Study Of AVANDAMET® With Or Without Insulin In Type II Diabetes Mellitus Patients. AVANDAMET® is a Registered Trademark of the GSK Group of Companies.
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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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 | Drug: Rosiglitazone/metformin | Phase 3 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm 1 | Drug: Rosiglitazone/metformin |
- Change from baseline in HbA1c [ Time Frame: 24 weeks ]
- Insulin dose, FPG,glycaemic responders, beta-cell function, hypoglycaemia, treatment satisfaction [ Time Frame: 24 weeks ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00069836

Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Additional Information:
Study Data/Documents: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register
Publications of Results:
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00069836 History of Changes |
Other Study ID Numbers: |
712753/009 |
First Posted: | October 3, 2003 Key Record Dates |
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 |