Change From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand)
| Group | Value (percentage of HbA1c) | Spread |
|---|---|---|
| 1.5 mg Dulaglutide | -1.34 | 0.064 |
| 0.75 mg Dulaglutide | -1.21 | 0.064 |
| Placebo | -0.54 | 0.064 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataShort name AWARD-10
United States, Austria, Czechia, Germany, Hungary, Israel, Mexico, Puerto Rico, Spain
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 efficacy and safety of the study drug known as dulaglutide when added to sodium-glucose co-transporter 2 (SGLT2) inhibitors in participants with type 2 diabetes mellitus.
Experimental
1.5 mg Dulaglutide
1.5 milligrams (mg) given subcutaneously (SC) once a week for 24 weeks.
Experimental
0.75 mg Dulaglutide
0.75 mg dulaglutide given SC once a week for 24 weeks.
Placebo comparator
Placebo
Placebo given SC once a week for 24 weeks.
Outcomes the sponsor listed as primary.
Change From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand)
Time frame · Baseline, Week 24
Least Squares mean (LS) of the HbA1c change from baseline to primary endpoint at week 24 was adjusted by treatment, country, SGLT2 inhibitor dose, metformin use, treatment-by-visit interactions as fixed effects, and baseline HbA1c as a covariate and participant as a random effect, via a MMRM analysis. The treatment-regimen estimand used all data including post-rescue data and compared the benefit of treatment regimens as they were actually taken.
Change From Baseline in the HbA1c at 24 Weeks (Efficacy Estimand)
Time frame · Baseline, Week 24
LS mean of the HbA1c change from baseline to primary endpoint at week 24 was adjusted by treatment, country, SGLT2 inhibitor dose, metformin use, treatment-by-visit interactions as fixed effects, and baseline HbA1c as a covariate and participant as a random effect, via a MMRM analysis. The efficacy estimand excluded post-rescue data and compared the benefit of randomized treatments when taken as directed without rescue medication.
Percentage of Participants With HbA1c <7%
Time frame · 24 Weeks
Number of participants with an HbA1c value of \<7% at Week 24 is measured using longitudinal logistic regression with repeated measurements. The model will include independent variables of treatment, country, SGLT2 inhibitor dose, metformin use, visit, treatment-by-visit interaction, and baseline HbA1c as a covariate.
Change From Baseline in Body Weight at 24 Weeks
Time frame · Baseline, Week 24
LS mean of the body weight change from baseline to primary endpoint at week 24 was adjusted by treatment, country, SGLT2 inhibitor dose, metformin use, baseline HbA1c strata, treatment-by-visit interactions as fixed effects, and baseline body weight as a covariate and participant as a random effect, via a MMRM analysis
Change From Baseline in Fasting Serum Glucose (Central Laboratory) at 24 Weeks
Time frame · Baseline, Week 24
LS mean of change from baseline was calculated using last observation carried forward (LOCF) by treatment group, adjusted for treatment, country, SGLT2 inhibitor dose, metformin use, baseline HbA1c strata, and baseline fasting serum glucose using analysis of covariance (ANCOVA).
Change From Baseline in 6-Point Self-Monitored Plasma Glucose (SMPG) Profile at 24 Weeks
Time frame · Baseline, Week 24
The self-monitored plasma glucose (SMPG) data were collected at the following 6 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, metformin use, SGLT2 inhibitor use, country, visit, baseline HbA1c strata, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Change From Baseline in Fasting Glucagon at 24 Weeks
Time frame · Baseline, Week 24
Change from baseline in fasting glucagon was analyzed using an ANCOVA model with last observation carried forward (LOCF) included in treatment, country, SGLT2i dose, metformin use, and baseline HbA1c strata as fixed effects and baseline fasting glucagon as a covariate (with and without post rescue data).
Rate of Hypoglycemic Events Adjusted Per 30 Days
Time frame · Baseline through 24 Weeks
A hypoglycemic event is defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a PG level of ≤70 mg/dL (≤3.9 mmol/L).
Number of Participants Requiring Rescue Therapy Due to Severe Persistent Hyperglycemia
Time frame · Baseline through 24 Weeks
Rescue therapy was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation.
Number of Participants With Adjudicated Acute Pancreatitis Events
Time frame · Baseline through 24 Weeks
The number of participants with events of pancreatitis confirmed by adjudication were summarized cumulatively at 24 weeks. Pancreatitis events were adjudicated by a committee of physicians external to the Sponsor. A summary of serious and other non-serious events regardless of causality is located in the Reported Adverse Events module.
Number of Participants With Adjudicated Cardiovascular (CV) Events
Time frame · Baseline through 24 Weeks
Death and selected nonfatal CV adverse events (AEs) were adjudicated by an independent committee of physicians with cardiology expertise external to the Sponsor. Nonfatal CV events that were to be adjudicated were myocardial infarction (MI); hospitalization for unstable angina; hospitalization for heart failure; coronary interventions such as coronary artery bypass graft (CABG) or ( percutaneous coronary intervention (PCI); and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack (TIA).
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 | -1.34 | 0.064 |
| 0.75 mg Dulaglutide | -1.21 | 0.064 |
| Placebo | -0.54 | 0.064 |
| Group | Value (percentage of HbA1c) | Spread |
|---|---|---|
| 1.5 mg Dulaglutide | -1.33 | 0.063 |
| 0.75 mg Dulaglutide | -1.19 | 0.063 |
| Placebo | -0.51 | 0.065 |
| Group | Value (percentage of participants) |
|---|---|
| 1.5 mg Dulaglutide | 71.21 |
| 0.75 mg Dulaglutide | 60.45 |
| Placebo | 31.58 |
| Group | Value (kilograms (kg)) | Spread |
|---|---|---|
| 1.5 mg Dulaglutide | -3.1 | 0.30 |
| 0.75 mg Dulaglutide | -2.6 | 0.30 |
| Placebo | -2.1 | 0.30 |
| Group | Value (milligram/deciliter (mg/dL)) | Spread |
|---|---|---|
| 1.5 mg Dulaglutide | -31.6 | 2.17 |
| 0.75 mg Dulaglutide | -26.5 | 2.18 |
| Placebo | -6.9 | 2.21 |
| Group | Value (mg/dL) | Spread |
|---|---|---|
| 1.5 mg Dulaglutide | -27.8 | 2.13 |
| 0.75 mg Dulaglutide | -23.2 | 2.17 |
| Placebo | -8.1 | 2.14 |
| Group | Value (picomole per liter (pmol/L)) | Spread |
|---|---|---|
| 1.5 mg Dulaglutide | -2.1 | 0.39 |
| 0.75 mg Dulaglutide | -1.5 | 0.39 |
| Placebo | -0.9 | 0.40 |
| Group | Value (Number of events/participant/30 days) | Spread |
|---|---|---|
| 1.5 mg Dulaglutide | 0.026 | 0.1827 |
| 0.75 mg Dulaglutide | 0.022 | 0.1375 |
| Placebo | 0.017 | 0.1320 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| 1.5 mg DulaglutideDulaglutide 1.5 milligrams (mg) given SC QW for 24 weeks. | 2 / 142 | 5 / 142 | 43 / 142 |
| 0.75 mg DulaglutideDulaglutide 0.75 mg given subcutaneously (SC) once a week (QW) for 24 weeks. | 0 / 141 | 3 / 141 | 34 / 141 |
| PlaceboPlacebo given SC QW for 24 weeks. | 0 / 140 | 5 / 140 | 29 / 140 |
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
Studies that cite this trial.
2 studies on this page
Indexing hint: Meta-analysis (pooled) · 2023
Ferdinand et al. 2023Cardiovascular diabetologycited by 12
PMID 36894938PMC9999488DOI 10.1186/s12933-023-01775-xPUB-36894938
Indexing hint: Randomized controlled trial · 2018
Ludvik et al. 2018The lancet. Diabetes & endocrinologycited by 205
PMID 29483060DOI 10.1016/s2213-8587(18)30023-8PUB-29483060
Who could join, as posted.
PepBank is a research reference. Talk to a doctor before you use any peptide.
In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated