Study Of AVANDAMET With Or Without Insulin In Type II Diabetes Mellitus Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

October 1, 2003

Last Updated Date

May 15, 2009

Start Date ^ICMJE

October 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Change from baseline in HbA1c [ Time Frame: 24 weeks ]

Original Primary Outcome Measures ^ICMJE

Change from baseline in HbA1c

Change History

Complete list of historical versions of study NCT00069836 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Insulin dose, FPG,glycaemic responders, beta-cell function, hypoglycaemia, treatment satisfaction [ Time Frame: 24 weeks ]

Original Secondary Outcome Measures ^ICMJE

Insulin dose, FPG,glycaemic responders, beta-cell function, hypoglycaemia, treatment satisfaction

Descriptive Information

Brief Title ^ICMJE

Study Of AVANDAMET With Or Without Insulin In Type II Diabetes Mellitus Patients

Official Title ^ICMJE

A 24 Week, Randomised, Double Blind, Parallel Study to Compare the Change in HbA1c With AVANDAMET* (8.0 mg / 2.0 g) Plus Insulin to Placebo Plus Insulin, in Subjects With Type 2 Diabetes Starting Insulin Therapy

Brief Summary

This study was designed to test the safety and efficacy (how well it works) of AVANDAMET in combination with insulin in improving the control of blood sugar when compared with taking insulin on its own. AVANDAMET capsules contain a fixed dose of AVANDIA and metformin. Both AVANDIA and metformin are medicines which are individually licensed for the treatment of type II diabetes mellitus. Because they act in different ways, it is thought that combining them may give an increased benefit of treating diabetes and reducing blood sugar.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Non-Insulin-Dependent Diabetes Mellitus

Intervention ^ICMJE

Drug: Rosiglitazone/metformin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

272

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients must have been diagnosed with type II diabetes mellitus and not have adequate glycaemic controlled while receiving at least 1.5g of metformin.
Patients must have a body mass index of greater than 25 kg/m2 and must not suffer from ankle swelling.

Exclusion Criteria:

Patients cannot have any form of congestive heart failure or severe or unstable angina.
Patients cannot be currently receiving insulin, but be prepared to begin insulin treatment.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria, France, Germany, Italy, Spain

Administrative Information

NCT ID ^ICMJE

NCT00069836

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

712753/009, AVANDAMET Plus Insulin

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD FRCP

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP