Study Of AVANDAMET® With Or Without Insulin In Type II Diabetes Mellitus Patients. AVANDAMET® is a Registered Trademark of the GSK Group of Companies.

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2	Drug: Rosiglitazone/metformin	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	272 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	October 2003
Actual Primary Completion Date :	November 2004
Actual Study Completion Date :	November 2004

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Arm 1	Drug: Rosiglitazone/metformin

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

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  Show 93 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

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Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. 

Study Data/Documents: Informed Consent Form 

Identifier: 712753/009
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: 712753/009
For additional information about this study please refer to the GSK Clinical Study Register

Annotated Case Report Form 

Identifier: 712753/009
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: 712753/009
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: 712753/009
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: 712753/009
For additional information about this study please refer to the GSK Clinical Study Register

Dataset Specification 

Identifier: 712753/009
For additional information about this study please refer to the GSK Clinical Study Register

Publications of Results:

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:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00069836 History of Changes
Other Study ID Numbers:	712753/009
First Posted:	October 3, 2003
Last Update Posted:	September 1, 2016
Last Verified:	August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:

AVANDAMET insulin type 2 diabetes

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases	Insulin, Globin Zinc; Rosiglitazone; Insulin; Hypoglycemic Agents; Physiological Effects of Drugs