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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00069836

Enrollment

272

Registered

2003-10-03

Start date

2003-10-31

Completion date

2004-11-30

Last updated

2016-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

AVANDAMET insulin type 2 diabetes

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.

Interventions

DRUGRosiglitazone/metformin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change from baseline in HbA1c	24 weeks

Secondary

Measure	Time frame
Insulin dose, FPG,glycaemic responders, beta-cell function, hypoglycaemia, treatment satisfaction	24 weeks

Countries

Austria, France, Germany, Italy, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026