A Type 2 Diabetes Study of the Longer-Term Glycemic Effect of AVANDAMET vs. Metformin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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.
    

Intervention name(s): Avandamet 6 mg/1500 mg (ttd); Avandamet 4 mg/1000 mg (ttd); Avandamet 2 mg/500 mg (ttd); Avandamet 8 mg/ 2000 mg (ttd); Metformin 500 mg (ttd); Metformin 1000 mg (ttd); Metformin 1500 mg (ttd); Metformin 2000 mg (ttd)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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; 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.; 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.; 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.; 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.; 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.; 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.; 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.
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fasting Plasma Glucose; Dual energy X ray absorptiometry (DXA); Drug-naive; Type 2 diabetes mellitus; Bone Mineral Density; Hyperglycemia; HbA1c