|- candidate number||1477|
|- NTR Number||NTR283|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||9-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||Exenatide-study.|
|- Scientific Title||A 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.|
|- hypothesis||Exenatide improves first and second phase insuline secretion compared to insulin glargine.|
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 2 (DM type II)|
|- Inclusion criteria||1. 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 criteria||1. 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 received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-okt-2004|
|- planned closingdate||31-dec-2006|
|- Target number of participants||75|
|- Interventions||Randomisation 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 outcome||Glycaemic control and beta-cell function, measured at baseline and after 52 weeks of exenatide or insulin glargine administration.|
|- Secondary outcome||1. 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.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MD. Mathijs C.M. Bunck|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. FRCP. R.J. Heine|
|- Sponsor/Initiator ||Eli-Lilly|
(Source(s) of Monetary or Material Support)
|Eli Lilly Nederland B.V.|
|- Brief summary||A 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 ³25 kg/m2 and £40 kg/m2 at screening.
Subjects must have a HbA1c between 6.6% and 9.5%, inclusive.
|- Main changes (audit trail)|
|- RECORD||8-sep-2005 - 14-sep-2009|