Primary outcome
What AWARD-JPN measured first
| Dulaglutide 1.5 mgn=383 | Dulaglutide 0.75 mgn=193 |
|---|---|
| -1.53(0.043) | -1.25(0.060) |
Phase 3 · Dulaglutide
AWARD-JPN trial results
A Randomized, Double-Blind, Parallel Arm Study of the Efficacy and Safety of Two Doses of Dulaglutide in Combination With a Single Oral Antihyperglycemic Medication or as Monotherapy in Japanese Patients With Type 2 Diabetes Mellitus (AWARD-JPN: Assessment of Weekly Administration of LY2189265 in Diabetes - JAPAN)
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 (Percentage of HbA1c), Baseline, Week 26. Dulaglutide 1.5 mg: -1.53; Dulaglutide 0.75 mg: -1.25.
- Participants
- 591
- Status
- completed
- Completed
- 2023-04-26
- Sponsor
- Eli Lilly and Company
As posted on ClinicalTrials.gov (NCT04809220), updated at source May 22, 2024. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in AWARD-JPN
Percent of participants affected, Baseline to Week 56.. The most common events the registry lists.
| Event | Dulaglutide 1.5 mg | Dulaglutide 0.75 mg |
|---|---|---|
| Any serious event | 3.8% | 3.6% |
| Constipation | 12.5% | 8.7% |
| Diarrhoea | 10.2% | 8.2% |
| Pyrexia | 10% | 7.2% |
| Nausea | 9% | 4.6% |
| Nasopharyngitis | 5.6% | 8.7% |
| Covid-19 | 7.7% | 8.2% |
| Abdominal discomfort | 6.1% | 2.6% |
| Coronavirus infection | 4.6% | 4.1% |
| Decreased appetite | 4.1% | 3.1% |
| Hyperglycaemia | 1.8% | 4.1% |
| Arthralgia | 2.3% | 4.1% |
| Headache | 3.1% | 4.1% |
| Dyspepsia | 3.6% | 3.1% |
| Malaise | 3.6% | 2.6% |
| Chronic gastritis | 1% | 3.1% |
| Lipase increased | 3.1% | 0.5% |
| Back pain | 3.1% | 2.1% |
| Eczema | 0.8% | 3.1% |
| Vomiting | 2.8% | 1% |
| Injection site reaction | 2.8% | 2.6% |
| Dental caries | 0.8% | 2.6% |
| Gastrooesophageal reflux disease | 2.6% | 1% |
| Gastroenteritis | 1.3% | 2.6% |
| Contusion | 0.8% | 2.6% |
| Dizziness | 1.5% | 2.6% |
Secondary outcomes
What else it measured
| Dulaglutide 1.5 mgn=383 | Dulaglutide 0.75 mgn=193 |
|---|---|
| -1.50(0.046) | -1.19(0.065) |
| Measure | Dulaglutide 1.5 mgn=354 | Dulaglutide 0.75 mgn=174 |
|---|---|---|
| HbA1c ≤ 6.5% | 22.88 | 21.26 |
| HbA1c < 7% | 46.33 | 38.51 |
| Dulaglutide 1.5 mgn=382 | Dulaglutide 0.75 mgn=191 |
|---|---|
| -42.4(1.47) | -33.1(2.09) |
| Measure | Dulaglutide 1.5 mgn=362 | Dulaglutide 0.75 mgn=185 |
|---|---|---|
| Morning premeal-fasting | -45.6(1.33) | -38.4(1.86) |
| Morning 2-hour post meal | -70.6(2.42) | -60.5(3.39) |
| Midday premeal | -55.3(1.77) | -47.0(2.47) |
| Midday 2-hour post meal | -73.7(2.37) | -61.2(3.32) |
| Evening premeal | -50.3(1.60) | -46.4(2.24) |
| Evening 2-hour post meal | -61.1(2.27) | -49.8(3.18) |
| Dulaglutide 1.5 mgn=383 | Dulaglutide 0.75 mgn=193 |
|---|---|
| -0.5(0.14) | -0.2(0.19) |
The trial
How AWARD-JPN was run
The purpose of this study is to evaluate the efficacy and safety of 2 doses of dulaglutide in Japanese participants with type 2 diabetes. The study duration is approximately 58 weeks.
- Dulaglutide 1.5 milligram (mg): Participants received 1.5 mg of dulaglutide given weekly subcutaneously (SC) during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 oral antihyperglycemic medication (OAM). Participants on dipeptidyl peptidase-4 inhibitors (DPP-4i) discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.
- Dulaglutide 0.75 mg: Participants received 0.75 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.
Who could join the trial
Inclusion Criteria: * Participants with type 2 diabetes (T2D) ≥ 6 months according to the World Health Organization (WHO) classification. * Treated with stable doses of a single OAM for at least 8 weeks prior to screening; the dose must be more than or equal to minimum maintenance dose. * Have the following HbA1c result at screening. * Participants taking DPP-4i: ≥7.5% and ≤9.5%, * Participants taking another OAM: ≥8.0% and ≤10.0% * Stable body weight for at least 8 weeks prior to screening or not changed by more than 5 % in the past 8 weeks * Have a body mass index (BMI) ≥18.5 kilogram/square meter (kg/m²) and \<35 kg/m² at Day 1. Exclusion Criteria: * Have type 1 diabetes (T1D) * Have a history of ≥1 episode of ketoacidosis or hyperosmolar state/coma * Have had any myocardial infarction (MI), heart failure or cerebrovascular accident (stroke) * Have a known clinically significant gastric empty abnormality * Have acute or chronic hepatitis * Have had chronic or acute pancreatitis * Have any self or family history of type 2A or type 2B multiple endocrine neoplasia in the absence of known C-cell hyperplasia * Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of Multiple endocrine neoplasia (MEN) 2A or 2B syndrome) * Have evidence of significant, active autoimmune abnormality * Have evidence of significant, uncontrolled endocrine abnormality * Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years * Have any hematologic condition that may interfere with HbA1c measurement
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.