GLP-1 Peptide Atlas, by Delfa

UnknownPhase 1

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

Lead sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Asset

Noiiglutide / HS-20004 / SHR20004

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Type 2 diabetes

Key I/E criteria

•BMI 18.5-30•HbA1c 6-9%

Primary endpoint

•Number of Treatment Emergent Adverse Events(TEAEs)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02750007

Org study IDHS-20004-Id

Timeline

Milestones

Study first posted2016-04-25estimated

Last update posted2016-04-25estimated

Study start2015-12 (month precision)

Primary completion2017-01estimated (month precision)

Assets

Investigational agents

Noiiglutide / HS-20004 / SHR20004

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Glycemic / diabetes

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Mean Change From Baseline in Body Weight at different dose steps