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Exenatide-study.


- candidate number1477
- NTR NumberNTR283
- ISRCTNISRCTN87762302
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR9-sep-2005
- Secondary IDsN/A 
- Public TitleExenatide-study.
- Scientific TitleA Phase 3, Randomised, Open-Label, Comparator-Controlled, Parallel-Group, Multicenter Study to Compare the Effects of Exenatide and Insulin Glargine on Beta-Cell Function and Cardiovascular Risk Markers in Subjects With Type 2 Diabetes Treated With Metformin Who Have Not Achieved Target HbA1c.
- ACRONYMExenatide-study
- hypothesisExenatide improves first and second phase insuline secretion compared to insulin glargine.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II)
- Inclusion criteria1. Patients with type 2 diabetes mellitus (m/f);
2. 30-70 years of age;
3. Body mass index 25-40 kg/m2;
4. Using stable (>2 months) oral anti-diabetic therapy with metformine alone;
5. Subjects must have HbA1c between 6.6% and 9.5%, inclusive.
- Exclusion criteria1. Use of oral anti-diabetic therapy other than metformine.
2. Clinical significant history or presence of hepatic-, renal-, central nervous system-, gastrointestinal-, haematological- and pulmonary disease;
3. Blood pressure >165/95.
4. Electrocardiogram with clinically significant abnormalities as judged by the investigator;
5. The use of prohibited medication as specified in the protocol.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-okt-2004
- planned closingdate31-dec-2006
- Target number of participants75
- InterventionsRandomisation in 2 arms (exenatide vs. insulin glargine). The duration of the intervention is 52 weeks. Exenatide and insulin glargine dose titration will be based upon HbA1c and fasting plasma glucose, respectively.
- Primary outcomeGlycaemic control and beta-cell function, measured at baseline and after 52 weeks of exenatide or insulin glargine administration.
- Secondary outcome1. Postprandial blood glucose, lipids, lipoproteins and markers of inflammation, coagulation, endothelial function;
2. Proportion of subjects with baseline HbA1c >7.0% that achieve HbA1c 7.0%. Proportion of subjects with baseline HbA1c >6.5% that achieve HbA1c 6.5%;
3. Seven-point self-monitored blood glucose profiles.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. Mathijs C.M. Bunck
- CONTACT for SCIENTIFIC QUERIESMD. PhD. FRCP. R.J. Heine
- Sponsor/Initiator Eli-Lilly
- Funding
(Source(s) of Monetary or Material Support)
Eli Lilly Nederland B.V.
- PublicationsN/A
- Brief summaryA Phase 3, randomised, open-label, comparator-controlled, parallel-group, multicenter, study is comparing the effects of exenatide and insulin glargine on beta-cell function in subjects with type 2 diabetes mellitus who have not achieved target HbA1c (7.0%) using metformin therapy.
75 insulin-naive subjects (25 per research center and approximately 37 per treatment group) will be studied.
Subjects will be males or females, 30 to 70 years of age, with a BMI 25 kg/m2 and 40 kg/m2 at screening.
Subjects must have a HbA1c between 6.6% and 9.5%, inclusive.
- Main changes (audit trail)
- RECORD8-sep-2005 - 14-sep-2009


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