No registrations found.
ID
Source
Brief title
Health condition
Type 2 Diabetes Mellitus.
Sponsors and support
Intervention
Outcome measures
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.
Background 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.
Study objective
Exenatide improves first and second phase insuline secretion compared to insulin glargine.
Study design
N/A
Intervention
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.
De Boelelaan 1117, room L-049
Mathijs C.M. Bunck
De Boelelaan 1117
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4442789
mcmbunck@vumc.nl
De Boelelaan 1117, room L-049
Mathijs C.M. Bunck
De Boelelaan 1117
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4442789
mcmbunck@vumc.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL245 |
| NTR-old | NTR283 |
| Other | : N/A |
| ISRCTN | ISRCTN87762302 |