A Study of the Effectiveness and Safety of SP2086 to Treat Type 2 Diabetes

Study Overview
=================
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.

Official Title
-----------------
A Multicenter Randomized, Double-blind, Placebo and Positive Controlled ,Parallel Group ,Phase II Study to Access the Efficacy and Safety of SP2086 Treated Type 2 Diabetes Patients

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: 50 mg SP2086
* Drug: 100 mg SP2086
* Drug: 200 mg SP2086
* Drug: 100 mg Sitagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Tablets(n=4),once daily for 84 days<br>|
| Experimental: 50 mg SP2086<br> | Drug: 50 mg SP2086<br>* Tablets(n=1),50mg strength+tablets(n=3) 0 mg once daily for 84 days<br>|
| Experimental: 100 mg SP2086<br> | Drug: 100 mg SP2086<br>* Tablets(n=1),100 mg strength+tablets(n=3) once 0 mg daily for 84 days<br>|
| Experimental: 200 mg SP2086<br> | Drug: 200 mg SP2086<br>* Tablets(n=2),100 mg strength+tablets(n=2) 0mg once daily for 84 days<br>|
| Active Comparator: 100 mg Sitagliptin<br> | Drug: 100 mg Sitagliptin<br>* Tablets(n=1),100 mg strength+tablets(n=3),0 mg strength once daily for 84 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change from baseline in HbA1c at 12 week |  | baseline, week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels |  | week 12 | 
| 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 | 
| Change from baseline in Homeostasis model assessment-beta(HOMA-β) at week 4,week12 |  | baseline, week 4,12week | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sp2086, Phase II, monotherapy