Postmarketing Clinical Study on AO-128
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 197
- 主要终点
- Assessment of Diabetic Status in the Treatment Period (Type 2 Diabetes Mellitus, Normoglycemia, or Impaired Glucose Tolerance (IGT)
研究概览
简要总结
The purpose of open-label study is to evaluate the efficacy and safety of AO-128 (Voglibose) 0.6 mg/day in patients with impaired glucose tolerance (IGT) who had been non-responsive to diet therapy and exercise therapy, and follow up the progress after the end of treatment in patients who was assessed as normoglycemic.
详细描述
The α-glucosidase inhibitor voglibose was developed by Takeda Pharmaceutical Co. Ltd and is one of the most commonly used oral antidiabetic agents in Japan. Voglibose is used as first-line treatment for improvement of postprandial hyperglycemia in diabetic patients with inadequate response to diet and exercise therapy and as add-on treatment to other oral antidiabetic drugs and insulin. In 2009, voglibose was approved in Japan for the management of prediabetes (IGT).
This study was a single-group, multi-center, open-label study. The study period consisted of a screening period of 1 week or less, a treatment period of 96 weeks or more, and a follow-up period of 48 weeks. However, if a patient was assessed as having type 2 diabetes mellitus or normoglycemia, the treatment period was to be ended, and only those assessed as normoglycemic were to proceed to follow-up. Follow-up was also to be terminated if patients were assessed as having IGT or type 2 diabetes mellitus during follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients on diet therapy and exercise therapy for 3 to 6 months prior to the start of screening, with baseline (fasting ) plasma glucose < 126 mg/dL and 2-hour plasma glucose of 140 to 199 mg/dL (revised WHO criteria) during a 75 g oral glucose tolerance test (OGTT) in the screening period
- •Patients meeting any of 1 through 4 below:
- •Comorbid hypertension or high normal blood pressure
- •Comorbid dyslipidemia
- •Comorbid obesity
- •Patients with up to a second-degree family history of type 2 diabetes mellitus
- •Patients with HbA1c < 6.5% in the screening period
- •Male or female patients at least 20 years of age at the time informed consent was obtained
- •Treatment category: Outpatient
排除标准
- •Patients previously diagnosed with diabetes mellitus.
- •Patients with apparent impaired glucose metabolism or with a disease or condition potentially involving impaired glucose metabolism.
- •Patients with serious hepatic impairment.
- •Patients with serious renal impairment.
- •Patients with serious cardiac, cerebrovascular, pancreatic, hematologic, or other disease.
- •Patients with a history of intestinal obstruction or a history of laparotomy within 6 months (24 weeks) before the start of screening.
研究组 & 干预措施
AO-128 0.6 mg
One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
干预措施: AO-128 (Drug)
结局指标
主要结局
Assessment of Diabetic Status in the Treatment Period (Type 2 Diabetes Mellitus, Normoglycemia, or Impaired Glucose Tolerance (IGT)
时间窗: Treatment period: Up to 122 weeks. Treatment was to be ended when patients were assessed as Type 2 Diabetes Mellitus or normoglycemic.
Frequency tabulations of the "assessment of diabetic status in the treatment period (Type 2 Diabetes mellitus, normoglycemia, or IGT)" were prepared in the "Full Analysis Set".
Assessment of Diabetic Status in Follow-up (Type 2 Diabetes Mellitus, Normoglycemia, or IGT)
时间窗: Follow-up at Week 12, 24, 36, and 48
Frequency tabulations of the "assessment of diabetic status in the follow-up (Type 2 Diabetes mellitus, normoglycemia, or IGT)" were prepared in patients who proceeded to the follow-up in the "Full Analysis Set".
次要结局
- Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated by the Kaplan-Meier Method(Day 168, 336, 504, and 672)
- Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated Using the Cumulative Incidence Function(Day 168, 336, 504, and 672)
- Time to Improvement to Normoglycemia in the Treatment Period Calculated by the Kaplan-Meier Method(Day 168, 336, 504, and 672)
- Time to Improvement to Normoglycemia in the Treatment Period Measured Values by the Cumulative Incidence Function(Day 168, 336, 504, and 672)
- 2-Hour Plasma Glucose During 75 g Oral Glucose Tolerance Test (OGTT)(Week 0, 24, 48, 72, 96, 120, and the end of the treatment period)
- 2-Hour Plasma Glucose During 75 g OGTT at Follow-up(Follow-up at week 0, 12, 24, 36, and 48)
- Hemoglobin A1c (HbA1c)(Week 0, 12, 24, 48, 72, 96, 120, and the end of the treatment period.)
- Body Weight at Follow-up(Follow-up at Week 0, 12, 24, 36, and 48)
- HbA1c at Follow-up(Follow-up at Week 0, 12, 24, 36, and 48)
- Body Weight(Week 0, 12, 24, 48, 72, 96, 120, and the end of the treatment period)