|
ISRCTN
|
ISRCTN52245496
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Does treatment with rosiglitazone result in improved pancreatic beta-cell function as compared to glimepiride in metformin treated diabetes type 2 patients?
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
NTR605
|
|
Study hypothesis
|
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.
|
|
Lay summary
|
|
|
Ethics approval
|
Received from local medical ethics committee
|
|
Study design
|
Randomised active controlled, parallel group trial
|
|
Countries of recruitment
|
Netherlands
|
|
Disease/condition/study domain
|
Diabetes mellitus type II (DM type II)
|
|
Participants - 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.
|
|
Participants - exclusion criteria
|
1. Established coronary heart disease
2. Previous use of a thiazolidinedione
|
|
Anticipated start date
|
01/09/2004
|
|
Anticipated end date
|
01/04/2007
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
22
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
The peak insulin concentrations during the hyperglycaemic clamp protocol.
|
|
Secondary outcome measure(s)
|
No secondary outcome measures
|
|
Sources of funding
|
GlaxoSmithKline (The Netherlands)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
S G H A
Swinnen
|
|
Address
|
Academic Medical Centre
Department of Internal Medicine F4-257
P.O. Box 22660
|
|
City/town
|
Amsterdam
|
|
Zip/Postcode
|
1100 DD
|
|
Country
|
Netherlands
|
|
Tel
|
+31 (0)20 566 7836
|
|
Fax
|
+31 (0)20 691 4904
|
|
Email
|
S.G.Swinnen@amc.uva.nl
|
|
Sponsor
|
Academic Medical Centre (AMC) (The Netherlands)
|
|
Address
|
P.O. Box 22660
|
|
City/town
|
Amsterdam
|
|
Zip/Postcode
|
1100 DD
|
|
Country
|
Netherlands
|
|
Sponsor website:
|
http://www.amc.uva.nl
|
|
Date applied
|
08/03/2006
|
|
Last edited
|
04/11/2008
|
|
Date ISRCTN assigned
|
08/03/2006
|
