Exenatide-study.

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26218

Enrollment

Registered

2005-09-09

Start date

2004-10-15

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus.

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 glucos

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Glycaemic control and beta-cell function, measured at baseline and after 52 weeks of exenatide or insulin glargine administration.	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactMathijs C.M. Bunck

VU University Medical Center, Diabetes Center Department of Endocrinology, De Boelelaan 1117, room L-049

mcmbunck@vumc.nl+31 (0)20 4442789

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)