Change From Baseline in Hemoglobin A1c (HbA1c)
| Group | Value (Percentage of HbA1c) | Spread |
|---|---|---|
| 1.5 mg Dulaglutide | -2.03 | 0.076 |
| Placebo | -1.08 | 0.073 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataShort name AWARD-CHN3
China
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Experimental
1.5 Milligrams (mg) Dulaglutide
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.
Placebo comparator
Placebo
Participants received placebo administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.
Outcomes the sponsor listed as primary.
Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame · Baseline, Week 28
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 Participants Achieving HbA1c <7.0%
Time frame · Week 28
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.
Change From Baseline in Body Weight
Time frame · Baseline, Week 28
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.
Change From Baseline in Fasting Serum Glucose (FSG)
Time frame · Baseline, Week 28
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.
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)
Time frame · 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) was reported here.
Percentage of Participants Achieving HbA1c <7.0% Without Documented Symptomatic Hypoglycemia (Blood Glucose <3.0 mmol/L)
Time frame · Week 28
Percentage of Participants Achieving HbA1c \<7.0% Without Documented Symptomatic Hypoglycemia (Blood Glucose \<3.0 mmol/L) was reported here.
Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain (<0.1 kg)
Time frame · Week 28
Percentage of Participants Achieving HbA1c \<7.0% Without Weight Gain (\<0.1 kg) was reported here.
Change From Baseline in Blood Glucose From Daily Self-Monitored Blood Glucose (SMBG) Profile
Time frame · Baseline, Week 28
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.
Change From Baseline in Daily Mean Insulin Glargine Doses
Time frame · Baseline, Week 28
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Percentage of HbA1c) | Spread |
|---|---|---|
| 1.5 mg Dulaglutide | -2.03 | 0.076 |
| Placebo | -1.08 | 0.073 |
| Group | Value (Percentage of participants) |
|---|---|
| 1.5 mg Dulaglutide | 75.9 |
| Placebo | 33.8 |
| Group | Value (kilogram (kg)) | Spread |
|---|---|---|
| 1.5 mg Dulaglutide | -0.76 | 0.224 |
| Placebo | 0.42 | 0.217 |
| Group | Value (milligrams per deciliter (mg/dL)) | Spread |
|---|---|---|
| 1.5 mg Dulaglutide | -58.47 | 2.339 |
| Placebo | -43.64 | 2.269 |
| Group | Value (Percentage of participants) |
|---|---|
| 1.5 mg Dulaglutide | 51.8 |
| Placebo | 21.1 |
| Group | Value (Percentage of participants) |
|---|---|
| 1.5 mg Dulaglutide | 74.8 |
| Placebo | 33.3 |
| Group | Value (Percentage of participants) |
|---|---|
| 1.5 mg Dulaglutide | 51.8 |
| Placebo | 21.1 |
| Group | Value (milligrams per deciliter (mg/dL)) | Spread |
|---|---|---|
| 1.5 mg Dulaglutide | -64.0 | 2.42 |
| Placebo | -37.7 | 2.36 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| 1.5 mg DulaglutideParticipants received 1.5 mg Dulaglutide administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose. | 0 / 144 | 8 / 144 | 113 / 144 |
| PlaceboParticipants received placebo administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose. | 1 / 147 | 12 / 147 | 99 / 147 |
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