LivingGLP1
Study S001966

Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes

Registration

Registration
NCT00676338
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
DOUBLE
Status
COMPLETED
Enrollment
820
Start
2008-11
Primary completion
2010-07
Lead sponsor
AstraZeneca
Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG:exenatide once weekly; DRUG:metformin; DRUG:sitagliptin; DRUG:pioglitazone
Results posted
TRUE

Registered primary outcomes

  • Change in HbA1c From Baseline to Week 26 [Baseline, Week 26]
  • Percentage of Patients Achieving HbA1c <=7% at Week 26 [Baseline, Week 26]

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.
RecordTitleYearDesignIdentifiersLink basis
R0013562Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease.
Guja C, Diabetes therapy : research, treatment and education of diabetes and related disorders
2020Other trialPMID 32306296DOIcites ClinicalTrials.gov:NCT00676338; registry reference DERIVED:32306296
R0019490Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials.
Grimm M, Postgraduate medicine
2013Randomized trialPMID 23748506DOIcites ClinicalTrials.gov:NCT00676338; registry reference DERIVED:23748506
R0024240Treatment of patients with type 2 diabetes with exenatide once weekly versus oral glucose-lowering medications or insulin glargine: achievement of glycemic and cardiovascular goals.
Meloni AR, Cardiovascular diabetology
2013Randomized trialPMID 23522121DOIcites ClinicalTrials.gov:NCT00676338; registry reference DERIVED:23522121
R0025752Efficacy and tolerability of exenatide once weekly versus sitagliptin in patients with type 2 diabetes mellitus: a retrospective analysis of pooled clinical trial data.
Malloy J, Postgraduate medicine
2013Randomized trialPMID 23748507DOIcites ClinicalTrials.gov:NCT00676338; registry reference DERIVED:23748507
R0027761Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): a 26-week double-blind study.
Russell-Jones D, Diabetes care
2012Randomized trialPMID 22210563DOIcites ClinicalTrials.gov:NCT00676338; registry reference DERIVED:22210563