|- candidate number||1969|
|- NTR Number||NTR605|
|- Date ISRCTN created||8-mrt-2006|
|- date ISRCTN requested||7-mrt-2006|
|- Date Registered NTR||7-feb-2006|
|- Secondary IDs||N/A |
|- 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||Does treatment with rosiglitazone result in improved pancreatic beta-cell function as compared to glimepiride in metformin treated diabetes type 2 patients?|
|- 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 sulfonylureumderivative, while both groups continue metformin treatment.|
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 2 (DM type II)|
|- Inclusion criteria||1. 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 criteria||1. Established coronary heart disease;|
2. Previous use of a thiazolidinedione.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2004|
|- planned closingdate||1-apr-2007|
|- Target number of participants||22|
|- Interventions||Patients 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 outcome||The peak insulin concentrations during the hyperglycaemic clamp protocol.|
|- Secondary outcome||N/A|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| S.G.H.A. Swinnen|
|- CONTACT for SCIENTIFIC QUERIES||Dr. J.H. Vries, de|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|- Brief summary||Study title:|
Does treatment with rosiglitazon result in improved pancreatic ß-cell function as compared to glimepiride in metformin treated diabetes type 2 patients?
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.
Twenty-two patients will be randomized to metformin with glimepiride 4 mg a day or metformin with rosiglitazon 8 mg a day.
Eligible patients are those with Type 2 diabetes using metformin. Exclusion criteria are established coronary heart disease and previous use of a thiazolidinedione.
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.
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)|
|- RECORD||7-feb-2006 - 16-nov-2009|