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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2

Treatments: Drug: Rosiglitazone 4 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00349427

AVD102209

Details and patient eligibility

About

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.

Enrollment: 256 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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256 participants in 2 patient groups, including a placebo group

Rosiglitazone

Experimental group

Description:

4mg

Treatment:

Drug: Rosiglitazone 4 mg

Rosiglitazone placebo

Placebo Comparator group

Description:

4mg

Treatment:

Drug: Rosiglitazone 4 mg