Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Randomized, Parallel Group, Double-blind, Multi-center Study Comparing the Efficacy and Safety of AVANDAMET and Metformin After 80 Weeks of Treatment.
This study will evaluate the longer-term glycemic effect of two medicines approved for initial treatment of type 2 diabetes. The study consists of a 2 week screening period (2 study visits), followed by an 80 week double-blind treatment period (11 study visits). Also, a sub-study was included to look at changes in bone mineral density (BMD) at the lumbar spine.
This was a phase IV, randomized, double-blind, global, multi-centre study. The study
consisted of a 2 week screening period followed by an 80 week double-blind treatment period.
Subjects who met all eligibility requirements were randomized in a 1:1 ratio, stratified by
country, gender (male and female) and pre-screening HbA1c (≤9% or>9) either to MET or AVM.
When the substudy was added, a new randomization was created for the participating centers.
Those subjects in the bone sub-study were stratified by country, gender (male, premenopausal
female, and postmenopausal female), pre-screening HbA1c (i.e., ≤9%; >9%), and either to MET
or AVM.
At randomization, Visit 3 (Week 0), subjects were initiated at Dose Level 1. Treatment with
AVM was initiated at a dose of 4 mg/500 mg and titrated up to a maximum total daily dose of
AVM 8 mg/2000 mg. Treatment with MET therapy was initiated at a dose of 500 mg and titrated
up to a maximum daily dose of 2000mg.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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