LivingGLP1
Study S000305

A Randomized, Parallel-Arm, Double-Blind Study of Efficacy and Safety of Dulaglutide When Added to SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus

Registration

Registration
NCT02597049
Acronym
AWARD-10
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
DOUBLE
Status
COMPLETED
Enrollment
424
Start
2015-11
Primary completion
2017-02
Lead sponsor
Eli Lilly and Company
Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG:Dulaglutide; DRUG:Placebo; DRUG:SGLT2 inhibitor; DRUG:Metformin
Results posted
TRUE
Individual participant data sharing
YES
Secondary identifiers
OTHER:H9X-MC-GBGE; EUDRACT_NUMBER:2015-002095-24; NIH:2015

Registered primary outcomes

  • Change From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand) [Baseline, Week 24]
  • Change From Baseline in the HbA1c at 24 Weeks (Efficacy Estimand) [Baseline, Week 24]

Linked records (3)

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
R0008191Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes.
Ferdinand KC, Cardiovascular diabetology
2023Systematic reviewPMID 36894938DOIcites ClinicalTrials.gov:NCT02597049; registry reference DERIVED:36894938
R0020348Dulaglutide as add-on therapy to SGLT2 inhibitors in patients with inadequately controlled type 2 diabetes (AWARD-10): a 24-week, randomised, double-blind, placebo-controlled trial.
Ludvik B, The lancet. Diabetes & endocrinology
2018Randomized trialPMID 29483060DOIcites ClinicalTrials.gov:NCT02597049; registry reference DERIVED:29483060
R0021793Exenatide once weekly plus dapagliflozin once daily versus exenatide or dapagliflozin alone in patients with type 2 diabetes inadequately controlled with metformin monotherapy (DURATION-8): a 28 week, multicentre, double-blind, phase 3, randomised controlled trial.
Frías JP, The lancet. Diabetes & endocrinology
2016Randomized trialPMID 27651331DOIcites ClinicalTrials.gov:NCT02597049