Effect of Pioglitazone Versus Metformin on Bone Health in Postmenopausal Women With Type 2 Diabetes

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

The study tests whether pioglitazone (PIO)as compared to metformin (MET)affects bone health including bone mineral density, bone turnover markers, and osteocyte biomarker in patients with type 2 diabetes (T2DM).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King Abdulaziz University
• Treatments: Metformin; Pioglitazone

Criteria

Inclusion Criteria:

• BMD T-score greater than -2.5 at the total hip, femoral neck, and lumbar spine;

• No prior antidiabetic therapy;

• Drug-naïve with glycosylated hemoglobin A1c (HbA1c) ≥ 7.0 to ≤ 10.0%. 53.2 mmol/mol to 88.2 mmol/mol);

• Body-mass index of 40 Kg/m2 and less;

• Stable body weight for at least 4 months.

Exclusion Criteria:

• Type 1 diabetes mellitus (presence of GAD auto antibodies);

• History of diabetes or uncontrolled hypertension;

• Treatment with antidiabetic agents including TZDs;

• Chronic diseases known to affect bone;

• Previous treatment with estrogens and other medications known to affect bone ;

• Creatinine clearance less than 60 ml/min