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

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ClinicalTrials.gov Identifier: NCT01679899
Recruitment Status : Completed
First Posted : September 6, 2012
Last Update Posted : November 4, 2016
Sponsor:
Information provided by (Responsible Party):
Centro de Diabetes Curitiba Ltda

Study Description
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Brief 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.


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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2012
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. Calcitonin [ Time Frame: 12 months ]
    Dosage of serum calcitonin


Other Outcome Measures:
  1. Levels of aminotransferases [ Time Frame: 6 months ]
    Dosage of alanine aminotransferase (ALT, SGOT) and aspartate aminotransferase (AST, SGPT)


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679899


Locations
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Brazil
Centro de Diabetes Curitiba
Curitiba, Parana, Brazil, 80810040
Sponsors and Collaborators
Centro de Diabetes Curitiba Ltda
Investigators
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Study Chair: Andre GD Vianna, MD Centro de Diabetes Curitiba
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Centro de Diabetes Curitiba Ltda
ClinicalTrials.gov Identifier: NCT01679899    
Other Study ID Numbers: BoneGlyc
First Posted: September 6, 2012    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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:
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Osteoporosis
Bone Diseases, Metabolic
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Bone Diseases
Musculoskeletal Diseases
 Vildagliptin
Gliclazide
Hypoglycemic Agents
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action