LivingGLP1
Study S002279

A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of Exenatide Long-Acting Release on Glucose Control (HbA1c) and Safety in Subjects With Type 2 Diabetes Mellitus Managed With Diet Modification and Exercise and/or Oral Antidiabetic Medications

Included trial: extracted dataClinicalTrials.gov record

Registration

Registration
NCT00308139
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
NONE
Status
COMPLETED
Enrollment
303
Start
2006-04
Primary completion
2008-07
Lead sponsor
AstraZeneca
Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG:exenatide, long acting release; DRUG:exenatide
Results posted
TRUE
Secondary identifiers
OTHER:MB001-010

Registered primary outcomes

  • Change in HbA1c From Baseline to Week 30 [Day -3, Week 30]
  • Sub-study Relative Bioavailability of Exenatide When Administered Using the Exenatide Once Weekly Dual Chambered Pen and the Exenatide Once Weekly Single Dose Tray (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose) [Week 22]

Linked records (13)

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
R0024642Efficacy and tolerability of exenatide once weekly over 7 years in patients with type 2 diabetes: An open-label extension of the DURATION-1 study.
Philis-Tsimikas A, Journal of diabetes and its complications
2019Randomized trialPMID 30600137DOIcites ClinicalTrials.gov:NCT00308139; registry reference DERIVED:30600137
R0025866Efficacy and Tolerability of Exenatide Once Weekly Over 6 Years in Patients with Type 2 Diabetes: An Uncontrolled Open-Label Extension of the DURATION-1 Study.
Henry RR, Diabetes technology & therapeutics
2016Randomized trialPMID 27525540DOIcites ClinicalTrials.gov:NCT00308139; registry reference DERIVED:27525540
R0041109Running Title: Exenatide once weekly, 52-wk safety & efficacy
Weight Loss
2016Other trialcites ClinicalTrials.gov:NCT00308139
R0026018Five-year efficacy and safety data of exenatide once weekly: long-term results from the DURATION-1 randomized clinical trial.
Wysham CH, Mayo Clinic proceedings
2015Randomized trialPMID 25744115DOIcites ClinicalTrials.gov:NCT00308139; registry reference DERIVED:25744115
R0051378Once Weekly Exenatide is Safe and Effective for Long-term T2DM Treatment
Lynne Lederman, MD Conference Express
2014Other trialDOIcites ClinicalTrials.gov:NCT00308139
R0018479Exenatide once weekly: sustained improvement in glycemic control and cardiometabolic measures through 3 years.
Macconell L, Diabetes, metabolic syndrome and obesity : targets and therapy
2013Randomized trialPMID 23358123DOIcites ClinicalTrials.gov:NCT00308139; registry reference DERIVED:23358123
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:NCT00308139; registry reference DERIVED:23748506
R0017687Treatment with exenatide once weekly or twice daily for 30 weeks is associated with changes in several cardiovascular risk markers.
Chiquette E, Vascular health and risk management
2012Other trialPMID 23166441DOIcites ClinicalTrials.gov:NCT00308139; registry reference DERIVED:23166441
R0026474Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment.
Fineman MS, Diabetes, obesity & metabolism
2012OtherPMID 22236356DOIcites ClinicalTrials.gov:NCT00308139; registry reference DERIVED:22236356
R0051816Exenatide Once Weekly Sustained Improvement in Glycemic Control with Weight Loss through 4 Years
Robert E. Buckley, MD Conference Express
2012Other trialDOIcites ClinicalTrials.gov:NCT00308139
R0019676Exenatide once weekly treatment maintained improvements in glycemic control and weight loss over 2 years.
Taylor K, BMC endocrine disorders
2011Other trialPMID 21529363DOIcites ClinicalTrials.gov:NCT00308139; registry reference DERIVED:21529363
R0019054DURATION-1: exenatide once weekly produces sustained glycemic control and weight loss over 52 weeks.
Buse JB, Diabetes care
2010Randomized trialPMID 20215461DOIcites ClinicalTrials.gov:NCT00308139; registry reference DERIVED:20215461
R0025313Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study.
Drucker DJ, Lancet (London, England)
2008Randomized trialPMID 18782641DOIcites ClinicalTrials.gov:NCT00308139; registry reference DERIVED:18782641