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Does treatment with rosiglitazone result in improved pancreatic beta-cell function as compared to glimepiride in metformin treated diabetes type 2 patients?


- candidate number1969
- NTR NumberNTR605
- ISRCTNISRCTN52245496
- Date ISRCTN created8-mrt-2006
- date ISRCTN requested7-mrt-2006
- Date Registered NTR7-feb-2006
- Secondary IDsN/A 
- Public TitleDoes treatment with rosiglitazone result in improved pancreatic beta-cell function as compared to glimepiride in metformin treated diabetes type 2 patients?
- Scientific TitleDoes treatment with rosiglitazone result in improved pancreatic beta-cell function as compared to glimepiride in metformin treated diabetes type 2 patients?
- ACRONYMN/A
- hypothesisBy 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 sulfonylureumderivative, while both groups continue metformin treatment.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II)
- Inclusion criteria1. Informed consent form signed;
2. Type 2 diabetes patients, accoring to WHO criteria;
3. Age 18-70 years;
4. Use of metformin, at least 500 mg a day;
5. HbA1c > 7.0% inclusive when on metformin alone, or > 6.5 % when on combination therapy of metformin and a sulfonylureumderivative.
Use of a sulfonylureumderivative is allowed, with a wash-out period of four weeks before the first assessments.
- Exclusion criteria1. Established coronary heart disease;
2. Previous use of a thiazolidinedione.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2004
- planned closingdate1-apr-2007
- Target number of participants22
- InterventionsPatients will be randomized 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 min. hyperglycaemic (aiming at 15 mmmol/l) clamp with administration of glucagon-like peptide-1 (GLP-1) starting at 120 min. and an arginine bolus at 180 min. 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 outcomeThe peak insulin concentrations during the hyperglycaemic clamp protocol.
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIES S.G.H.A. Swinnen
- CONTACT for SCIENTIFIC QUERIESDr. J.H. Vries, de
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
GlaxoSmithKline
- PublicationsN/A
- Brief summaryStudy title:
Does treatment with rosiglitazon result in improved pancreatic -cell function as compared to glimepiride in metformin treated diabetes type 2 patients?

Introduction:
Thiazolidinediones, a new class of insulin sensitizing agents, have been shown to induce a shift of fat out of the visceral compartment among which the pancreas into the subcutaneous compartment. This could also result in a restoration or preservation of endogenous insulin secretion capacity, loss of which is one of the fundamental defects in Type 2 diabetes. A recent study could not confirm this hypothesis, but various shortcomings in the design of this previous study can be noted, most notably a treatment period that is likely to have been too short, and the fact that patients were not using metformin, the standard treatment for type 2 diabetes.

Aim of the study:
To investigate the effect of rosiglitazon treatment on -cell function in type 2 diabetes patients as compared to a sulfonylureumderivative, while both groups continue metformin treatment.

Design:
Twenty-two patients will be randomized to metformin with glimepiride 4 mg a day or metformin with rosiglitazon 8 mg a day.

Patients:
Eligible patients are those with Type 2 diabetes using metformin. Exclusion criteria are established coronary heart disease and previous use of a thiazolidinedione.

Measurements:
Patients will undergo a 200 min hyperglycaemic (aiming at 10 mmol/l) clamp with administration of glucagon-like peptide-1 (GLP-1) starting at 120 min (bolus injection of 4.5 pmol/kg followed by a continuous infusion of 1.5 pmol/kg/min until the end of the clamp) and an arginine (5 g) bolus at 180 min to elicit a further -cell response. Twenty-six weeks later, the assessments will be repeated, again on metformin, other study medication taken until the morning before this assessment.

Outcome measures:
Primary outcome measure will be the peak insulin concentrations during the hyperglycaemic clamp protocol.

Burden for the participants:
The risk for participants is judged to be minor. Participation mainly requires an investment of time and undergoing insertion of the sensors and blood sampling.

8-Aug-2007: trial has stopped because of stop cause problems with inclusion of patients.
- Main changes (audit trail)
- RECORD7-feb-2006 - 16-nov-2009


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