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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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00069836
Recruitment Status : Completed
First Posted : October 3, 2003
Last Update Posted : September 1, 2016
Information provided by (Responsible Party):

October 1, 2003
October 3, 2003
September 1, 2016
October 2003
November 2004   (Final data collection date for primary outcome measure)
Change from baseline in HbA1c [ Time Frame: 24 weeks ]
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Complete list of historical versions of study NCT00069836 on ClinicalTrials.gov Archive Site
Insulin dose, FPG,glycaemic responders, beta-cell function, hypoglycaemia, treatment satisfaction [ Time Frame: 24 weeks ]
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Study Of AVANDAMET® With Or Without Insulin In Type II Diabetes Mellitus Patients. AVANDAMET® is a Registered Trademark of the GSK Group of Companies.
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
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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: Rosiglitazone/metformin
Experimental: Arm 1
Intervention: Drug: Rosiglitazone/metformin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
November 2004
November 2004   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Austria,   France,   Germany,   Italy,   Spain
United Kingdom
Not Provided
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.
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
August 2016

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