Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/03/2006
Date assigned
08/03/2006
Last edited
04/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr S G H A Swinnen

ORCID ID

Contact details

Academic Medical Centre
Department of Internal Medicine F4-257
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 7836
S.G.Swinnen@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR605

Study information

Scientific title

Acronym

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.

Ethics approval

Received from local medical ethics committee

Study design

Randomised active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Rosiglitazone, glimepiride, metformin, glucagon-like peptide-1, arginine

Primary outcome measures

The peak insulin concentrations during the hyperglycaemic clamp protocol.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/09/2004

Overall trial end date

01/04/2007

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

22

Participant exclusion criteria

1. Established coronary heart disease
2. Previous use of a thiazolidinedione

Recruitment start date

01/09/2004

Recruitment end date

01/04/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (The Netherlands)

Sponsor details

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl

Funders

Funder type

Industry

Funder name

GlaxoSmithKline (The Netherlands)

Alternative name(s)

GlaxoSmithKline Plc., GSK

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes