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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00069836

Purpose

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.

Condition	Intervention	Phase
Non-Insulin-Dependent Diabetes Mellitus	Drug: Rosiglitazone/metformin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Rosiglitazone Rosiglitazone Maleate Avandamet Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	272
Study Start Date:	October 2003

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069836

Show 91 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD FRCP

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	712753/009, AVANDAMET Plus Insulin
Study First Received:	October 1, 2003
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00069836 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; United States: Food and Drug Administration; Spain: Spanish Agency of Medicines

Keywords provided by GlaxoSmithKline:

AVANDAMET insulin type 2 diabetes

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Rosiglitazone
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Glucose Metabolism Disorders
Rosiglitazone
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on July 02, 2009