Back to resultsTolerability to HS-20004 With Titration Administration in Type 2 Diabetic Patients
Primary Purpose
Diabetes Mellitus, Type 2
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HS-20004
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
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.
Sites / Locations
- The Second Xiangya Hospital of Central South UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Weekly-dose titration from 0.04mg/day HS-20004 to the maximum tolerable dose or of the ultimate 0.18mg/day
Outcomes
Primary Outcome Measures
Number of Treatment Emergent Adverse Events(TEAEs)
Secondary Outcome Measures
Number of Nausea and vomiting during titration
Mean Change From Baseline in Body Weight at different dose steps
Change in plasma concentration of HS-20004 from baseline at different dose steps
Change in plasma concentration of glucose from baseline at different dose steps
Change in plasma concentration of insulin from baseline at different dose steps
Change in plasma concentration of glucagon from baseline at different dose steps
The minimum dose of HS-20004 that could keep plasma glucose under 6.1 mmol/L in Type 2 Diabetic Patients
Full Information
NCT ID
NCT02750007
First Posted
April 11, 2016
Last Updated
April 22, 2016
Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02750007
Brief Title
Tolerability to HS-20004 With Titration Administration in Type 2 Diabetic Patients
Official Title
Open-label, Non-randomized, Weekly-dose Titration Study to Assess the Tolerability to HS-20004 in Type 2 (Diabetes Mellitus) Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Weekly-dose titration from 0.04mg/day HS-20004 to the maximum tolerable dose or of the ultimate 0.18mg/day
Intervention Type
Drug
Intervention Name(s)
HS-20004
Primary Outcome Measure Information:
Title
Number of Treatment Emergent Adverse Events(TEAEs)
Time Frame
through study completion, an maximum of 8 weeks
Secondary Outcome Measure Information:
Title
Number of Nausea and vomiting during titration
Time Frame
through study completion, an maximum of 8 weeks
Title
Mean Change From Baseline in Body Weight at different dose steps
Time Frame
through study completion, an maximum of 8 weeks
Title
Change in plasma concentration of HS-20004 from baseline at different dose steps
Time Frame
through study completion, an maximum of 8 weeks
Title
Change in plasma concentration of glucose from baseline at different dose steps
Time Frame
through study completion, an maximum of 8 weeks
Title
Change in plasma concentration of insulin from baseline at different dose steps
Time Frame
through study completion, an maximum of 8 weeks
Title
Change in plasma concentration of glucagon from baseline at different dose steps
Time Frame
through study completion, an maximum of 8 weeks
Title
The minimum dose of HS-20004 that could keep plasma glucose under 6.1 mmol/L in Type 2 Diabetic Patients
Time Frame
through study completion, an maximum of 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiguang - Zhou
Phone
0731-85292097
Email
zhouzg@hotmail.com
Facility Information:
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiguang Zhou, Professor
Phone
0731-85292097
Email
zhouzg@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Tolerability to HS-20004 With Titration Administration in Type 2 Diabetic Patients
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