A Study Of Rosiglitazone Plus Insulin To Treat Type 2 Diabetes Mellitus Patients

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

PHASE3

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Brief Summary

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This study is designed to demonstrate that addition of rosiglitazone (4mg) to insulin in Type 2 diabetes mellitus subjects who have not achieved glycemic goals on insulin injections alone is efficacious in terms of improving glycemic control.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Rosiglitazone

4mg

Group Type EXPERIMENTAL

Rosiglitazone 4 mg

Intervention Type DRUG

Rosiglitazone placebo

4mg

Group Type PLACEBO_COMPARATOR

Rosiglitazone 4 mg

Intervention Type DRUG

Interventions

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Rosiglitazone 4 mg

Intervention Type DRUG

Other Intervention Names

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Insulin

Eligibility Criteria

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Inclusion Criteria

* Patients with type 2 Diabetes mellitus on a minimum dose of 30 units/day insulin monotherapy continuously for at least 8 weeks
* If Patients are taking another oral antidiabetic agent may stop their oral agent and adjust their insulin dose properly over 8 weeks prior to screening if they are asked by doctor who considers him/her suitable for study in all other respects, and the HbA1c level\>7.5%.

Exclusion:

* Fasting plasma glucose \>13 mmol/L at screening
* Ongoing edema or history of peripheral edema requiring pharmacological treatment within 12 months
* Drug abuse
* Women pregnant or lactating
* Use any rosiglitazone like drug in 3 months
* Use more than one oral antidiabetic agent in 2 months
* Uncontrolled hypertension
* Chronic heart failure
* Anemia

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No