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CompletedNCT01679899BoneGlycUpdated Nov 4, 2016

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

A Phase 4 interventional study of Vildagliptin and Gliclazide MR in Type 2 Diabetes Mellitus, Menopause and Osteoporosis, sponsored by Centro de Diabetes Curitiba Ltda. Completed at 1 site in Brazil. Open to female participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-11-04.

Sponsored by Centro de Diabetes Curitiba Ltda · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus
  • Menopause
  • Osteoporosis
  • Osteopenia

Keywords

  • diabetes
  • type 2 diabetes mellitus
  • osteopenia
  • osteoporosis
  • glycemic variability
  • bone markers
  • osteocalcin
  • NTX
  • CTX
  • BALP
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 56 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Centro de Diabetes Curitiba Ltda is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    Vildagliptin

    Vildagliptin 50 mg bid for 12 months

    Drug: Vildagliptin

  • Active comparator
    Gliclazide MR

    Gliclazide MR 60 or 120mg once a day for 12 months

    Drug: Gliclazide MR

Interventions

  • DrugVildagliptin

    Vildagliptin 50mg bid orally for 12 months

    Also known as: Galvus

  • DrugGliclazide MR

    Gliclazide MR 60 or 120mg orally for 12 months

    Also known as: Diamicron MR

06

What researchers measure

Primary outcomes

  1. Markers of bone remodeling

    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)

    Time frame: 6 months

Secondary outcomes

  1. Bone mineral density of lumbar spine and femur by X-ray absorptiometry

    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.

    Time frame: 12 months

  2. Glycemic variability

    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

    Time frame: 6 months

  3. Calcitonin

    Dosage of serum calcitonin

    Time frame: 12 months

Other outcomes

  1. Levels of aminotransferases

    Dosage of alanine aminotransferase (ALT, SGOT) and aspartate aminotransferase (AST, SGPT)

    Time frame: 6 months

07

Study locations

1 site
  • Centro de Diabetes Curitiba
    Curitiba, Parana 80810040, Brazil
08

References and documents

Publications

  • Vianna AGD, de Lacerda CS, Pechmann LM, Polesel MG, Marino EC, Borba VZC, Barreto FC. Vildagliptin has the same safety profile as a sulfonylurea on bone metabolism and bone mineral density in post-menopausal women with type 2 diabetes: a randomized controlled trial. Diabetol Metab Syndr. 2017 May 15;9:35. doi: 10.1186/s13098-017-0232-2. eCollection 2017. PubMed 28515791 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01679899
Lead sponsor
Centro de Diabetes Curitiba Ltda
Responsible party
Sponsor
First posted
Sep 6, 2012
Start date
Dec 2012
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Nov 4, 2016

Study contacts

Andre GD Vianna, MD
study chair · Centro de Diabetes Curitiba

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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