Does treatment with rosiglitazone result in improved pancreatic beta-cell function as compared to glimepiride in metformin treated diabetes type 2 patients?
| ISRCTN | ISRCTN52245496 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52245496 |
| Secondary identifying numbers | NTR605 |
- Submission date
- 08/03/2006
- Registration date
- 08/03/2006
- Last edited
- 04/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr S G H A Swinnen
Scientific
Scientific
Academic Medical Centre
Department of Internal Medicine F4-257
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 566 7836 |
|---|---|
| S.G.Swinnen@amc.uva.nl |
Study information
| Study design | Randomised active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | By inducing a shift of fat out of the visceral compartment - among which the pancreas - into the subcutaneous compartment, rosiglitazone results in improved pancreatic beta-cell function in type 2 diabetes patients, as compared to a sulfonylurea derivative, while both groups continue metformin treatment. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Diabetes mellitus type II (DM type II) |
| Intervention | Patients will be randomised to 26 weeks of treatment with metformin with glimepiride 4 mg a day or metformin with rosiglitazone 8 mg a day. Before the start of the treatment patients will undergo a 200 minute hyperglycaemic (aiming at 15 mmol/l) clamp with administration of glucagon-like peptide-1 (GLP-1) starting at 120 minutes and an arginine bolus at 180 minutes to elicit a further beta-cell response. Twenty-six weeks later, the assessments will be repeated, again on metformin, other study medication taken until the morning before this assessment. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Rosiglitazone, glimepiride, metformin, glucagon-like peptide-1, arginine |
| Primary outcome measure | The peak insulin concentrations during the hyperglycaemic clamp protocol. |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/09/2004 |
| Completion date | 01/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 22 |
| Key inclusion criteria | 1. Informed consent form signed 2. Type 2 diabetes patients, according to World Health Organization (WHO) criteria 3. Age 18 - 70 years 4. Use of metformin, at least 500 mg a day 5. HbA1c greater than 7.0% inclusive when on metformin alone, or greater than 6.5% when on combination therapy of metformin and a sulfonylurea derivative. Use of a sulfonylurea derivative is allowed, with a wash-out period of four weeks before the first assessments. |
| Key exclusion criteria | 1. Established coronary heart disease 2. Previous use of a thiazolidinedione |
| Date of first enrolment | 01/09/2004 |
| Date of final enrolment | 01/04/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Website | http://www.amc.uva.nl |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Industry
GlaxoSmithKline (The Netherlands)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- GlaxoSmithKline plc., GSK plc., GSK
- Location
- United Kingdom
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 |
