Who is sponsoring BoneGlyc?

BoneGlyc is sponsored by Centro de Diabetes Curitiba Ltda.

What condition does BoneGlyc study?

BoneGlyc studies Type 2 Diabetes Mellitus, Menopause, Osteoporosis, Osteopenia.

What drugs are being tested in BoneGlyc?

Interventions: Vildagliptin, Gliclazide MR.

What is the status of BoneGlyc?

BoneGlyc is currently COMPLETED.

Last reviewed 2016-11-02 · How we verify

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

NCT01679899 Phase 4 COMPLETED

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.

Details

Lead sponsor	Centro de Diabetes Curitiba Ltda
Phase	Phase 4
Status	COMPLETED
Enrolment	56
Start date	2012-12
Completion	2015-10

Conditions

Type 2 Diabetes Mellitus
Menopause
Osteoporosis
Osteopenia

Interventions

Vildagliptin
Gliclazide MR

Primary outcomes

Markers of bone remodeling — 6 months
Primary outcome is to compare the effect of vildagliptin with gliclazide MR on markers of bone remodeling. The outcome variables are the blood levels of: 1. Osteocalcin (OC) 2. Bone-specific alkaline phosphatase (BALP) 3. Carboxy-terminal telopeptide of type I collagen (CTX) 4. Amino-terminal telopeptide of type I collagen (NTX)

Countries

Brazil