Primary outcomeLeast squares mean· Baseline, Week 26
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26
| Group | Value (Percentage of HbA1c) | Spread |
|---|---|---|
| Dulaglutide 1.5 mg | -1.53 | 0.043 |
| Dulaglutide 0.75 mg | -1.25 | 0.060 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataA Study of Two Doses of Dulaglutide (LY2189265) in Japanese Patients With Type 2 Diabetes
Short name AWARD-JPN
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 591 participants (actual)
- Sponsor
- Eli Lilly and Company · Industry
- Design
- Randomized · Double masking
- Countries
1 country
Japan
- Start
- 13 Apr 2021
- Primary completion
- 1 Oct 2022
- Completion
- 26 Apr 2023
- First posted
- 22 Mar 2021
- Last update posted
- 22 May 2024
- Conditions
- Diabetes Mellitus · Diabetes Mellitus, Type 2 · Glucose Metabolism Disorders · Metabolic Disease · Endocrine System Diseases · Hypoglycemic Agents · Type 2 Diabetes Mellitus (T2DM)
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2021202220232024
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- DulaglutideDrug
- Oral antihyperglycemicsDrug
Arms2
Experimental
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.
Active comparator
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26
Time frame · Baseline, Week 26
Registry description
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Pre-study oral antihyperglycemic medication (OAM) Group 1 + Treatment + Time + Treatment × Time as variables.
Secondary outcomes(5)
Change From Baseline in HbA1c at Week 52
Time frame · Baseline, Week 52
Registry description
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model with Baseline + Pre-study OAM Group 1 + Treatment + Time + Treatment × Time as variables.
Percentage of Participants Achieving HbA1c Target ≤6.5% and <7.0%
Time frame · Week 52
Registry description
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The odds ratios, confidence intervals, and p-values were determined by generalized linear mixed model (GLM) with Baseline + Pre-study OAM Group 1 + Treatment + Time + Treatment × Time as variables.
Change From Baseline in Fasting Serum Glucose (FSG)
Time frame · Baseline, Week 52
Registry description
FSG is a test to determine sugar levels in serum sample after an overnight fast. LS mean was determined by MMRM model with Baseline + Baseline HbA1c (High, Low) Group, OAM-based + Pre-study OAM Group 1 + Treatment + Time + Treatment\*Time as variables.
Change From Baseline in 6-point Self-Monitored Blood Glucose (SMBG)
Time frame · Baseline, Week 26
Registry description
SMBG 6-point profiles were measured at morning (premeal-fasting, 2-hour post meal), midday (premeal, 2-hour post meal), and evening (premeal, 2-hour post meal). LS mean was determined by analysis of covariance (ANCOVA) model with Baseline + Baseline HbA1c (High, Low) Group, OAM-based + Pre-study OAM Group 1 + Treatment as variables.
Change From Baseline in Body Weight
Time frame · Baseline, Week 52
Registry description
LS mean was determined by MMRM model with Baseline + Baseline HbA1c (High, Low) Group, OAM-based + Pre-study OAM Group 1 + Treatment + Time + Treatment\*Time as variables.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(5)
Secondary outcomeLeast squares mean· Baseline, Week 52
Change From Baseline in HbA1c at Week 52
| Group | Value (Percentage of HbA1c) | Spread |
|---|---|---|
| Dulaglutide 1.5 mg | -1.50 | 0.046 |
| Dulaglutide 0.75 mg | -1.19 | 0.065 |
Secondary outcomeNumber· Week 52
Percentage of Participants Achieving HbA1c Target ≤6.5% and <7.0%
| Group | Value (Percentage of participants) |
|---|---|
| Dulaglutide 1.5 mg | 22.88 |
| Dulaglutide 0.75 mg | 21.26 |
Secondary outcomeLeast squares mean· Baseline, Week 52
Change From Baseline in Fasting Serum Glucose (FSG)
| Group | Value (milligrams per deciliter (mg/dL)) | Spread |
|---|---|---|
| Dulaglutide 1.5 mg | -42.4 | 1.47 |
| Dulaglutide 0.75 mg | -33.1 | 2.09 |
Secondary outcomeLeast squares mean· Baseline, Week 26
Change From Baseline in 6-point Self-Monitored Blood Glucose (SMBG)
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Dulaglutide 1.5 mg | -45.6 | 1.33 |
| Dulaglutide 0.75 mg | -38.4 | 1.86 |
Secondary outcomeLeast squares mean· Baseline, Week 52
Change From Baseline in Body Weight
| Group | Value (kilogram (kg)) | Spread |
|---|---|---|
| Dulaglutide 1.5 mg | -0.5 | 0.14 |
| Dulaglutide 0.75 mg | -0.2 | 0.19 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Dulaglutide 1.5 mgParticipants received 1.5 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. | 1 / 391 | 15 / 391 | 298 / 391 |
| Dulaglutide 0.75 mgParticipants 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. | 0 / 195 | 7 / 195 | 143 / 195 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 20 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
PepBank is a research reference. Talk to a doctor before you use any peptide.