Tolerability to HS-20004 With Titration Administration in Type 2 Diabetic Patients

NCT ID: NCT02750007

Last Updated: 2016-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31

Brief Summary

This study is conducted in China. The aim of this trial is to assess the tolerability to HS-20004 with titration administration in type 2 diabetic patients.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

Weekly-dose titration from 0.04mg/day HS-20004 to the maximum tolerable dose or of the ultimate 0.18mg/day

Group Type: EXPERIMENTAL

HS-20004

Intervention Type: DRUG

Interventions

HS-20004

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Type 2 diabetes diagnosed for more than 3 months;
• HbA1c between ≥6.0 and ≤9.0 %, and FPG between ≥7.0 and ≤13.9 mmol/L;
• Body Mass Index (BMI) between 18.5 and 30 kg/m^2 (inclusive) with a total body weight of at least 50 kg;
• Agree to stop any other drugs for diabetes during washout and study period;

Exclusion Criteria

• Treatment of GLP-1 analogues, DPP-IV enzyme inhibitors or other analogues before;
• History or family history of drug allergy;
• Smoker or alcohol abuse;
• Currently use or plan to use systemic corticosteroid;
• History of recurrent severe hypoglycemia;
• History of proliferative retinopathy or maculopathy which required acute treatment;
• Impaired hepatic or renal function, or cardiac problem;
• Uncontrolled active or untreated hypertension;
• Family history of thyroid cancer or submandibular gland cancer, or past history of pancreatitis, cholelithiasis, or serious unconscious hypoglycemia history;
• Positive of hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody;
• Subject has participated in any investigational study within 3 months, or is currently participating in another clinical study;
• Female subject of childbearing potential who does not use an acceptable method of birth control, is pregnant or planning a pregnancy, or breastfeeding, or male subject who does not use an acceptable method of birth control, within six months before randomization; Subject who cannot refrain from smoking, eating and/or drinking containing xanthine/caffeine, or strenuous exercise, or others that affect drug absorption, distribution, metabolism and excretion within 2 days before the study drug administration;
• Have any other medical abnormality (such as cardiovascular, hepatic, renal, gastrointestinal, immunologic, hematological, hormonal, metabolic, neoplasmatic or mental disease), which in the opinion of the investigator, might affect the absorption, distribution, metabolism, and excretion of the study drug, or prevent the patient from following and completing the protocol；
• Subject was not used for the study as determined by the Investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhiguang - Zhou

Role: CONTACT

zhouzg@hotmail.com

0731-85292097

Facility Contacts

Zhiguang Zhou, Professor

Role: primary

zhouzg@hotmail.com

0731-85292097

Other Identifiers

HS-20004-Id

Identifier Type: -

Identifier Source: org_study_id