Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00069836
First received: October 1, 2003
Last updated: August 31, 2016
Last verified: August 2016
  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
Drug: Rosiglitazone/metformin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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 ]

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)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Rosiglitazone/metformin

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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 93 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 712753/009
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 712753/009
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 712753/009
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 712753/009
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 712753/009
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 712753/009
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 712753/009
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00069836     History of Changes
Other Study ID Numbers: 712753/009 
Study First Received: October 1, 2003
Last Updated: August 31, 2016
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
Individual Participant Data  
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

ClinicalTrials.gov processed this record on December 09, 2016