate of analysis.
- The powder cake looks melted or shrunken before reconstitution
- This can indicate the vial was exposed to heat or moisture. Record the lot and condition on arrival.
- Liquid sprayed back when the needle was removed
- Pressure built up in the vial. Withdraw a small volume of air while adding diluent to keep pressure neutral.
Regulatory status
- Status
- FDA-approved (initial U.S. approval 2014) as Trulicity, BLA 125469, listed with prescription marketing status as of 2026-10-24 1,5.
- United States (FDA)
- FDA-approved (initial U.S. approval 2014) under BLA 125469 as Trulicity; Drugs@FDA lists the products with prescription marketing status as of 2026-10-24 1,5.
- Sport (WADA)
- GLP-1 receptor agonists, including dulaglutide, were not mentioned on the WADA 2026 Prohibited List page reviewed 6.
Status varies by country and changes over time. How we describe regulatory status.
Dulaglutide compared with related compounds
| Compound | Status | Evidence | Human amounts | Half-life |
|---|---|---|---|---|
| Dulaglutide | FDA-approved | A | FDA label | Approximately 5 days |
| Mazdutide | Approved outside the US | A | Trial doses | 150.9 to 403.5 hours (phase 1b in overwe |
| Ecnoglutide | Approved outside the US | A | Trial doses | 124 to 138 hours at steady state in heal |
| Vesugen | Not approved — research use only | C | None established | — |
| Tesofensine | Investigational | B | Trial doses | About 234 hours (M1 metabolite about 374 |
| Cagrilintide | Investigational | A | Trial doses | 159 to 195 hours (phase 1b, co-administe |
Frequently asked questions
What doses of Dulaglutide have been studied in humans?
Is there an established Dulaglutide cycle length?
How much bacteriostatic water should be added to a Dulaglutide vial?
How many units is a given amount on an insulin syringe?
What is the half-life of Dulaglutide?
References
- TRULICITY (dulaglutide) injection, for subcutaneous use, prescribing information (DailyMed, effective 06/2026) FDA label (DailyMed). 2026
- Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial Lancet. 2019
- Efficacy and Safety of Dulaglutide 3.0 mg and 4.5 mg Versus Dulaglutide 1.5 mg in Metformin-Treated Patients With Type 2 Diabetes in a Randomized Controlled Trial (AWARD-11) Diabetes Care. 2021
- Once-Weekly Dulaglutide for the Treatment of Youths with Type 2 Diabetes N Engl J Med. 2022
- Drugs@FDA (openFDA) application record BLA125469, TRULICITY U.S. FDA. 2026
- World Anti-Doping Agency Prohibited List 2026 (online version) WADA. 2026
Last reviewed October 24, 2026 by the Amiravo editorial team. Editorial policy · Report an error