A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Two-Staged, Fixed Design Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of P2202 in Overweight/Obese Patients of Type 2 Diabetes Mellitus Inadequately Controlled on Metformin, Sulphonylurea, or Both.
试验速览
- 阶段
- 2 期
- 状态
- Other
- 发起方
- 入组人数
- 698
- 试验地点
- 14
- 主要终点
- HbA1c
研究概览
简要总结
Type 2 diabetes mellitus, the commonest form of diabetes, is an increasing global health burden and affects 285 million people globally, between 20 and 79 years of age and 50.8 million people in the same age group in xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /India. This incidence is projected to increase to 438 million globally and to 87.0 million in India by the year 2030. It is characterized by insulin secretory dysfunction and peripheral tissue insulin resistance, which lead to increased hepatic glucose output and decreased glucose uptake in skeletal muscle and adipose tissues. Treatment of type 2 diabetes mellitus is primarily aimed at lowering insulin resistance and increasing the function of beta cells. Diabetic patients are prone to suffer from increased cardiovascular mortality due to attendant risk factors of dyslipidemia, hypertension and obesity. Oral agents are often used with or without insulin therapy to achieve good metabolic control, assessed from the measurement of glycated hemoglobin (HbA1c), fasting and post-prandial plasma glucose.
P2202 is a novel oral drug with potent and selective 11 beta-hydroxysteroid dehydrogenase type 1 (11 beta HSD1) inhibitory properties, being developed for the management of type 2 diabetes mellitus and possibly metabolic syndrome. A battery of in vitro and in vivo tests has been performed with P2202 to study its pharmacological, pharmacokinetic (PK) and toxicity profiles.
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研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult male and females between 18 years to 65 years of age with a BMI more than or equal to 27 kg/m2 but less than or equal to 40 kg/m2, inclusively.
- •Subjects with established type 2 diabetes mellitus Subjects with HbA1c level more than or equal to 7.5% and less than 10% at screening.
- •Subjects who are on a stable dose of Metformin and/or Sulfonylurea Subjects with fasting plasma glucose of less than or equal to 14.4 mmol/L and at least 5.5 mmol/L prior to randomization Subjects with a C-peptide value of > 0.299 nmol/L (0.9 ng/mL) at the screening visit Subjects with serum LDL-C more than or equal to 3.10 mmol/L and less than or equal to 4.89 mmol/L Subjects with serum triglycerides more than or equal to1.69 mmol/L and less than or equal to 6.76 mmol/L.
- •Non-surgically sterile male subjects with partner(s) of childbearing potential who must be must be willing to use contraception throughout the study and ensure that their partner(s) will use simultaneously effective means of contraception during this period.
- •Non-childbearing potential female subjects who have sexual intercourse with a non-sterile male partner will be advised to use an acceptable method of contraception throughout the study Negative pregnancy test at screening.
排除标准
- •Subjects with type 1 diabetes mellitus, maturity-onset diabetes of the young or any rare form of diabetes.
- •Subjects with hyperglycemia due to secondary causes or frequent hypoglycemic events Subjects with a history of acute diabetic complications prior to screening Subjects treated with insulin or other anti-diabetic agents prior to screening Subjects who received systemic glucocorticoids prior to screening Subjects with a history of clinically significant disease other than type 2 diabetes, which in the investigator’s opinion will disallow him/her from completing the current study Subjects with a history of uncontrolled hypertension or secondary hypertension Subjects with abnormal renal and hepatic function Subjects who have received any investigational new drug prior to screening.
结局指标
主要结局
HbA1c
时间窗: baseline and end of study visit.
次要结局
- fasting serum lipids(baseline and end of study)
- serum hsCRP(baseline and end of study)
- serum adiponectin and serum leptin(baseline and end of study visit.)
- fasting plasma glucose, fasting serum insulin and fasting serum C-peptide(baseline and end of study visit.)