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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00641056
Registration number
NCT00641056
Ethics application status
Date submitted
17/03/2008
Date registered
21/03/2008
Date last updated
15/06/2015
Titles & IDs
Public title
Efficacy of Exenatide Once Weekly and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea (DURATION - 3)
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Scientific title
Efficacy of Once-Weekly Exenatide Long-Acting Release and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea
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Secondary ID [1]
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H8O-MC-GWBR (DURATION - 3)
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Exenatide Once Weekly
Treatment: Drugs - Insulin Glargine
Experimental: 1 -
Active comparator: 2 -
Treatment: Drugs: Exenatide Once Weekly
subcutaneous injection, 2.0mcg, once weekly
Treatment: Drugs: Insulin Glargine
subcutaneous injection, variable dose, QD
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in HbA1c From Baseline to Week 26
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Assessment method [1]
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Change in HbA1c from baseline to Week 26
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Timepoint [1]
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Baseline, Week 26
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Secondary outcome [1]
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Percentage of Patients Achieving HbA1c <=7.0% at Week 26
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Assessment method [1]
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Percentage of patients achieving HbA1c \<=7.0% at Week 26 (for patients with HbA1c \>7% at baseline)
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Timepoint [1]
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Baseline, Week 26
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Secondary outcome [2]
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Percentage of Patients Achieving HbA1c <=6.5% at Week 26
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Assessment method [2]
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Percentage of patients achieving HbA1c \<=6.5% at Week 26 (for patients with HbA1c \>6.5% at baseline)
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Timepoint [2]
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Baseline, Week 26
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Secondary outcome [3]
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Change in Fasting Serum Glucose (FSG) From Baseline to Week 26
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Assessment method [3]
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Change in FSG (mmol/L) from Baseline to Week 26
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Timepoint [3]
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Baseline, Week 26
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Secondary outcome [4]
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Change in Body Weight (BW) From Baseline to Week 26
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Assessment method [4]
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Change in BW (kg) from Baseline to Week 26
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Timepoint [4]
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Baseline, Week 26
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Secondary outcome [5]
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Change in Total Cholesterol From Baseline to Week 26
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Assessment method [5]
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Change in Total Cholesterol (mmol/L) from Baseline to Week 26
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Timepoint [5]
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Baseline, Week 26
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Secondary outcome [6]
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Change in High-density Lipoprotein Cholesterol (HDL) From Baseline to Week 26
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Assessment method [6]
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Change in HDL (mmol/L) from Baseline to Week 26
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Timepoint [6]
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Baseline, Week 26
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Secondary outcome [7]
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Ratio of Triglycerides at Week 26 to Baseline
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Assessment method [7]
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Ratio of Triglycerides (measured in mmol/L) at Week 26 to Baseline. Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.
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Timepoint [7]
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Baseline, Week 26
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Secondary outcome [8]
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Change in Blood Pressure From Baseline to Week 26
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Assessment method [8]
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Change in Systolic Blood Pressure (mmHg) and Diastolic Blood Pressure (mmHg) from Baseline to Week 26
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Timepoint [8]
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Baseline, Week 26
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Secondary outcome [9]
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Assessment on Event Rate of Treatment-emergent Hypoglycemic Episodes
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Assessment method [9]
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Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose or documented hypoglycemia (blood glucose \<3.0 mmol/L \[54 mg/dL\]) and required the assistance of another person. Minor hypoglycemia: any time a patient felt that he or she was experiencing a sign or symptom of hypoglycemia that was self-treated or resolved on its own and had a blood glucose level \<3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia.
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Timepoint [9]
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Baseline to Week 26
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Eligibility
Key inclusion criteria
* Has type 2 diabetes and at least 18 years of age at screening.
* Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening.
* Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.
* Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).
* Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening OR
* Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening and have been treated with SU for at least 3 months and have been taking a stable dose of at least an optimally effective dose of brand of SU for 8 weeks prior to screening.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Have had a clinically significant history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty; or is expected to require coronary artery bypass surgery or angioplasty during the course of the study.
* Have clinical signs or symptoms of liver disease, acute or chronic hepatitis.
* Have a history of renal transplantation or are currently receiving renal dialysis.
* Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
* Have had greater than three episodes of major hypoglycemia within 6 months prior to screening.
* Have any contraindication for the oral antidiabetic agent which they use.
* Have a known allergy or hypersensitivity to insulin glargine, exenatide once weekly, or excipients contained in these agents.
* Are known to have active proliferative retinopathy.
* Have been treated with drugs that promote weight loss (e.g., Xenical® [orlistat], Meridia® [sibutramine], Acomplia® [rimonabant], Acutrim® [phenylpropanolamine], or similar over-the-counter medications) within 3 months of screening.
* Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening:
* Insulin
* Thiazolidinediones (e.g., Actos® [pioglitazone] or Avandia® [rosiglitazone])
* Alpha-glucosidase inhibitors (e.g., Glyset® [miglitol] or Precose® [acarbose])
* Meglitinides (e.g., Prandin® [repaglinide] or Starlix® [nateglinide]).
* Byetta® (exenatide BID formulation)
* Dipeptidyl peptidase (DPP)-4 inhibitors (e.g., Januvia™ [sitagliptin], Galvus® [vildagliptin])
* Symlin® (pramlintide acetate).
* Have had an organ transplant.
* Have donated blood within 30 days of screening.
* Have previously completed or withdrawn from this study or any other study investigating exenatide once weekly.
* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
* Are currently enrolled in any other clinical study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2009
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Sample size
Target
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Accrual to date
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Final
467
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Research Site - Box Hill
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Research Site - Geelong
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- Wollongong
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- Herston
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- Adelaide
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- Keswick
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- Box Hill
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Recruitment postcode(s) [6]
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- Geelong
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Recruitment outside Australia
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California
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Oklahoma
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Edegem
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Melnik
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Praha
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Aalborg
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Fulda
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Speyer
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Moscow
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Russian Federation
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Rostov-on-Don
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St. Petersburg
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Alicante
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Malaga
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Teruel
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Taipei
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Taiwan
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Taoyuan
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Eli Lilly and Company
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Ethics approval
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Summary
Brief summary
The purpose of this study is to compare the effects of 2.0 mg exenatide once weekly and insulin glargine, titrated to glucose targets using the algorithm described by Yki- Järvinen et al.(2007), with respect to glycemic improvements, body weight, fasting lipids, safety, and tolerability.
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Trial website
https://clinicaltrials.gov/study/NCT00641056
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Trial related presentations / publications
Diamant M, Van Gaal L, Stranks S, Guerci B, MacConell L, Haber H, Scism-Bacon J, Trautmann M. Safety and efficacy of once-weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes over 84 weeks. Diabetes Care. 2012 Apr;35(4):683-9. doi: 10.2337/dc11-1233. Epub 2012 Feb 22. Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18. Erratum In: Diabetes Ther. 2020 Dec;11(12):3011-3013. doi: 10.1007/s13300-020-00842-w. Diamant M, Van Gaal L, Guerci B, Stranks S, Han J, Malloy J, Boardman MK, Trautmann ME. Exenatide once weekly versus insulin glargine for type 2 diabetes (DURATION-3): 3-year results of an open-label randomised trial. Lancet Diabetes Endocrinol. 2014 Jun;2(6):464-73. doi: 10.1016/S2213-8587(14)70029-4. Epub 2014 Apr 4. Erratum In: Lancet Diabetes Endocrinol. 2014 Jun;2(6):e13. Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660. Meloni AR, DeYoung MB, Han J, Best JH, Grimm M. Treatment of patients with type 2 diabetes with exenatide once weekly versus oral glucose-lowering medications or insulin glargine: achievement of glycemic and cardiovascular goals. Cardiovasc Diabetol. 2013 Mar 23;12:48. doi: 10.1186/1475-2840-12-48. Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10. Diamant M, Van Gaal L, Stranks S, Northrup J, Cao D, Taylor K, Trautmann M. Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open-label randomised trial. Lancet. 2010 Jun 26;375(9733):2234-43. doi: 10.1016/S0140-6736(10)60406-0.
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Public notes
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Contacts
Principal investigator
Name
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Chief Medical Officer, MD
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Address
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Eli Lilly and Company
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Diamant M, Van Gaal L, Stranks S, Guerci B, MacCon...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT00641056
Download to PDF