Exenatide improves first and second phase insuline secretion compared to insulin glargine.
ID
Bron
Verkorte titel
Aandoening
Type 2 Diabetes Mellitus.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Glycaemic control and beta-cell function, measured at baseline and after 52 weeks of exenatide or insulin glargine administration.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Exenatide improves first and second phase insuline secretion compared to insulin glargine.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL245 |
| NTR-old | NTR283 |
| Ander register | : N/A |
| ISRCTN | ISRCTN87762302 |