A Long-Term, Open-Label Extension Study to Investigate the Long-Term Safety of SYR110322 (SYR-322) in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,323
- 主要终点
- Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety of alogliptin, once daily (QD), following participation in 1 of 7 controlled studies in patients with type 2 diabetes mellitus.
详细描述
SYR-322 (alogliptin) is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion, namely glucagon-like peptide-1 and glucose-dependent insulinotropic peptide. It is expected that inhibition of dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2 diabetes mellitus by prolonging the beneficial effects of glucagon-like peptide-1.
The rising incidence of type 2 diabetes mellitus and the limitations of the currently available treatments suggest the need for new therapies for glycemic control. Studies have been undertaken in humans that evaluated the effects of directly augmenting glucagon-like peptide-1 and glucose-dependent insulinotropic peptide levels and of inhibiting the activity of dipeptidyl peptidase IV.
This study is an extension of 7 controlled phase 3 studies of alogliptin. These phase 3 studies included 1 monotherapy study of alogliptin (SYR-322-PLC-010; NCT00286455); 4 placebo-controlled add-on studies of alogliptin, namely in combination with a sulfonylurea (SYR-322-SULF-007; NCT00286468), metformin (SYR-322-MET-008; NCT00286442), a thiazolidinedione (pioglitazone; SYR-322-TZD-009; NCT00286494), and insulin (SYR-322-INS-011; NCT00286429); 1 coadministration study with pioglitazone in combination with metformin (01-05-TL-322OPI-001; NCT00328627), and 1 coadministration study with pioglitazone (01-06-TL-322OPI-002; NCT00395512).
The end of treatment or early withdrawal visit from the preceding study will be the screening visit for this study, after which enrolled patients will be required to commit to approximately 22 additional visits at the study center.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- •Type 2 diabetes mellitus and was enrolled in one of the following 7 controlled Phase III studies. The study will be open to all patients who completed one of these studies through the end-of-treatment visit:
- •SYR-322-PLC-010 - NCT00286455
- •SYR-322-SULF-007 - NCT00286468
- •SYR-322-MET-008 - NCT00286442
- •SYR-322-TZD-009 - NCT00286494
- •SYR-322-INS-011 - NCT00286429
- •01-05-TL-322OPI-001 - NCT00328627
- •01-06-TL-322OPI-002 - NCT00395512
- •Alanine aminotransferase less than or equal to 3 times the upper limit of normal and serum creatinine less than or equal to 2.0 mg per dL.
- •Able and willing to monitor own blood glucose concentrations with a home glucose monitor.
- •No major illness or debility that in the investigator's opinion prohibits the patient from completing the study.
- •Exclusion Criteria
- •The occurrence of any adverse event or condition during the controlled Phase III studies, which, in the opinion of the investigator, should exclude the patient from participating in the open-label extension.
- •Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
- •Weight-loss drugs
- •Investigational antidiabetics, additional dipeptidyl peptidase-4 (DPP-4) and glucagon-like peptide-1 (GLP 1) inhibitors
- •Incretin Mimetics,
- •Oral or systemically injected glucocorticoids.
排除标准
- 未提供
研究组 & 干预措施
Alogliptin 12.5 mg
Alogliptin 12.5 tablet, orally, once daily for up to 4 years.
干预措施: Alogliptin (Drug)
Alogliptin 25 mg
Alogliptin 25 mg tablet, orally, once daily for up to 4 years.
干预措施: Alogliptin (Drug)
结局指标
主要结局
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
时间窗: 4 years
Safety was assessed by physical examinations, clinical laboratory parameters, electrocardiogram (ECG) readings, vital sign measurements, oral temperature, and hypoglycemic events. Changes in laboratory values or ECG parameters were considered to be adverse events if they were judged to be clinically significant. A TEAE was any event that started on or after the first dose of open-label study drug and within 14 days after the last dose.
次要结局
- Change From Baseline Over Time in Glycosylated Hemoglobin(Baseline and Month 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42 and 45.)
- Change From Baseline in Fasting Plasma Glucose(Baseline and Year 4)
- Percentage of Participants With Marked Hyperglycemia(Randomization up to 4 years.)
- Change From Baseline in Proinsulin Level(Baseline and Year 4)
- Change From Baseline in Insulin Level(Baseline and Year 4)
- Change From Baseline in C-peptide Level(Baseline and Year 4)
- Change From Baseline in Body Weight(Baseline and Year 4)
- Percentage of Participants With a Clinical Response(Weeks 2, 4, 8, 12, every 3 months up to 4 years, and 1 Day after final dose.)