Efficacy and Safety of SP2086 as Monotherapy in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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SP2086 is a new dipeptidy1 peptidase(DPP)-4 inhibitors. This study aims to evaluate the efficacy and safety of SP2086 as monotherapy in patients with Type 2 Diabetes Mellitus in Metformin monotherapy Who Have Inadequate Glycemic Control treated with diet and exercise for 3 months

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Placebo
* Drug: SP2086 50 mg b.i.d.
* Drug: SP2086 100 mg q.d.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with type 2 diabetes mellitus Patients have treated with diet/exercise at least 3 months 7.5% ≤HbA1C ≤11.0% at screening,7.0% ≤HbA1C ≤10.5% after run-in 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
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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>* Run in period ：oral tablets of Placebo twice daily for 2 weeks Phase A : oral tablets of Placebo twice daily for 24 weeks Phase B : SP2086 50 mg b.i.d or SP2086 100 mg q.d. for 28 weeks<br>|
| Experimental: SP2086 50 mg b.i.d<br> | Drug: SP2086 50 mg b.i.d.<br>* Run-in period: placebo twice daily for 2 weeks Phase A:SP2086 50 mg b.i.d for 24 weeks Phase B:SP2086 50 mg b.i.d for 28 weeks<br>|
| Experimental: SP2086 100 mg q.d.<br> | Drug: SP2086 100 mg q.d.<br>* Run-in period:placebo twice daily for 2 weeks Phase A: SP2086 100 mg q.d. for 24 weeks Phase B: SP2086 100 mg q.d. for 28 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HbA1c (Hemoglobin A1C) at Week24 | A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent | baseline, week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in fasting plasma glucose (FPG) at Week 24 | Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG | Weeks 0-24 | 
| Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24 | Change from baseline at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG | Weeks 0-24 | 
| Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels |  | week24 | 
| Change From Baseline in A1C at Week 52 | A1C is measured as a percent. Thus, this change from baseline reflects the Week 52 A1C percent minus the Week 0 A1C percent | week 52 | 
| Change From Baseline in FPG at Week 52 | Change from baseline at Week 52 is defined as Week 104 FPG minus Week 0 FPG | week 52 | 
| Change From Baseline in lipid at Week 4、8、12、24、38、52 |  | Week 4、8、12、24、38、52 | 
| Change From Baseline in Body Weight at Week 4,8,12、24、38、52 |  | Week 4、8、12、24、38、52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SP2086, Phase III, Monotherapy