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

Open-label, Non-randomized, Weekly-dose Titration Study to Assess the Tolerability to HS-20004 in Type 2 (Diabetes Mellitus) Diabetic Patients

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: HS-20004

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Zhiguang - Zhou; Phone Number: 0731-85292097; Email: zhouzg@hotmail.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410011
      • Recruiting
      • The Second Xiangya Hospital Of Central South University
      • Contact: Zhiguang Zhou, Professor; Phone Number: 0731-85292097; Email: zhouzg@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Treatment Emergent Adverse Events(TEAEs)	through study completion, an maximum of 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Change in plasma concentration of glucagon from baseline at different dose steps	through study completion, an maximum of 8 weeks
The minimum dose of HS-20004 that could keep plasma glucose under 6.1 mmol/L in Type 2 Diabetic Patients	through study completion, an maximum of 8 weeks

Collaborators and Investigators

• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: April 11, 2016
• First Submitted That Met QC Criteria: April 22, 2016
• First Posted (Estimate): April 25, 2016

Study Record Updates

• Last Update Posted (Estimate): April 25, 2016
• Last Update Submitted That Met QC Criteria: April 22, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: HS-20004-Id

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO