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

November 2, 2016 updated by: Centro de Diabetes Curitiba Ltda

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Parana
      • Curitiba, Parana, Brazil, 80810040
        • Centro de Diabetes Curitiba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Informed consent form obtained before any study-related activity. Study-related activities are any procedure that would not be performed during the normal treatment of the patient.

  • All study subjects must be women diagnosed with type 2 diabetes based on current guidelines of Sociedade Brasileira de Diabetes (SBD - Brazilian Society of Diabetes) and/or American Society of Diabetes (ADA) and they should have all the following criteria:

    • Age ≥ 40 years old.
    • HbA1c ≥ 6.5% at randomization.
  • Menopause defined as:
  • Absence of menstruation for at least 12 months in patients with an intact uterus, or
  • FSH level greater than 30 mIU/mL in a hysterectomized patient and/or,
  • FSH level greater than 30 mIU/mL in a patient with surgical menopause.

Exclusion Criteria:

  • Acute vascular event (cardiac, cerebral or peripheral) for at least 2 months of randomization.
  • Patient on chronic dialysis and/or renal transplantation and/or serum creatinine > 1.5 mg/dL.
  • Patients with HIV, severe autoimmune disease or chronic treatment with oral steroids (> 30 consecutive days).
  • Current or previous treatment (within 6 months) with incretin (DPP-IV inhibitor or GLP-1 analog) within 6 months prior to randomization.
  • Current or previous treatment with pioglitazone or rosiglitazone within 12 months prior to randomization.
  • Sustained arterial hypertension > 180/100 mm Hg.
  • Body mass index (BMI) > 50 kg/m².
  • HbA1c ≥ 9,5% at randomization.
  • Transaminases (AST (SGOT) and ALT (SGPT)) > 2.5 x upper limit of normal.
  • Chronic liver disease or alcoholic liver disease.
  • LDL-cholesterol > 250 mg/dL (> 6.48 mmol/L).
  • Triglycerides > 1000 mg/dL (> 11.3 mmol/L).
  • HDL-cholesterol < 25 mg/dL (< 0.64 mmol/L).
  • Levels of 25-OH-vitamin D < 20ng/mL at randomization
  • Abnormal levels of PTH, cortisol, IGF-1 or GH at randomization
  • Prescription of any investigational medication within one year before the screening visit (visit 1), unless there is a direct benefit to the study subject, at the discretion of the investigator.
  • History of previous fracture
  • Pregnant or breastfeeding patients.
  • Previous participation on this study.
  • Individuals at risk for poor adherence to the protocol or medication.
  • Any condition that makes the patient unable to complete the study within 12 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Vildagliptin
Vildagliptin 50 mg bid for 12 months
Drug: Vildagliptin
Vildagliptin 50mg bid orally for 12 months
Other Names:
  • Galvus
ACTIVE_COMPARATOR: Gliclazide MR
Gliclazide MR 60 or 120mg once a day for 12 months
Drug: Gliclazide MR
Gliclazide MR 60 or 120mg orally for 12 months
Other Names:
  • Diamicron MR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Markers of bone remodeling
Time Frame: 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)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone mineral density of lumbar spine and femur by X-ray absorptiometry
Time Frame: 12 months
To compare the effect of vildagliptin with gliclazide MR on bone mineral density of lumbar spine and femur by X-ray absorptiometry after 12-month treatment.
12 months
Glycemic variability
Time Frame: 6 months
To compare the effect of vildagliptin with gliclazide MR on glycemic variability measured by MAGE method (mean amplitude of glycemic excursion) using a continuous glucose monitoring system
6 months
Calcitonin
Time Frame: 12 months
Dosage of serum calcitonin
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of aminotransferases
Time Frame: 6 months
Dosage of alanine aminotransferase (ALT, SGOT) and aspartate aminotransferase (AST, SGPT)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro de Diabetes Curitiba Ltda

Investigators

  • Study Chair: Andre GD Vianna, MD, Centro de Diabetes Curitiba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

October 1, 2015

Study Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

September 2, 2012

First Submitted That Met QC Criteria

September 5, 2012

First Posted (ESTIMATE)

September 6, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 4, 2016

Last Update Submitted That Met QC Criteria

November 2, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BoneGlyc

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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