A Phase 3 interventional study of Dulaglutide and Placebo in Type 2 Diabetes Mellitus, sponsored by Eli Lilly and Company. Completed at 27 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-24.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
The main purpose of this study is to evaluate the safety and efficacy of once weekly dulaglutide when added to insulin glargine, with metformin and/or acarbose in Chinese participants with type 2 diabetes mellitus.
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This study's enrollment of 291 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Participants received 1.5 mg Dulaglutide administered once weekly (QW) subcutaneously (SC) as add-on to titrated treat-to-target (TTT) dose of Insulin Glargine given SC, along with metformin and/or acarbose.
Drug: Dulaglutide · Drug: Insulin Glargine
Participants received placebo administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.
Drug: Placebo · Drug: Insulin Glargine
Administered SC
Also known as: LY2189265
Administered SC
Administered SC
Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c 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 + Oral Antihyperglycemic Medications (OAM) use + Treatment + Visit + Treatment\*Visit (Type III sum of squares) as variables.
Time frame: Baseline, Week 28
Percentage of Participants Achieving HbA1c <7.0%
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Odds Ratio (OR) was determined using longitudinal logistic regression model with Baseline HbA1c value + OAM use + Treatment + Visit + Treatment\*Visit as variables.
Time frame: Week 28
Change From Baseline in Body Weight
Change from baseline in body weight was reported here. LS mean was determined by MMRM model with Baseline + Baseline HbA1c strata (\<8.5%, \>=8.5%) + OAM use + Treatment + Visit + Treatment\*Visit (Type III sum of squares) as variables.
Time frame: Baseline, Week 28
Change From Baseline in Fasting Serum Glucose (FSG)
Change from baseline in FSG was reported here. LS mean was determined using MMRM model with Baseline + Baseline HbA1c strata (\<8.5%, \>=8.5%) + OAM use + Treatment + Visit + Treatment\*Visit (Type III sum of squares) as variables.
Time frame: Baseline, Week 28
Percentage of Participants Achieving HbA1c <7.0% With no Weight Gain (<0.1 kg) and Without Documented Symptomatic Hypoglycemia (Blood Glucose <3.0 mmol/L)
Percentage of Participants Achieving HbA1c \<7.0% With no Weight Gain (\<0.1 kg) and Without Documented Symptomatic Hypoglycemia (Blood Glucose \<3.0 mmol/L) was reported here.
Time frame: Week 28
Percentage of Participants Achieving HbA1c <7.0% Without Documented Symptomatic Hypoglycemia (Blood Glucose <3.0 mmol/L)
Percentage of Participants Achieving HbA1c \<7.0% Without Documented Symptomatic Hypoglycemia (Blood Glucose \<3.0 mmol/L) was reported here.
Time frame: Week 28
Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain (<0.1 kg)
Percentage of Participants Achieving HbA1c \<7.0% Without Weight Gain (\<0.1 kg) was reported here.
Time frame: Week 28
Change From Baseline in Blood Glucose From Daily Self-Monitored Blood Glucose (SMBG) Profile
The SMBG data was collected at the following 7 time points: Pre morning meal BG, 2-hour postprandial measurement for morning meal BG, Pre midday meal BG, 2-hour postprandial measurement for midday meal BG, Pre evening meal BG, 2-hour postprandial measurement for evening meals BG, and Bedtime BG. LS mean was determined using MMRM model with Baseline + OAM (metformin and/or acarbose) usage + HbA1c Group at Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Time frame: Baseline, Week 28
Change From Baseline in Daily Mean Insulin Glargine Doses
LS mean was determined using MMRM model with Baseline + Baseline HbA1c strata (\<8.5%, \>=8.5%) + OAM use + Treatment + Visit + Treatment\*Visit (Type III sum of squares) as variables.
Time frame: Baseline, Week 28
| Milestone | 1.5 Milligrams (mg) Dulaglutide | Placebo |
|---|---|---|
| Started | 144 | 147 |
| Received at least one dose of study drug | 144 | 147 |
| Completed | 134 | 142 |
| Not completed | 10 | 5 |
| Withdrew: Adverse event | 4 | 0 |
| Withdrew: Withdrawal by subject | 5 | 3 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Non-compliance with study drug | 1 | 0 |
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c 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 + Oral Antihyperglycemic Medications (OAM) use + Treatment + Visit + Treatment\*Visit (Type III sum of squares) as variables.
| Percentage of HbA1c | 1.5 mg Dulaglutide | Placebo |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) | -2.03 ± 0.076 | -1.08 ± 0.073 |
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Odds Ratio (OR) was determined using longitudinal logistic regression model with Baseline HbA1c value + OAM use + Treatment + Visit + Treatment\*Visit as variables.
| Percentage of participants | 1.5 mg Dulaglutide | Placebo |
|---|---|---|
| Percentage of Participants Achieving HbA1c <7.0% | 75.9 | 33.8 |
Change from baseline in body weight was reported here. LS mean was determined by MMRM model with Baseline + Baseline HbA1c strata (\<8.5%, \>=8.5%) + OAM use + Treatment + Visit + Treatment\*Visit (Type III sum of squares) as variables.
| kilogram (kg) | 1.5 mg Dulaglutide | Placebo |
|---|---|---|
| Change From Baseline in Body Weight | -0.76 ± 0.224 | 0.42 ± 0.217 |
Change from baseline in FSG was reported here. LS mean was determined using MMRM model with Baseline + Baseline HbA1c strata (\<8.5%, \>=8.5%) + OAM use + Treatment + Visit + Treatment\*Visit (Type III sum of squares) as variables.
| milligrams per deciliter (mg/dL) | 1.5 mg Dulaglutide | Placebo |
|---|---|---|
| Change From Baseline in Fasting Serum Glucose (FSG) | -58.47 ± 2.339 | -43.64 ± 2.269 |
Percentage of Participants Achieving HbA1c \<7.0% With no Weight Gain (\<0.1 kg) and Without Documented Symptomatic Hypoglycemia (Blood Glucose \<3.0 mmol/L) was reported here.
| Percentage of participants | 1.5 mg Dulaglutide | Placebo |
|---|---|---|
| Percentage of Participants Achieving HbA1c <7.0% With no Weight Gain (<0.1 kg) and Without Documented Symptomatic Hypoglycemia (Blood Glucose <3.0 mmol/L) | 51.8 | 21.1 |
Percentage of Participants Achieving HbA1c \<7.0% Without Documented Symptomatic Hypoglycemia (Blood Glucose \<3.0 mmol/L) was reported here.
| Percentage of participants | 1.5 mg Dulaglutide | Placebo |
|---|---|---|
| Percentage of Participants Achieving HbA1c <7.0% Without Documented Symptomatic Hypoglycemia (Blood Glucose <3.0 mmol/L) | 74.8 | 33.3 |
Percentage of Participants Achieving HbA1c \<7.0% Without Weight Gain (\<0.1 kg) was reported here.
| Percentage of participants | 1.5 mg Dulaglutide | Placebo |
|---|---|---|
| Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain (<0.1 kg) | 51.8 | 21.1 |
The SMBG data was collected at the following 7 time points: Pre morning meal BG, 2-hour postprandial measurement for morning meal BG, Pre midday meal BG, 2-hour postprandial measurement for midday meal BG, Pre evening meal BG, 2-hour postprandial measurement for evening meals BG, and Bedtime BG. LS mean was determined using MMRM model with Baseline + OAM (metformin and/or acarbose) usage + HbA1c Group at Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
| milligrams per deciliter (mg/dL) | 1.5 mg Dulaglutide | Placebo |
|---|---|---|
| Change From Baseline in Blood Glucose From Daily Self-Monitored Blood Glucose (SMBG) Profile | -64.0 ± 2.42 | -37.7 ± 2.36 |
LS mean was determined using MMRM model with Baseline + Baseline HbA1c strata (\<8.5%, \>=8.5%) + OAM use + Treatment + Visit + Treatment\*Visit (Type III sum of squares) as variables.
| International Units per day(IU/day) | 1.5 mg Dulaglutide | Placebo |
|---|---|---|
| Change From Baseline in Daily Mean Insulin Glargine Doses | 10.0 ± 1.045 | 14.0 ± 1.015 |
Collected over Baseline Through End of Safety Follow-Up (Up To 32 Weeks). Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1.5 mg Dulaglutide | 0/144 (0%) | 8/144 (5.6%) | 113/144 (78.5%) |
| Placebo | 1/147 (0.7%) | 12/147 (8.2%) | 99/147 (67.3%) |
| Event | 1.5 mg Dulaglutide | Placebo |
|---|---|---|
| Chronic gastritisGastrointestinal disorders | 0/144 | 2/147 |
| Abdominal adhesionsGastrointestinal disorders | 1/144 | 0/147 |
| Duodenal ulcer haemorrhageGastrointestinal disorders | 1/144 | 0/147 |
| Large intestine polypGastrointestinal disorders | 1/144 | 1/147 |
| Cholecystitis acuteHepatobiliary disorders | 1/144 | 0/147 |
| CholelithiasisHepatobiliary disorders | 1/144 | 0/147 |
| AppendicitisInfections and infestations | 1/144 | 0/147 |
| Diabetes mellitus inadequate controlMetabolism and nutrition disorders | 1/144 | 0/147 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 1/144 | 0/147 |
| Cerebral infarctionNervous system disorders | 1/144 | 0/147 |
| Event | 1.5 mg Dulaglutide | Placebo |
|---|---|---|
| Decreased appetiteMetabolism and nutrition disorders | 32/144 | 6/147 |
| Diabetic nephropathyRenal and urinary disorders | 20/144 | 22/147 |
| DiarrhoeaGastrointestinal disorders | 19/144 | 12/147 |
| NauseaGastrointestinal disorders | 15/144 | 8/147 |
| VomitingGastrointestinal disorders | 13/144 | 2/147 |
| Abdominal distensionGastrointestinal disorders | 11/144 | 2/147 |
| Upper respiratory tract infectionInfections and infestations | 11/144 | 10/147 |
| HyperglycaemiaMetabolism and nutrition disorders | 4/144 | 11/147 |
| HyperlipidaemiaMetabolism and nutrition disorders | 9/144 | 7/147 |
| DyspepsiaGastrointestinal disorders | 8/144 | 1/147 |
All randomized participants.
| Age, Continuous(years) | 1.5 mg Dulaglutide | Placebo | Total |
|---|---|---|---|
| Mean | 57.80 ± 9.33 | 58.30 ± 9.48 | 58.10 ± 9.39 |
| Sex: Female, Male(Participants) | 1.5 mg Dulaglutide | Placebo | Total |
|---|---|---|---|
| Female | 52 | 57 | 109 |
| Male | 92 | 90 | 182 |
| Ethnicity (NIH/OMB)(Participants) | 1.5 mg Dulaglutide | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 144 | 147 | 291 |
| Race (NIH/OMB)(Participants) | 1.5 mg Dulaglutide | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 144 | 147 | 291 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | 1.5 mg Dulaglutide | Placebo | Total |
|---|---|---|---|
| China | 144 | 147 | 291 |
| Hemoglobin A1c (HbA1c)(Percentage of HbA1c) | 1.5 mg Dulaglutide | Placebo | Total |
|---|---|---|---|
| Mean | 8.60 ± 1.00 | 8.58 ± 0.97 | 8.59 ± 0.98 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Eli Lilly and Company