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

NCT01679899 | Completed Phase 4

• 1 other identifier: BoneGlyc
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus; Menopause; Osteoporosis; Osteopenia

Keywords

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

Outcome Measures

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)

  6 months

Secondary Outcomes (3)

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

  12 months

• Glycemic variability

  6 months

• Calcitonin

  12 months

Other Outcomes (1)

• Levels of aminotransferases

  6 months

Study Arms (2)

Vildagliptin

EXPERIMENTAL

Vildagliptin 50 mg bid for 12 months

Drug: Vildagliptin

Gliclazide MR

ACTIVE COMPARATOR

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

Drug: Gliclazide MR

Interventions

Vildagliptin DRUG

Vildagliptin 50mg bid orally for 12 months

Also known as: Galvus

Vildagliptin

Gliclazide MR DRUG

Gliclazide MR 60 or 120mg orally for 12 months

Also known as: Diamicron MR

Gliclazide MR

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro de Diabetes Curitiba Ltda: lead

Study Sites (1)

Centro de Diabetes Curitiba

Curitiba, Paraná, 80810040, Brazil

Location

Related Publications (1)

• 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.

  PMID: 28515791 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Osteoporosis; Bone Diseases, Metabolic; Diabetes Mellitus

Interventions

Vildagliptin; Gliclazide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Sulfonylurea Compounds; Urea; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Andre GD Vianna, MD

  Centro de Diabetes Curitiba

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2012
• First Posted: September 6, 2012
• Study Start: December 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 4, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)