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

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Hansoh Pharma

Status and phase

Unknown
Phase 1

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: HS-20004

Study type

Interventional

Funder types

Industry

Identifiers

NCT02750007
HS-20004-Id

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

Experimental
Experimental group
Description:
Weekly-dose titration from 0.04mg/day HS-20004 to the maximum tolerable dose or of the ultimate 0.18mg/day
Treatment:
Drug: HS-20004

Trial contacts and locations

1

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Central trial contact

Zhiguang - Zhou

Data sourced from clinicaltrials.gov

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