Contact information
Type
Scientific
Primary contact
Dr Mathijs C.M. Bunck
ORCID ID
Contact details
VU University Medical Center
Diabetes Center Department of Endocrinology
De Boelelaan 1117
Room L-049
Amsterdam
1081 HV
Netherlands
+31 (0)20 4442789
mcmbunck@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00097500
Protocol/serial number
N/A
Study information
Scientific title
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
Acronym
Study hypothesis
Exenatide improves first and second phase insuline secretion compared to insulin glargine.
Ethics approval
Not provided at time of registration
Study design
Phase III randomized open-label comparator-controlled parallel-group, multicenter
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Diabetes Mellitus type II (DM type II)
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.
Intervention type
Drug
Phase
Phase III
Drug names
Exenatide, insulin glargine
Primary outcome measure
Glycaemic control and beta-cell function, measured at baseline and after 52 weeks of exenatide or insulin glargine administration.
Secondary outcome measures
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.
Overall trial start date
15/10/2004
Overall trial end date
31/12/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
3 sites: Netherlands, Sweden and Finland, 25 patients each
Participant 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
Recruitment start date
15/10/2004
Recruitment end date
31/12/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
VU University Medical Center
Amsterdam
1081 HV
Netherlands
Funders
Funder type
Industry
Funder name
Eli Lilly and Company
Alternative name(s)
Lilly
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
See https://clinicaltrials.gov/ct2/show/results/NCT00097500
Publication list
2009 results in: https://www.ncbi.nlm.nih.gov/pubmed/19196887