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

NCT ID: NCT00576784

Last Updated: 2007-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-04-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Type 2 Diabetes Mellitus Insulin Resistance

Keywords

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type 2 diabetes insulin treatment ß-cell function

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

pioglitazone/glimepiride

Group Type ACTIVE_COMPARATOR

pioglitazone and glimepiride

Intervention Type DRUG

switch from any insulin treatment to 30 mg pioglitazone and 3 mg glimepiride.

Interventions

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pioglitazone and glimepiride

switch from any insulin treatment to 30 mg pioglitazone and 3 mg glimepiride.

Intervention Type DRUG

Other Intervention Names

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Actos - pioglitazone Amaryl - glimepiride

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IKFE Institute for Clinical Research and Development

OTHER

Sponsor Role lead

Responsible Party

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IKFE

Locations

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IKFE

Mainz, , Germany

Site Status

Countries

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Germany

Other Identifiers

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TAK-PIO-004.2

Identifier Type: -

Identifier Source: secondary_id

ATS-K-013

Identifier Type: -

Identifier Source: org_study_id