Rosiglitazone In Subjects With Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00329225
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This 24-week study will compare the effects of adding the drug rosiglitazone (2mg and 4mg) or placebo to insulin in patients with Type 2 diabetes mellitus (non-insulin-dependent) who have not achieved their blood glucose goal using insulin alone. This study requires a total of seven visits during 28 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Primary Completion: 2004-04
• Study Completion: 2004-04
• Study First Submitted: 2006-05-22
• Study First Submitted QC: 2006-05-22
• Study First Posted: 2006-05-24
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-13
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 630

Inclusion Criteria

• Have Type II diabetes mellitus (non-insulin-dependent).
• Females must be post-menopausal (> 12 months without a menstrual period), surgically sterile, or must be using oral contraceptive, Norplant, Depo-provera, an IUD, or a diaphragm with spermicide or condoms. Females of childbearing potential must use acceptable contraceptive measures for at least one month prior to screening and for 30 days after completing the study.
• Must have been on insulin therapy alone continuously for at least 8 weeks prior to screening (minimum dose of 30 units per day). Patients taking insulin in combination with a single oral antidiabetic agent may have their oral agent discontinued and their insulin dose optimized over an 8 week period prior to screening if they are considered good study candidates in all other respects.
• HbA1c > 7.5% at Pre-screen or at Screen for subjects who discontinue their antidiabetic agent at pre-screening.
• Provide signed Informed Consent.

Exclusion Criteria

• Females who are lactating, pregnant, or planning to become pregnant.
• Use of any drug called a thiazolidinedione within 6 months prior to screening, or more than one oral antidiabetic agent (including combinations of agents such as Glucovance) in combination with insulin in the 3 months prior to screening.
• Use of any investigational drug for blood glucose control within 3 months of screening regardless of the treatment regimen, or use of any other investigational agent within 30 days preceding study entry.
• Use of niacin (not including doses found in multivitamins) or oral corticosteroids within 3 months of screening.
• Patients with ongoing swelling due to fluid accumulation or history of such requiring treatment with a drug in the 12 months prior to screening.
• Patients with a documented history of significant hypersensitivity (e.g., difficulty swallowing, difficulty breathing, tachycardia or skin reaction) to the drugs called thiazolidinediones or similar drugs, or with prior fluid related intolerability to thiazolidinediones.
• Presence of clinically significant kidney or liver disease.
• Anemia.
• Presence of unstable or severe angina or coronary insufficiency.
• Patients with ongoing CHF (chronic heart failure) or history of CHF.
• Recent history or suspicion of current drug abuse or alcohol abuse.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c at each visit	28 Weeks

Secondary Outcome Measures

Name	Time	Method
FPG at each visit C-peptide at each visit lipids at each visit BNP at each visit CRP at each visit PAI-1 at each visit MMP-9 at each visit	28 Weeks

Trial Locations

Locations (1)

GSK Investigational Site