Study S001404

The Efficacy and Safety of Once-Weekly, Subcutaneous Dulaglutide Compared to Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Mellitus on Metformin and/or a Sulfonylurea

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT01648582
Acronym: AWARD-CHN2
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 774
Start: 2012-07
Primary completion: 2014-08
Lead sponsor: Eli Lilly and Company
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:Dulaglutide; DRUG:Insulin glargine; DRUG:Metformin; DRUG:Sulfonylureas
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:H9X-CR-GBDK

Registered primary outcomes

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks [Baseline, 26 Weeks]

Linked records (10)

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.

Record	Title	Year	Design	Identifiers	Link basis
R0007330	Effects of GLP-1 Receptor Agonists on Bone Mineral Density in Patients with Type 2 Diabetes Mellitus: A 52-Week Clinical Study. Cai TT, BioMed research international	2021	Randomized trial	PMID 34580638 DOI	cites ClinicalTrials.gov:NCT01648582; registry reference DERIVED:34580638
R0019120	Efficacy and Safety of Once Weekly Dulaglutide in East Asian Patients with Type 2 Diabetes: Subgroup Analysis by Potential Influential Factors. Ma J, Diabetes therapy : research, treatment and education of diabetes and related disorders	2021	Other trial	PMID 33161492 DOI	cites ClinicalTrials.gov:NCT01648582; registry reference DERIVED:33161492
R0023140	Pancreatic Safety of Once-Weekly Dulaglutide in Chinese Patients with Type 2 Diabetes Mellitus: Subgroup Analysis by Potential Influencing Factors. Zhou Y, Diabetes therapy : research, treatment and education of diabetes and related disorders	2021	Randomized trial	PMID 34453682 DOI	cites ClinicalTrials.gov:NCT01648582; registry reference DERIVED:34453682
R0019392	Evaluation 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	2020	Randomized trial	PMID 32621083 DOI	cites ClinicalTrials.gov:NCT01648582; registry reference DERIVED:32621083
R0022828	Efficacy 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	2020	Other trial	PMID 32277401 DOI	cites ClinicalTrials.gov:NCT01648582; registry reference DERIVED:32277401
R0023562	Efficacy 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	2020	Other trial	PMID 32857293 DOI	cites ClinicalTrials.gov:NCT01648582; registry reference DERIVED:32857293
R0024457	Achieving 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	2020	Randomized trial	PMID 31758850 DOI	cites ClinicalTrials.gov:NCT01648582
R0023346	Efficacy and Safety of Dulaglutide Versus Insulin Glargine in Chinese T2DM Patients: A Subgroup Analysis of a Randomized Trial (AWARD-CHN2). Li Y, Diabetes therapy : research, treatment and education of diabetes and related disorders	2019	Randomized trial	PMID 31228090 DOI	cites ClinicalTrials.gov:NCT01648582; registry reference DERIVED:31228090
R0023848	The Effects of Once-Weekly Dulaglutide and Insulin Glargine on Glucose Fluctuation in Poorly Oral-Antidiabetic Controlled Patients with Type 2 Diabetes Mellitus. Wang J, BioMed research international	2019	Randomized trial	PMID 31950036 DOI	cites ClinicalTrials.gov:NCT01648582; registry reference DERIVED:31950036
R0039599	2313-PUB: Efficacy by Baseline BMI with Once Weekly Dulaglutide in Chinese T2DM Patients Yongquan Shi, Diabetes	2019	Randomized trial	DOI	cites ClinicalTrials.gov:NCT01648582