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 number | NCT00097500 |
| Secondary identifying numbers | N/A |
- 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
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 |
|---|---|
| mcmbunck@vumc.nl |
Study information
| Study design | Phase III randomized open-label comparator-controlled parallel-group, multicenter |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | 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 study start date | 15/10/2004 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 3 sites: Netherlands, Sweden and Finland, 25 patients each |
| 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
1081 HV
Netherlands
Sponsor information
Eli-Lilly (The Netherlands)
Not defined
Not defined
Lilly Nederland BV P.O. Box 379
Houten
3990 GD
Netherlands
"ROR" |
https://ror.org/02ve0bg52 |
|---|
Funders
Funder type
Industry
Eli Lilly and Company
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Lilly, Eli Lilly & Company, Eli Lilly & Co., Eli Lilly And Co
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Results article | results | 01/05/2009 | 21/02/2019 | Yes | No |
Editorial Notes
11/04/2019: Internal review.
21/02/2019: Publication reference added.
21/03/2016: added link to results - basic reporting.
