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

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country450 target enrollmentDecember 2012

ConditionsType 2 Diabetes

InterventionsPlacebo SP2086 50 mg b.i.d.SP2086 100 mg q.d.

DrugsPlacebo SP2086 50 mg b.i.d.SP2086 100 mg q.d.

Overview

Phase: Phase 3
Intervention: Placebo
Conditions: Type 2 Diabetes
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 450
Locations: 1
Primary Endpoint: Change From Baseline in HbA1c (Hemoglobin A1C) at Week24
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

December 2012

End Date

January 2015

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Placebo

Intervention: Placebo

SP2086 50 mg b.i.d

Intervention: SP2086 50 mg b.i.d.

SP2086 100 mg q.d.

Intervention: SP2086 100 mg q.d.

Outcomes

Primary Outcomes

Change From Baseline in HbA1c (Hemoglobin A1C) at Week24

Time Frame: baseline, week 24

A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent

Secondary Outcomes

Change From Baseline in fasting plasma glucose (FPG) at Week 24(Weeks 0-24)
Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24(Weeks 0-24)
Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels(week24)
Change From Baseline in A1C at Week 52(week 52)
Change From Baseline in Body Weight at Week 4,8,12、24、38、52(Week 4、8、12、24、38、52)
Change From Baseline in FPG at Week 52(week 52)
Change From Baseline in lipid at Week 4、8、12、24、38、52(Week 4、8、12、24、38、52)