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A Phase III, randomized, 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

A Phase III, randomized, 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
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN87762302
Enrollment
75
Registered
2005-12-20
Start date
2004-10-15
Completion date
Unknown
Last updated
2019-05-05

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

Conditions

Diabetes Mellitus type II (DM type II) Nutritional, Metabolic, Endocrine Diabetes

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

Sponsors

Eli-Lilly (The Netherlands)
Lead Sponsor

Eligibility

Sex/Gender
All

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 metformin 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 metformin 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

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

Secondary

MeasureTime 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.—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026