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Type 2 Diabetes MellitusPhase 4BoneGlycNCT01679899

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

A Phase 4 study testing Vildagliptin and Gliclazide MR in people with Type 2 Diabetes Mellitus and Menopause, run by Centro de Diabetes Curitiba Ltda at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 75 years, women only
Conditions the study is for
Type 2 Diabetes Mellitus, Menopause, Osteoporosis
What is being tested?
Vildagliptin and Gliclazide MR
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteBrazil
Study dates
Dec 2012to Oct 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 21Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Centro de Diabetes Curitiba

    Curitiba, Paraná, 80810040

Other trials in Brazil

About this study

Official title: Effect of Anti-diabetic Drugs on Bone Metabolism and Glycemic Variability.A Comparison Between Vildagliptin and Gliclazide MR

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.

Being tested
Vildagliptin, Gliclazide MR
Keywords
diabetes, type 2 diabetes mellitus, osteopenia, osteoporosis, glycemic variability, bone markers, osteocalcin, NTX, CTX, BALP
Medical subject headings
Diabetes Mellitus, Type 2, Osteoporosis, Bone Diseases, Metabolic, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VildagliptinDrug

    Also called Galvus

    Vildagliptin 50mg bid orally for 12 months

  • Gliclazide MRDrug

    Also called Diamicron MR

    Gliclazide MR 60 or 120mg orally for 12 months

Study groups in NCT01679899
Study groupRoleWhat they receive
VildagliptinExperimentalVildagliptin 50 mg bid for 12 months
Receives: Drug: Vildagliptin
Gliclazide MRActive comparatorGliclazide MR 60 or 120mg once a day for 12 months
Receives: Drug: Gliclazide MR

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 6 months

Secondary outcomes (3)

  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.

    Measured: 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

    Measured: 6 months

  3. Calcitonin

    Dosage of serum calcitonin

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionOct 2015
  4. Study completionOct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01679899
Sponsor's protocol ID
BoneGlyc
Acronym
BoneGlyc
Status last verified
Nov 2016
First submitted
2 Sep 2012
Last updated
4 Nov 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vildagliptin and Gliclazide MR in people with Type 2 Diabetes Mellitus and Menopause, run by Centro de Diabetes Curitiba Ltda at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Markers of bone remodeling (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01679899, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2016.

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