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

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ClinicalTrials.gov Identifier: NCT02750007
Recruitment Status : Unknown
Verified April 2016 by Jiangsu Hansoh Pharmaceutical Co., Ltd..
Recruitment status was:  Recruiting
First Posted : April 25, 2016
Last Update Posted : April 25, 2016
Sponsor:
Information provided by (Responsible Party):
Jiangsu Hansoh Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: HS-20004 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2015
Estimated Primary Completion Date : January 2017

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



Primary Outcome Measures :
  1. Number of Treatment Emergent Adverse Events(TEAEs) [ Time Frame: through study completion, an maximum of 8 weeks ]

Secondary Outcome Measures :
  1. Number of Nausea and vomiting during titration [ Time Frame: through study completion, an maximum of 8 weeks ]
  2. Mean Change From Baseline in Body Weight at different dose steps [ Time Frame: through study completion, an maximum of 8 weeks ]
  3. Change in plasma concentration of HS-20004 from baseline at different dose steps [ Time Frame: through study completion, an maximum of 8 weeks ]
  4. Change in plasma concentration of glucose from baseline at different dose steps [ Time Frame: through study completion, an maximum of 8 weeks ]
  5. Change in plasma concentration of insulin from baseline at different dose steps [ Time Frame: through study completion, an maximum of 8 weeks ]
  6. Change in plasma concentration of glucagon from baseline at different dose steps [ Time Frame: through study completion, an maximum of 8 weeks ]
  7. 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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750007


Contacts
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Contact: Zhiguang - Zhou 0731-85292097 zhouzg@hotmail.com

Locations
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China, Hunan
The Second Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China, 410011
Contact: Zhiguang Zhou, Professor    0731-85292097    zhouzg@hotmail.com   
Sponsors and Collaborators
Jiangsu Hansoh Pharmaceutical Co., Ltd.

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Responsible Party: Jiangsu Hansoh Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02750007     History of Changes
Other Study ID Numbers: HS-20004-Id
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: April 25, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases