Metabolic Effects of Pioglitazone in Type II Diabetic Patients Previously Treated With Insulin (PIOswitch)

IKFE Institute for Clinical Research and Development

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus; Insulin Resistance

Treatments: Drug: pioglitazone and glimepiride

Study type: Interventional

Funder types: Other

Identifiers

NCT00576784

TAK-PIO-004.2

ATS-K-013

Details and patient eligibility

About

The goal of the study is to demonstrate whether a switch from insulin therapy to an oral therapy with pioglitazone/glimepiride will lead to a deterioration of glycemic control (increase in HbA1c by more than 0.5 %) within a 6 month observation period.

Full description

To demonstrate that reconverting type 2 diabetic patients from insulin treatment to oral treatment using pioglitazone in combination with or without glimepiride is possible without deterioration of blood glucose control.

Primary aim is to maintain glycaemic control (HbA1c) defined as an increase in HbA1c of not more than 0.5 % after 6 months of treatment (visit 7) compared to baseline HbA1c value (screening visit V1).

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• type 2 diabetes mellitus
• insulin therapy > 1 year
• residual ß-cell function (C-peptide increase in iv glucagon test)
• written informed consent

Exclusion criteria

• type 1 diabetes
• oral therapy
• life-threatening disease
• heart failure (NYHA I-IV)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

A

Active Comparator group

Description:

pioglitazone/glimepiride

Treatment:

Drug: pioglitazone and glimepiride