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

ISRCTN	ISRCTN87762302
DOI	https://doi.org/10.1186/ISRCTN87762302
ClinicalTrials.gov (NCT)	NCT00097500
Protocol serial number	N/A
Sponsor	Eli-Lilly (The Netherlands)
Funder	Eli Lilly and Company

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 11/04/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mathijs C.M. Bunck
Scientific

VU University Medical Center
Diabetes Center Department of Endocrinology
De Boelelaan 1117
Room L-049
Amsterdam
1081 HV
Netherlands

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

Study information

Primary study design	Interventional
Study design	Phase III randomized open-label comparator-controlled parallel-group, multicenter
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	Exenatide improves first and second phase insuline secretion compared to insulin glargine.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Exenatide, insulin glargine
Primary outcome measure(s)	Glycaemic control and beta-cell function, measured at baseline and after 52 weeks of exenatide or insulin glargine administration.
Key secondary outcome measure(s)	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.
Completion date	31/12/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	75
Key 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.
Key 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
Date of first enrolment	15/10/2004
Date of final enrolment	31/12/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

VU University Medical Center

Amsterdam
1081 HV
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2009	21/02/2019	Yes	No
Basic results				No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

11/04/2019: Internal review.
21/02/2019: Publication reference added.
21/03/2016: added link to results - basic reporting.