<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01679899</url>
  </required_header>
  <id_info>
    <org_study_id>BoneGlyc</org_study_id>
    <nct_id>NCT01679899</nct_id>
  </id_info>
  <brief_title>Effect of Anti-diabetic Drugs on Bone Metabolism and Glycemic Variability</brief_title>
  <acronym>BoneGlyc</acronym>
  <official_title>Effect of Anti-diabetic Drugs on Bone Metabolism and Glycemic Variability.A Comparison Between Vildagliptin and Gliclazide MR</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centro de Diabetes Curitiba Ltda</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centro de Diabetes Curitiba Ltda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Monocentric, Prospective, Randomized, Open-label, Comparative, Phase IV Study, to&#xD;
      compare the effects of Vildagliptin and Gliclazide MR on Markers of Bone Remodeling, Bone&#xD;
      Mineral Density and Glycemic Variability in Postmenopausal Women with Type 2 Diabetes.&#xD;
&#xD;
      A total of 38 women with documented Type 2 Diabetes and menopause will be enrolled. The&#xD;
      active treatment will include a 50 mg dose of vildagliptin OD twice a day. As comparator,&#xD;
      gliclazide MR will be administered at a dose of 60 to 120 mg OD once a day.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Monocentric, Prospective, Randomized, Open-label, Comparative, Phase IV Study, to&#xD;
      compare the effects of Vildagliptin and Gliclazide MR on Markers of Bone Remodeling, Bone&#xD;
      Mineral Density and Glycemic Variability in Postmenopausal Women with Type 2 Diabetes.&#xD;
&#xD;
      Target population of clinical trial subjects A total of 38 women with documented Type 2&#xD;
      Diabetes and menopause will be enrolled. To be as close to a real life scenario as possible,&#xD;
      clinical trial subjects which are treated with glucose-lowering medication (except incretin&#xD;
      or sulfonylurea based therapies) and treatment-naive subjects will be included.&#xD;
&#xD;
      Investigational Product, posology and method of administration The active treatment will&#xD;
      include a 50 mg dose of vildagliptin OD twice a day.&#xD;
&#xD;
      Comparator, posology and method of administration As comparator, gliclazide MR will be&#xD;
      administered at a dose of 60 to 120 mg OD once a day.&#xD;
&#xD;
      Treatment duration The study will have an expected total duration of 18 months, 12 months of&#xD;
      active treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Markers of bone remodeling</measure>
    <time_frame>6 months</time_frame>
    <description>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:&#xD;
Osteocalcin (OC)&#xD;
Bone-specific alkaline phosphatase (BALP)&#xD;
Carboxy-terminal telopeptide of type I collagen (CTX)&#xD;
Amino-terminal telopeptide of type I collagen (NTX)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bone mineral density of lumbar spine and femur by X-ray absorptiometry</measure>
    <time_frame>12 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic variability</measure>
    <time_frame>6 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calcitonin</measure>
    <time_frame>12 months</time_frame>
    <description>Dosage of serum calcitonin</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Levels of aminotransferases</measure>
    <time_frame>6 months</time_frame>
    <description>Dosage of alanine aminotransferase (ALT, SGOT) and aspartate aminotransferase (AST, SGPT)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <condition>Menopause</condition>
  <condition>Osteoporosis</condition>
  <condition>Osteopenia</condition>
  <arm_group>
    <arm_group_label>Vildagliptin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vildagliptin 50 mg bid for 12 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gliclazide MR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Gliclazide MR 60 or 120mg once a day for 12 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vildagliptin</intervention_name>
    <description>Vildagliptin 50mg bid orally for 12 months</description>
    <arm_group_label>Vildagliptin</arm_group_label>
    <other_name>Galvus</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gliclazide MR</intervention_name>
    <description>Gliclazide MR 60 or 120mg orally for 12 months</description>
    <arm_group_label>Gliclazide MR</arm_group_label>
    <other_name>Diamicron MR</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent form obtained before any study-related activity. Study-related&#xD;
             activities are any procedure that would not be performed during the normal treatment&#xD;
             of the patient.&#xD;
&#xD;
          -  All study subjects must be women diagnosed with type 2 diabetes based on current&#xD;
             guidelines of Sociedade Brasileira de Diabetes (SBD - Brazilian Society of Diabetes)&#xD;
             and/or American Society of Diabetes (ADA) and they should have all the following&#xD;
             criteria:&#xD;
&#xD;
               -  Age ≥ 40 years old.&#xD;
&#xD;
               -  HbA1c ≥ 6.5% at randomization.&#xD;
&#xD;
          -  Menopause defined as:&#xD;
&#xD;
          -  Absence of menstruation for at least 12 months in patients with an intact uterus, or&#xD;
&#xD;
          -  FSH level greater than 30 mIU/mL in a hysterectomized patient and/or,&#xD;
&#xD;
          -  FSH level greater than 30 mIU/mL in a patient with surgical menopause.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute vascular event (cardiac, cerebral or peripheral) for at least 2 months of&#xD;
             randomization.&#xD;
&#xD;
          -  Patient on chronic dialysis and/or renal transplantation and/or serum creatinine &gt; 1.5&#xD;
             mg/dL.&#xD;
&#xD;
          -  Patients with HIV, severe autoimmune disease or chronic treatment with oral steroids&#xD;
             (&gt; 30 consecutive days).&#xD;
&#xD;
          -  Current or previous treatment (within 6 months) with incretin (DPP-IV inhibitor or&#xD;
             GLP-1 analog) within 6 months prior to randomization.&#xD;
&#xD;
          -  Current or previous treatment with pioglitazone or rosiglitazone within 12 months&#xD;
             prior to randomization.&#xD;
&#xD;
          -  Sustained arterial hypertension &gt; 180/100 mm Hg.&#xD;
&#xD;
          -  Body mass index (BMI) &gt; 50 kg/m².&#xD;
&#xD;
          -  HbA1c ≥ 9,5% at randomization.&#xD;
&#xD;
          -  Transaminases (AST (SGOT) and ALT (SGPT)) &gt; 2.5 x upper limit of normal.&#xD;
&#xD;
          -  Chronic liver disease or alcoholic liver disease.&#xD;
&#xD;
          -  LDL-cholesterol &gt; 250 mg/dL (&gt; 6.48 mmol/L).&#xD;
&#xD;
          -  Triglycerides &gt; 1000 mg/dL (&gt; 11.3 mmol/L).&#xD;
&#xD;
          -  HDL-cholesterol &lt; 25 mg/dL (&lt; 0.64 mmol/L).&#xD;
&#xD;
          -  Levels of 25-OH-vitamin D &lt; 20ng/mL at randomization&#xD;
&#xD;
          -  Abnormal levels of PTH, cortisol, IGF-1 or GH at randomization&#xD;
&#xD;
          -  Prescription of any investigational medication within one year before the screening&#xD;
             visit (visit 1), unless there is a direct benefit to the study subject, at the&#xD;
             discretion of the investigator.&#xD;
&#xD;
          -  History of previous fracture&#xD;
&#xD;
          -  Pregnant or breastfeeding patients.&#xD;
&#xD;
          -  Previous participation on this study.&#xD;
&#xD;
          -  Individuals at risk for poor adherence to the protocol or medication.&#xD;
&#xD;
          -  Any condition that makes the patient unable to complete the study within 12 months.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andre GD Vianna, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Centro de Diabetes Curitiba</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro de Diabetes Curitiba</name>
      <address>
        <city>Curitiba</city>
        <state>Parana</state>
        <zip>80810040</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>September 2, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>November 2, 2016</last_update_submitted>
  <last_update_submitted_qc>November 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diabetes</keyword>
  <keyword>type 2 diabetes mellitus</keyword>
  <keyword>osteopenia</keyword>
  <keyword>osteoporosis</keyword>
  <keyword>glycemic variability</keyword>
  <keyword>bone markers</keyword>
  <keyword>osteocalcin</keyword>
  <keyword>NTX</keyword>
  <keyword>CTX</keyword>
  <keyword>BALP</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Bone Diseases, Metabolic</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vildagliptin</mesh_term>
    <mesh_term>Gliclazide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01679899
org study id: BoneGlyc
nct id: NCT01679899
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Markers of bone remodeling
time frame: 6 months
description: 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:
Osteocalcin (OC)
Bone-specific alkaline phosphatase (BALP)
Carboxy-terminal telopeptide of type I collagen (CTX)
Amino-terminal telopeptide of type I collagen (NTX)
measure: Bone mineral density of lumbar spine and femur by X-ray absorptiometry
time frame: 12 months
description: 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.
measure: Glycemic variability
time frame: 6 months
description: 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
measure: Calcitonin
time frame: 12 months
description: Dosage of serum calcitonin
measure: Levels of aminotransferases
time frame: 6 months
description: Dosage of alanine aminotransferase (ALT, SGOT) and aspartate aminotransferase (AST, SGPT)
arm group label: Vildagliptin
arm group type: Experimental
description: Vildagliptin 50 mg bid for 12 months
arm group label: Gliclazide MR
arm group type: Active Comparator
description: Gliclazide MR 60 or 120mg once a day for 12 months
intervention type: Drug
intervention name: Vildagliptin
description: Vildagliptin 50mg bid orally for 12 months
arm group label: Vildagliptin
other name: Galvus
intervention type: Drug
intervention name: Gliclazide MR
description: Gliclazide MR 60 or 120mg orally for 12 months
arm group label: Gliclazide MR
other name: Diamicron MR
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Andre GD Vianna, MD
role: Study Chair
affiliation: Centro de Diabetes Curitiba
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Osteoporosis
mesh term: Bone Diseases, Metabolic
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Vildagliptin
mesh term: Gliclazide
sharing ipd: No