LivingGLP1
Study S000446

A Randomized, Double-Blind Trial Comparing the Effect of Dulaglutide 1.5 mg With Placebo on Glycemic Control in Patients With Type 2 Diabetes on Basal Insulin Glargine

Registration

Registration
NCT02152371
Acronym
AWARD-9
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
DOUBLE
Status
COMPLETED
Enrollment
300
Start
2014-05
Primary completion
2015-10
Lead sponsor
Eli Lilly and Company
Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG:Dulaglutide; DRUG:Placebo; DRUG:Insulin Glargine; DRUG:Metformin
Results posted
TRUE
Individual participant data sharing
YES
Secondary identifiers
OTHER:H9X-MC-GBDI; EUDRACT_NUMBER:2012-004229-25

Registered primary outcomes

  • Change From Baseline to 28 Weeks in Hemoglobin A1c (HbA1c) [Baseline, 28 Weeks]

Linked records (2)

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
R0024573Dulaglutide 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
2018Randomized trialPMID 29430801DOIcites ClinicalTrials.gov:NCT02152371; registry reference DERIVED:29430801
R0024710Patient-reported Outcomes in Patients with Type 2 Diabetes Treated with Dulaglutide Added to Titrated Insulin Glargine (AWARD-9).
Yu M, Clinical therapeutics
2017Randomized trialPMID 29110972DOIcites ClinicalTrials.gov:NCT02152371; registry reference DERIVED:29110972