Study Of AVANDAMET With Or Without Insulin In Type II Diabetes Mellitus Patients

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00069836
First received: October 1, 2003
Last updated: February 11, 2013
Last verified: November 2011

October 1, 2003
February 11, 2013
October 2003
November 2004   (final data collection date for primary outcome measure)
Change from baseline in HbA1c [ Time Frame: 24 weeks ]
Not Provided
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 ]
Not Provided
Not Provided
Not Provided
 
Study Of AVANDAMET With Or Without Insulin In Type II Diabetes Mellitus Patients
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

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Diabetes Mellitus, Type 2
  • Non-Insulin-Dependent Diabetes Mellitus
Drug: Rosiglitazone/metformin
Other Name: Rosiglitazone/metformin
Not Provided
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.
 
Completed
272
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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Austria,   France,   Spain,   Italy
 
NCT00069836
712753/009
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2011

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