Effect of Anti-diabetic Drugs on Bone Metabolism and Glycemic Variability.A Comparison Between Vildagliptin and Gliclazide MR
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Markers of bone remodeling
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Vildagliptin
Vildagliptin 50 mg bid for 12 months
干预措施: Vildagliptin (Drug)
Gliclazide MR
Gliclazide MR 60 or 120mg once a day for 12 months
干预措施: Gliclazide MR (Drug)
结局指标
主要结局
Markers of bone remodeling
时间窗: 6 months
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)
次要结局
- Calcitonin(12 months)
- Bone mineral density of lumbar spine and femur by X-ray absorptiometry(12 months)
- Glycemic variability(6 months)