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

NCT01679899 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2016-11-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Vildagliptin

Vildagliptin 50mg bid orally for 12 months

DRUG

Gliclazide MR

Gliclazide MR 60 or 120mg orally for 12 months

Sponsors & Collaborators

  • Centro de Diabetes Curitiba Ltda

    lead OTHER

Principal Investigators

  • Andre GD Vianna, MD · Centro de Diabetes Curitiba

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01679899 on ClinicalTrials.gov