Type 2 Diabetes
Conditions
Keywords
Sp2086, Phase II, monotherapy
Brief summary
SP2086 is a new dipeptidy1 peptidase(DPP)-4 inhibitors. This study aims to explore the effective dose range of SP2086 in Patients with type 2 diabetes.
Interventions
DRUGPlacebo
Tablets(n=4),once daily for 84 days
DRUG50 mg SP2086
Tablets(n=1),50mg strength+tablets(n=3) 0 mg once daily for 84 days
DRUG100 mg SP2086
Tablets(n=1),100 mg strength+tablets(n=3) once 0 mg daily for 84 days
DRUG200 mg SP2086
Tablets(n=2),100 mg strength+tablets(n=2) 0mg once daily for 84 days
DRUG100 mg Sitagliptin
Tablets(n=1),100 mg strength+tablets(n=3),0 mg strength once daily for 84 days
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 20 Years to 70 Years ,Male and Female diagnosed with type 2 diabetes mellitus * Patients not on an oral antihyperglycemic agent (OHA) with 7.0% ≤HbA1C ≤10.5%,or not on an OHA for 3 months with 7.0% ≤HbA1C ≤10.5% * BMI 19\ 35 kg/m2
Exclusion criteria
* Patient has history of type 1 diabetes mellitus * Patient has history of ketoacidosis * Patient has history of severe unconscious hypoglycemosis * Patient has history of acute and chronic pancreatitis or pancreatic injury that may lead to high risk of pancreatitis * Patient has history of decompensated heart failure (NYHA class III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, persistence and clinical * Patient has history of a history of hypertension, and after antihypertensive treatment, systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg * Patient has severe liver or kidney disease,alanine aminotransferase \>2×UNL, Aspartate Aminotransferase \>2×upper normal limit(UNL)；total bilirubin \>2×UNL； creatinine\>1.5 mg/dL (Male,132.6μmol/L) ，\>1.4 mg/dL(Female，123.8μmol/L) * Patient has severe chronic gastrointestinal disease or therapy that may affect drug absorption, such as gastrointestinal surgery * Patient has severe haematological diseases or other diseases leading to hemolyze and red blood cell unstable (malaria、haemolytic anaemia eg. ) * Patient has other endocrine diseases, for example hyperthyroidism、hypothyroidism、hypercortisolism、multiple endocrine neoplasia and so on * Patient has history of malignancy * Patient has history of alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the change from baseline in HbA1c at 12 week | baseline, week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in Fasting Plasma Glucose at Week 4, 8 and 12 | Baseline, Week 4, 8, 12 |
| Post-meal total and incremental glucose,insulin and C-peptide area under the curve at week 4 ,12 | baseline, week 4 ,12 |
| Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels | week 12 |
| Change From Baseline in lipid at Week 4, 8 and 12 | baseline, week 4, 8, 12 |
| Change From Baseline in Body Weight at Week 4,8,12 | baseline, Week 4, 8,12 |
| Change from baseline in Homeostasis model assessment-beta(HOMA-β) at week 4,week12 | baseline, week 4,12week |
Countries
China
Outcome results
None listed