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

NCT02750007 | Unknown Phase 1

• 1 other identifier: HS-20004-Id
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of Treatment Emergent Adverse Events(TEAEs)

  through study completion, an maximum of 8 weeks

Secondary Outcomes (7)

• Number of Nausea and vomiting during titration

  through study completion, an maximum of 8 weeks

• Mean Change From Baseline in Body Weight at different dose steps

  through study completion, an maximum of 8 weeks

• Change in plasma concentration of HS-20004 from baseline at different dose steps

  through study completion, an maximum of 8 weeks

• Change in plasma concentration of glucose from baseline at different dose steps

  through study completion, an maximum of 8 weeks

• Change in plasma concentration of insulin from baseline at different dose steps

  through study completion, an maximum of 8 weeks

Study Arms (1)

Experimental

EXPERIMENTAL

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

Drug: HS-20004

Interventions

HS-20004 DRUG

Experimental

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Zhiguang - Zhou

CONTACT

0731-85292097; zhouzg@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 25, 2016
• Study Start: December 1, 2015
• Primary Completion: January 1, 2017
• Last Updated: April 25, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)