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

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
Diabetes Mellitus, Type 2 Non-Insulin-Dependent Diabetes Mellitus	Drug: Rosiglitazone/metformin	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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 Medicines

Drug Information available for: Metformin Rosiglitazone Rosiglitazone Maleate Rosiglitazone-metformin combination

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
Study Completion Date:	November 2004
Primary Completion Date:	November 2004 (Final data collection date for primary outcome measure)

Intervention Details:

Other Name: Rosiglitazone/metformin

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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	GlaxoSmithKline

More Information

Publications:

Home PD, Bailey CJ, Donaldson J, Chen H, Stewart MW. A double-blind randomized study comparing the effects of continuing or not continuing rosiglitazone + metformin therapy when starting insulin therapy in people with Type 2 diabetes. Diabet Med. 2007 Jun;24(6):618-25. Epub 2007 Apr 2. Erratum in: Diabet Med. 2010 May;27(5):611.


Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00069836 History of Changes
Other Study ID Numbers:	712753/009
Study First Received:	October 1, 2003
Last Updated:	February 11, 2013
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Spain: Spanish Agency of Medicines United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:


AVANDAMET insulin type 2 diabetes

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases	Rosiglitazone Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 03, 2015