NCT01862263终止4 期
A Multicenter, Double-Blind, Randomized, Parallel-Group Placebo-Controlled Study to Compare the Effect of 13-Week Treatment With Vildagliptin as Add-On Therapy to Improve Glucose Variability in Type 2 Diabetes Mellitus Patients Inadequately Controlled With Insulin.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 191
- 试验地点
- 1
- 主要终点
- Percentage of patients with hyperglycemic events evaluated with CGM
研究概览
简要总结
The purpose of the study is to assess if the addition of vildagliptin as add-on therapy improves glucose variability in type 2 diabetes mellitus (T2DM) patients inadequately controlled with insulin, with special emphasis in hypoglycemic episodes measured by continuous glucose monitoring.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent read and signed before any protocol procedure.
- •Free will to sign the informed consent.
- •Male and female between 18 and 80 years. If female, patient must be non-fertile or of childbearing potential using a medically approved birth control method.
- •Type 2 diabetes mellitus
- •Patient under insulin treatment within 3 years with stable insulin NPH (Neutral ProtamineHagedorn) regimen at dose of at least 20 UI/day up to 40 UI/day for a minimum of 4 weeks prior to enrolment, only NPH and glargine insulin are allowed.
- •HbA1c between 7.5 to 9%.
- •Fasting plasma glucose (FPG) less than 270 mg/dL.
- •Body mass index (BMI) between 20 to 35 kg/m
- •Free willing to take the vildagliptin tablets during the study.
- •Exclusion Criteria
- •Pregnant or lactating female or without birth control method if of childbearing potential.
- •Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing's syndrome.
- •Acute cardiovascular complications or metabolic complications within the past 4 months.
- •History cerebrovascular disease during the last year.
- •History of Torsades de Points, ventricular tachycardia or ventricular fibrillation.
- •Ischemic heart disease (e.g. myocardial infarction, unstable angina, coronary artery bypass surgery).
- •Congestive heart failure requiring pharmacologic treatment.
- •Any known serious heart condition.
- •ALT and/or AST greater than three times the upper limit of the normal range.
- •Serum creatinine levels greater than 1.5 mg/dL
- •Malignancy including leukemia and lymphoma within the last 5 years
- •Other inlcusion/exclusion criteria may apply
排除标准
- 未提供
研究组 & 干预措施
Vildagliptin
Experimental
Vildagliptin 50 mg twice daily (bid) + Insulin 20 to 40 IU/day
干预措施: Vildagliptin (Drug)
Vildagliptin
Experimental
Vildagliptin 50 mg twice daily (bid) + Insulin 20 to 40 IU/day
干预措施: Insulin (Drug)
Placebo
Placebo Comparator
Insulin 20 to 40 IU/day + Vildagliptin Placebo twice daily (bid)
干预措施: Insulin (Drug)
Placebo
Placebo Comparator
Insulin 20 to 40 IU/day + Vildagliptin Placebo twice daily (bid)
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of patients with hyperglycemic events evaluated with CGM
时间窗: At 13 weeks
An hypoglycemic event is defined as any continuous glucose monitoring (CGM) measurement less than 60 mg/dL and a hyperglycemic is define as any CGM greater than 140 mg/dL.
次要结局
- Number of hypoglycemia and/or hyperglycemia measured by CGM(13 weeks)
- Area under the curve (AUC 0-24) of the excursions of glucose values below 60 mg/dl per day(0 to 24 hours daily for week 1, 4 and 13)
- Average of insulin units per day administered during the study(13 weeks)
- Changes from the baseline in Lipid Profile(Baseline, 13 weeks)
- Change from baseline in Body weight(Baseline, 13 weeks)
- Change from baseline in Blood pressure (BP),(Baseline, 13 weeks)
- Change from baseline in Fasting plasma glucose (FPG),(Baseline, 13 weeks)
- Change from baseline in Hemoglobin A1C (HbA1c)(Baseline, 13 weeks)
- Change from baseline in Creatinine(Baseline, 13 weeks)
- Change from baseline in C-peptide(Baseline, 13 weeks)
- Changes from baseline in alanine aminotransferase (ALT)/aspartate aminotransferase (AST)(Baseline, 13 week)
- Changes from baseline in Direct bilirubin(Baseline, 13 weeks)
- Changes from baseline in Body Mass Index (BMI)(Baseline, 13 weeks)
- Number of patients with adverse events, serious adverse events and death as evaluation of safety and tolerability of coadministration of vildagliptin with insulin(13 weeks)
研究者
研究点 (1)
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