NCT01970033UnknownPhase 3
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 enrollmentStarted: December 2012Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 450
- Locations
- 1
- Primary Endpoint
- Change From Baseline in HbA1c (Hemoglobin A1C) at Week24
Study 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
SP2086 50 mg b.i.d
Experimental
Intervention: SP2086 50 mg b.i.d. (Drug)
SP2086 100 mg q.d.
Experimental
Intervention: SP2086 100 mg q.d. (Drug)
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)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Phase 3
A Phase III Study of SP2086 in Combination With Metformin in Patients With Type 2 DiabetesType 2 DiabetesNCT01970046Jiangsu HengRui Medicine Co., Ltd.360
Completed
Phase 2
Efficacy and Safety Study of SP2086 in Combination With Metformin in Patients With Type 2 DiabetesType 2 DiabetesNCT01969318Jiangsu HengRui Medicine Co., Ltd.120
Completed
Phase 2
A Study of the Effectiveness and Safety of SP2086 to Treat Type 2 DiabetesType 2 DiabetesNCT01969357Jiangsu HengRui Medicine Co., Ltd.200
Completed
Phase 2
Efficacy and Safety Study of SHR117887 in Combination With Metformin in Patients With Type 2 DiabetesType 2 DiabetesNCT01984489Jiangsu HengRui Medicine Co., Ltd.120
Completed
Phase 3
DPP4inhibitors in Type 1 DiabetesHypoglycaemiaType 1 DiabetesNCT01922817University of Dundee28