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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Osteoporosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Vildagliptin
Gliclazide
Hypoglycemic Agents
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014