CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 688 enrolled
Drug / intervention
Avandamet 6 mg/1500 mg (ttd) +7 moredrug
Likely dose
Avandamet 6 mg/1500 mg (ttd)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00386100
NCT00386100Phase 4Completed
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A Randomized, Parallel Group, Double-blind, Multi-center Study Comparing the Efficacy and Safety of AVANDAMET and Metformin After 80 Weeks of Treatment.

GlaxoSmithKline·interventional·Posted Oct 11, 2006·Updated Nov 23, 2016

In Brief

A Phase 4 clinical trial evaluating Avandamet 6 mg/1500 mg (ttd), Avandamet 4 mg/1000 mg (ttd), and 6 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 688 participants across 116 sites in 9 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesArgentina, Brazil, Canada, Mexico, Pakistan, Philippines, South Korea, Taiwan, United States
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 11, 2006
Enrollment StartOct 1, 2006
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 19.7 years ago

Interventions

Avandamet 6 mg/1500 mg (ttd)drug

One 2 mg/ 500 mg capsule will be taken in the AM with the morning meal Two 2 mg/ 500 mg capsules will be taken in the PM with the evening meal

Avandamet 4 mg/1000 mg (ttd)drug

One 2 mg/500 mg capsule will be taken in the AM with the morning meal. One 2 mg/500 mg capsule will be taken in the PM with the evening meal.

Avandamet 2 mg/500 mg (ttd)drug

one placebo capsule will be taken in the AM with the morning meal one 2 mg/ 500 mg capsule will be taken in the PM with the evening meal.

Avandamet 8 mg/ 2000 mg (ttd)drug

Two 2 mg/ 500 mg capsules will be taken in the AM with the morning meal. Two 2 mg/ 500 mg capsules will be taken in the PM with the evening meal.

Metformin 500 mg (ttd)drug

One placebo capsule will be taken in the AM with the morning meal. One 500 mg capsule will be taken in the PM with the evening meal.

Metformin 1000 mg (ttd)drug

One 500 mg capsule will be taken in the AM with the morning meal. One 500 mg capsule will be taken in the PM with the evening meal.

Metformin 1500 mg (ttd)drug

One 500 mg capsule will be taken in the AM with the morning meal. Two 500 mg capsules will be taken in the PM with the evening meal.

Metformin 2000 mg (ttd)drug

Two 500 mg capsule will be taken in the AM with the morning meal. Two 500 mg capsule will be taken in the PM with the evening meal.