Condition category
Nutritional, Metabolic, Endocrine
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
21/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Sponsor information

Organisation

Eli-Lilly (The Netherlands)

Sponsor details

Lilly Nederland BV P.O. Box 379
Houten
3990 GD
Netherlands

Sponsor type

Not defined

Website

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

Results - basic reporting

See https://clinicaltrials.gov/ct2/show/results/NCT00097500

Publication summary

Publication citations

Additional files

Editorial Notes

21/03/2016: added link to results - basic reporting.