Study S001198

The Impact of LY2189265 Versus Insulin Glargine in Combination With Insulin Lispro for the Treatment to Target of Type 2 Diabetes Mellitus (AWARD-4: Assessment of Weekly AdministRation of LY2189265 in Diabetes - 4)

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT01191268
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 884
Start: 2010-11
Primary completion: 2012-02
Lead sponsor: Eli Lilly and Company
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Insulin Glargine; DRUG:LY2189265; DRUG:Insulin Lispro
Results posted: TRUE
Secondary identifiers: OTHER:H9X-MC-GBDD

Registered primary outcomes

Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c) [Baseline, 26 weeks]

Linked records (5)

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
R0024573	Dulaglutide 1.5 mg as an add-on option for patients uncontrolled on insulin: Subgroup analysis by age, duration of diabetes and baseline glycated haemoglobin concentration. Pantalone KM, Diabetes, obesity & metabolism	2018	Randomized trial	PMID 29430801 DOI	cites ClinicalTrials.gov:NCT01191268; registry reference DERIVED:29430801
R0020285	Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Yu M, Diabetes, obesity & metabolism	2016	Other trial	PMID 26691396 DOI	cites ClinicalTrials.gov:NCT01191268; registry reference DERIVED:26691396
R0025090	Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged ≥65 and <65 years. Boustani MA, Diabetes, obesity & metabolism	2016	Other trial	PMID 27161178 DOI	cites ClinicalTrials.gov:NCT01191268; registry reference DERIVED:27161178
R0018020	Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a randomised, open-label, phase 3, non-inferiority study. Blonde L, Lancet (London, England)	2015	Randomized trial	PMID 26009229 DOI	cites ClinicalTrials.gov:NCT01191268; registry reference DERIVED:26009229
R0049983	Dulaglutide Reduces HbA1c More Than Glargine When Used in Combination with Prandial Insulin Maria Vinall, MD Conference Express	2014	Other trial	DOI	cites ClinicalTrials.gov:NCT01191268