LivingGLP1
Study S001064

The Efficacy and Safety of Once-Weekly, Subcutaneous Dulaglutide Monotherapy Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus

Registration

Registration
NCT01644500
Acronym
AWARD-CHN1
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
TRIPLE
Status
COMPLETED
Enrollment
737
Start
2012-07
Primary completion
2014-08
Lead sponsor
Eli Lilly and Company
Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG:Dulaglutide; DRUG:Glimepiride; DRUG:Placebo as Capsules; DRUG:Placebo as SC Injection
Results posted
TRUE
Individual participant data sharing
YES
Secondary identifiers
OTHER:H9X-JE-GBCG

Registered primary outcomes

  • Change From Baseline in HbA1c at 26 Weeks [Baseline, 26 Weeks]

Linked records (9)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0019392Evaluation of Characteristics of Gastrointestinal Adverse Events with Once-Weekly Dulaglutide Treatment in Chinese Patients with Type 2 Diabetes: A Post Hoc Pooled Analysis of Two Randomized Trials.
Guo L, Diabetes therapy : research, treatment and education of diabetes and related disorders
2020Randomized trialPMID 32621083DOIcites ClinicalTrials.gov:NCT01644500; registry reference DERIVED:32621083
R0019548Efficacy and Safety of Dulaglutide Monotherapy Compared to Glimepiride in Oral Antihyperglycemic Medication-Naïve Chinese patients with Type 2 Diabetes: A Post Hoc Analysis of AWARD-CHN1.
Li YM, Diabetes therapy : research, treatment and education of diabetes and related disorders
2020Randomized trialPMID 32219675DOIcites ClinicalTrials.gov:NCT01644500; registry reference DERIVED:32219675
R0022828Efficacy and Safety of Dulaglutide by Baseline HbA1c in Chinese Patients with Type 2 Diabetes: A Post Hoc Analysis.
Yu M, Diabetes therapy : research, treatment and education of diabetes and related disorders
2020Other trialPMID 32277401DOIcites ClinicalTrials.gov:NCT01644500; registry reference DERIVED:32277401
R0023259Efficacy and safety of dulaglutide monotherapy compared with glimepiride in Chinese patients with type 2 diabetes: Post-hoc analyses of a randomized, double-blind, phase III study.
Shi LX, Journal of diabetes investigation
2020Randomized trialPMID 31102326DOIcites ClinicalTrials.gov:NCT01644500
R0023562Efficacy and Safety of Once-Weekly Dulaglutide in Elderly Chinese Patients with Type 2 Diabetes: A Post Hoc Analysis of AWARD-CHN Studies.
Kuang J, Diabetes therapy : research, treatment and education of diabetes and related disorders
2020Other trialPMID 32857293DOIcites ClinicalTrials.gov:NCT01644500; registry reference DERIVED:32857293
R0024457Achieving the composite end-point of glycated hemoglobin <7.0% without weight gain or hypoglycemia with once-weekly dulaglutide in Chinese patients with type 2 diabetes: A post-hoc analysis.
Xiao X, Journal of diabetes investigation
2020Randomized trialPMID 31758850DOIcites ClinicalTrials.gov:NCT01644500
R00329762188-PUB: Efficacy and Safety in Chinese T2D Patients Discontinued from OAM to Once-Weekly Dulaglutide Monotherapy
Yanbing Li, Diabetes
2020OtherDOIcites ClinicalTrials.gov:NCT01644500
R0024635A Randomized Study to Compare the Effects of Once-Weekly Dulaglutide Injection and Once-Daily Glimepiride on Glucose Fluctuation of Type 2 Diabetes Mellitus Patients: A 26-Week Follow-Up.
Li H, Journal of diabetes research
2019Randomized trialPMID 31183384DOIcites ClinicalTrials.gov:NCT01644500; registry reference DERIVED:31183384
R00395992313-PUB: Efficacy by Baseline BMI with Once Weekly Dulaglutide in Chinese T2DM Patients
Yongquan Shi, Diabetes
2019Randomized trialDOIcites ClinicalTrials.gov:NCT01644500