A Multicenter Randomized, Double-blind, Placebo and Positive Controlled ,Parallel Group ,Phase II Study to Access the Efficacy and Safety of SP2086 Treated Type 2 Diabetes Patients

Jiangsu HengRui Medicine Co., Ltd.1 个研究点分布在 1 个国家目标入组 200 人2011年6月

适应症Type 2 Diabetes

干预措施Placebo 50 mg SP2086 100 mg SP2086 200 mg SP2086 100 mg Sitagliptin

概览

阶段: 2 期
干预措施: Placebo
疾病 / 适应症: Type 2 Diabetes
发起方: Jiangsu HengRui Medicine Co., Ltd.
入组人数: 200
试验地点: 1
主要终点: the change from baseline in HbA1c at 12 week
状态: 已完成
最后更新: 12年前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

SP2086 is a new dipeptidy1 peptidase(DPP)-4 inhibitors. This study aims to explore the effective dose range of SP2086 in Patients with type 2 diabetes.

注册库

clinicaltrials.gov

开始日期

2011年6月

结束日期

2012年6月

最后更新

12年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Jiangsu HengRui Medicine Co., Ltd.

责任方

Sponsor

入排标准

入选标准

•20 Years to 70 Years ,Male and Female diagnosed with type 2 diabetes mellitus
•Patients not on an oral antihyperglycemic agent (OHA) with 7.0% ≤HbA1C ≤10.5%,or not on an OHA for 3 months with 7.0% ≤HbA1C ≤10.5%
•BMI 19\~35 kg/m2

排除标准

•Patient has history of type 1 diabetes mellitus
•Patient has history of ketoacidosis
•Patient has history of severe unconscious hypoglycemosis
•Patient has history of acute and chronic pancreatitis or pancreatic injury that may lead to high risk of pancreatitis
•Patient has history of decompensated heart failure (NYHA class III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, persistence and clinical
•Patient has history of a history of hypertension, and after antihypertensive treatment, systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg
•Patient has severe liver or kidney disease,alanine aminotransferase \>2×UNL, Aspartate Aminotransferase \>2×upper normal limit(UNL)；total bilirubin \>2×UNL； creatinine\>1.5 mg/dL (Male,132.6μmol/L) ，\>1.4 mg/dL(Female，123.8μmol/L)
•Patient has severe chronic gastrointestinal disease or therapy that may affect drug absorption, such as gastrointestinal surgery
•Patient has severe haematological diseases or other diseases leading to hemolyze and red blood cell unstable (malaria、haemolytic anaemia eg. )
•Patient has other endocrine diseases, for example hyperthyroidism、hypothyroidism、hypercortisolism、multiple endocrine neoplasia and so on

研究组 & 干预措施

Placebo

干预措施: Placebo

50 mg SP2086

干预措施: 50 mg SP2086

100 mg SP2086

干预措施: 100 mg SP2086

200 mg SP2086

干预措施: 200 mg SP2086

100 mg Sitagliptin

干预措施: 100 mg Sitagliptin

结局指标

主要结局

the change from baseline in HbA1c at 12 week

时间窗: baseline, week 12

次要结局

Post-meal total and incremental glucose,insulin and C-peptide area under the curve at week 4 ,12(baseline, week 4 ,12)
Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels(week 12)
Change From Baseline in Fasting Plasma Glucose at Week 4, 8 and 12(Baseline, Week 4, 8, 12)
Change from baseline in Homeostasis model assessment-beta(HOMA-β) at week 4,week12(baseline, week 4,12week)
Change From Baseline in lipid at Week 4, 8 and 12(baseline, week 4, 8, 12)
Change From Baseline in Body Weight at Week 4,8,12(baseline, Week 4, 8,12)