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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?

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27919
Enrollment
22
Registered
2006-02-07
Start date
2004-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes. Type 2 diabetes is a heterogeneous disorder involving varying levels of insulin insensitivity and impaired islet beta-cell function.

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 2

Sponsors

Academic Medical Center - Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Established coronary heart disease; 2. Previous use of a thiazolidinedione.

Design outcomes

Primary

MeasureTime frame
The peak insulin concentrations during the hyperglycaemic clamp protocol.

Contacts

Public ContactS.G.H.A. Swinnen

Academic Medical Center, Department of Internal Medicine F4-257, P.O. box 22660

S.G.Swinnen@amc.uva.nl+31 (0)20 5667836

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)