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

Type 2 Diabetes Mellitus Clinical Trial

— BoneGlyc  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01679899
• Other study ID #: BoneGlyc
• Status: Completed
• Phase: Phase 4
• First received: September 2, 2012
• Last updated: November 2, 2016
• Start date: December 2012
• Est. completion date: October 2015

Study information

• Verified date: November 2016
• Source: Centro de Diabetes Curitiba Ltda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Menopause
• Osteopenia
• Osteoporosis
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Vildagliptin
Vildagliptin 50mg bid orally for 12 months
• Gliclazide MR
Gliclazide MR 60 or 120mg orally for 12 months

Locations

Country	Name	City	State
Brazil	Centro de Diabetes Curitiba	Curitiba	Parana

Sponsors (1)

Lead Sponsor	Collaborator
Centro de Diabetes Curitiba Ltda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Levels of aminotransferases	Dosage of alanine aminotransferase (ALT, SGOT) and aspartate aminotransferase (AST, SGPT)	6 months	Yes
Primary	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)	6 months	No
Secondary	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.	12 months	No
Secondary	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	6 months	No
Secondary	Calcitonin	Dosage of serum calcitonin	12 months	Yes