跳至主要内容
临床试验/NCT00071422
NCT00071422已完成2 期

A Randomized, Double-blind, Placebo-controlled, Rising-dose, Multicenter Study to Evaluate the Efficacy and Safety of 90 Days of 300 or 600 mg Daily Subcutaneous Injections of INGAP Peptide in Insulin-using Type 2 Diabetes Mellitus Patients

Exsulin Corporation16 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2003年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
126
试验地点
16

研究概览

简要总结

Insulin is a chemical that the body needs in order to use or store sugar. It is made by a type of cell called a beta cell which resides in an organ known as the pancreas. Type 2 diabetes is a disease where the beta cells are unable to meet a person's insulin needs. Sugar levels rise in the blood as a result. INGAP-Peptide is being tested to attempt to create new beta cells in the pancreas, and to improve the ability to produce insulin in type 2 diabetic patients.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
35 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

placebo

Placebo Comparator

1.5 mL SC injection, once daily for 90 days

干预措施: placebo (Drug)

300 mg INGAP Peptide

Experimental

1.5 mL SC injection, once daily for 90 days

干预措施: INGAP-Peptide (Drug)

600 mg INGAP Peptide

Experimental

1.5 mL SC injection, once daily for 90 days

干预措施: INGAP-Peptide (Drug)

研究者

申办方类型
Industry

研究点 (16)

Loading locations...

相似试验