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

This study is currently recruiting participants.
Verified July 2013 by Centro de Diabetes Curitiba Ltda
Sponsor:
Information provided by (Responsible Party):
Centro de Diabetes Curitiba Ltda
ClinicalTrials.gov Identifier:
NCT01679899
First received: September 2, 2012
Last updated: July 15, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Menopause
Osteoporosis
Osteopenia
Drug: Vildagliptin
Drug: Gliclazide MR
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Anti-diabetic Drugs on Bone Metabolism and Glycemic Variability.A Comparison Between Vildagliptin and Gliclazide MR

Resource links provided by NLM:


Further study details as provided by Centro de Diabetes Curitiba Ltda:

Primary Outcome Measures:
  • Markers of bone remodeling [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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)


Secondary Outcome Measures:
  • Bone mineral density of lumbar spine and femur by X-ray absorptiometry [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Glycemic variability [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

  • Calcitonin [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Dosage of serum calcitonin


Other Outcome Measures:
  • Levels of aminotransferases [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Dosage of alanine aminotransferase (ALT, SGOT) and aspartate aminotransferase (AST, SGPT)


Estimated Enrollment: 38
Study Start Date: December 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vildagliptin
Vildagliptin 50 mg bid for 12 months
Drug: Vildagliptin
Vildagliptin 50mg bid orally for 12 months
Other Name: 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 Name: Diamicron MR

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679899

Contacts
Contact: Andre GD Vianna, MD +55(41)30231252 vianna.a@uol.com.br
Contact: Edgard Niclewicz, MD +55(41)30231252 edgardniclewicz@terra.com.br

Locations
Brazil
Centro de Diabetes Curitiba Recruiting
Curitiba, Parana, Brazil, 80810040
Contact: Marinez Jucovski, Coordinator    +55(41)92368794    pesquisaclinica_mari@yahoo.com.br   
Principal Investigator: Andre GD Vianna, MD         
Sub-Investigator: Claudio S Lacerda, MD         
Sub-Investigator: Luciana M Pechmann, MD         
Sub-Investigator: Andressa M Leitao, MD         
Sub-Investigator: Edgard D Niclewicz, MD         
Sponsors and Collaborators
Centro de Diabetes Curitiba Ltda
Investigators
Study Chair: Andre GD Vianna, MD Centro de Diabetes Curitiba
  More Information

No publications provided

Responsible Party: Centro de Diabetes Curitiba Ltda
ClinicalTrials.gov Identifier: NCT01679899     History of Changes
Other Study ID Numbers: BoneGlyc
Study First Received: September 2, 2012
Last Updated: July 15, 2013
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Centro de Diabetes Curitiba Ltda:
diabetes
type 2 diabetes mellitus
osteopenia
osteoporosis
glycemic variability
bone markers
osteocalcin
NTX
CTX
BALP

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Bone Diseases, Metabolic
Osteoporosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Bone Diseases
Musculoskeletal Diseases
Vildagliptin
Gliclazide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014