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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02750007
• Other study ID #: HS-20004-Id
• Status: Recruiting
• Phase: Phase 1
• First received: April 11, 2016
• Last updated: April 22, 2016
• Start date: December 2015

Study information

• Verified date: April 2016
• Source: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Contact: Zhiguang - Zhou
• Phone: 0731-85292097
• Email: zhouzg[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• HS-20004

Locations

Country	Name	City	State
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Treatment Emergent Adverse Events(TEAEs)		through study completion, an maximum of 8 weeks	Yes
Secondary	Number of Nausea and vomiting during titration		through study completion, an maximum of 8 weeks	Yes
Secondary	Mean Change From Baseline in Body Weight at different dose steps		through study completion, an maximum of 8 weeks	No
Secondary	Change in plasma concentration of HS-20004 from baseline at different dose steps		through study completion, an maximum of 8 weeks	No
Secondary	Change in plasma concentration of glucose from baseline at different dose steps		through study completion, an maximum of 8 weeks	No
Secondary	Change in plasma concentration of insulin from baseline at different dose steps		through study completion, an maximum of 8 weeks	No
Secondary	Change in plasma concentration of glucagon from baseline at different dose steps		through study completion, an maximum of 8 weeks	No
Secondary	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	No