Efficacy and Safety In Poorly Controlled Type 2 Diabetics

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A 24-week Randomized, Double-Blind, Parallel-Group, Multicenter Study to Demonstrate the Efficacy and Safety of Two Different Rosiglitazone Dosing Regimens, 4mg OD and 8mg OD, in Poorly-Controlled Drug Naive Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00044460
• Other study ID #: 49653/326
• Status: Completed
• Phase: Phase 4
• First received: August 29, 2002
• Last updated: October 5, 2017
• Start date: May 2002
• Est. completion date: April 10, 2003

Study information

• Verified date: October 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to gain safety and efficacy information in patients with type 2 diabetes, who have not previously taken any oral antidiabetic medications, and who have an HbA1c value of greater than or equal to 10%, despite diet and exercise.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: April 10, 2003
• Est. primary completion date: April 10, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria:

• Type 2 diabetes

• Drug-naive.

• Laboratory test result for HbA1c of greater than or equal to 10%.

• Written informed consent.

Exclusion criteria:

• Prior use of antidiabetic medications within 3 months of screening.

• Fluid retention (edema).

• Significant liver disease.

• Low red blood cells (anemia).

• Severe or unstable angina (chest pain).

• Congestive heart failure.

• Severe high blood pressure.

• Alcohol or drug abuse.

• Other inclusion or exclusion criteria to be determined by the physician and study sponsor.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• rosiglitazone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

References & Publications (2)

Abstract: The Effects of Rosiglitazone in Poorly-Controlled, Drug-Naive Patients with Type 2 Diabetes Mellitus, KATHLEEN L. WYNE, ALEXANDER R. COBITZ, BRIAN R. WATERHOUSE, LEANNE J. STROW. Dallas, TX; King of Prussia, PA; Orlando, FL; USA. 64th Annual Sci

Wyne KL, Cobitz AR, Waterhouse BR, Strow LJ. The effects of rosiglitazone in poorly-controlled drug-naive patients with type 2 diabetes mellitus. Diabetes 2004;53(Suppl 2):A152. Poster 639 presented at ADA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c from baseline to Week 24.
Secondary	Change in FPG (fasting plasma glucose) from baseline to Week 24; characterize the effects of rosiglitazone on the albumin-creatinine ratio at Week 24.

External Links

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