Study Of AVANDAMET® With Or Without Insulin In Type II Diabetes Mellitus Patients. AVANDAMET® is a Registered Trademark of the GSK Group of Companies.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
A 24 Week, Randomised, Double Blind, Parallel Study to Compare the Change in HbA1c With AVANDAMET® (8.0mg / 2.0g) Plus Insulin to Placebo Plus Insulin, in Subjects With Type 2 Diabetes Starting Insulin Therapy
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Actual Primary Completion Date :
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.