NCT01679899

Effect of Anti-diabetic Drugs on Bone Metabolism and Glycemic Variability

Effect of Anti-diabetic Drugs on Bone Metabolism and Glycemic Variability.A Comparison Between Vildagliptin and Gliclazide MR

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Centro de Diabetes Curitiba Ltda · Academic / Other
• Sex: Female
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Monocentric, Prospective, Randomized, Open-label, Comparative, Phase IV Study, to compare the effects of Vildagliptin and Gliclazide MR on Markers of Bone Remodeling, Bone Mineral Density and Glycemic Variability in Postmenopausal Women with Type 2 Diabetes. A total of 38 women with documented Type 2 Diabetes and menopause will be enrolled. The active treatment will include a 50 mg dose of vildagliptin OD twice a day. As comparator, gliclazide MR will be administered at a dose of 60 to 120 mg OD once a day.

Detailed description

This is a Monocentric, Prospective, Randomized, Open-label, Comparative, Phase IV Study, to compare the effects of Vildagliptin and Gliclazide MR on Markers of Bone Remodeling, Bone Mineral Density and Glycemic Variability in Postmenopausal Women with Type 2 Diabetes. Target population of clinical trial subjects A total of 38 women with documented Type 2 Diabetes and menopause will be enrolled. To be as close to a real life scenario as possible, clinical trial subjects which are treated with glucose-lowering medication (except incretin or sulfonylurea based therapies) and treatment-naive subjects will be included. Investigational Product, posology and method of administration The active treatment will include a 50 mg dose of vildagliptin OD twice a day. Comparator, posology and method of administration As comparator, gliclazide MR will be administered at a dose of 60 to 120 mg OD once a day. Treatment duration The study will have an expected total duration of 18 months, 12 months of active treatment.

Conditions

• Type 2 Diabetes Mellitus
• Menopause
• Osteoporosis
• Osteopenia

Interventions

Type	Name	Description
DRUG	Vildagliptin	Vildagliptin 50mg bid orally for 12 months
DRUG	Gliclazide MR	Gliclazide MR 60 or 120mg orally for 12 months

Timeline

• Start date: 2012-12-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2012-09-06
• Last updated: 2016-11-04

Locations

1 site across 1 country: Brazil