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

Primary Purpose

Type 2 Diabetes Mellitus, Menopause, Osteoporosis

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Vildagliptin

Gliclazide MR

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring diabetes, type 2 diabetes mellitus, osteopenia, osteoporosis, glycemic variability, bone markers, osteocalcin, NTX, CTX, BALP

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Centro de Diabetes Curitiba

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vildagliptin

Gliclazide MR

Arm Description

Vildagliptin 50 mg bid for 12 months

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

Outcomes

Primary Outcome Measures

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: Osteocalcin (OC) Bone-specific alkaline phosphatase (BALP) Carboxy-terminal telopeptide of type I collagen (CTX) Amino-terminal telopeptide of type I collagen (NTX)

Secondary Outcome Measures

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.

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

Calcitonin

Dosage of serum calcitonin

Full Information

NCT ID

NCT01679899

First Posted

September 2, 2012

Last Updated

November 2, 2016

Sponsor

Centro de Diabetes Curitiba Ltda

1. Study Identification

Unique Protocol Identification Number

NCT01679899

Brief Title

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

Acronym

BoneGlyc

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centro de Diabetes Curitiba Ltda

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus, Menopause, Osteoporosis, Osteopenia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vildagliptin

Arm Type

Experimental

Arm Description

Vildagliptin 50 mg bid for 12 months

Arm Title

Gliclazide MR

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Vildagliptin

Other Intervention Name(s)

Galvus

Intervention Description

Vildagliptin 50mg bid orally for 12 months

Intervention Type

Drug

Intervention Name(s)

Gliclazide MR

Other Intervention Name(s)

Diamicron MR

Intervention Description

Gliclazide MR 60 or 120mg orally for 12 months

Primary Outcome Measure Information:

Title

Markers of bone remodeling

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

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.

Time Frame

12 months

Title

Glycemic variability

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

Time Frame

6 months

Title

Calcitonin

Description

Dosage of serum calcitonin

Time Frame

12 months

Other Pre-specified Outcome Measures:

Title

Levels of aminotransferases

Description

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

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andre GD Vianna, MD

Organizational Affiliation

Centro de Diabetes Curitiba

Official's Role

Study Chair

Facility Information:

Facility Name

Centro de Diabetes Curitiba

City

Curitiba

State/Province

Parana

ZIP/Postal Code

80810040

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28515791

Citation

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.

Results Reference

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

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