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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01970033
• Other study ID #: HR-SP2086-301
• Status: Recruiting
• Phase: Phase 3
• First received: October 18, 2013
• Last updated: October 22, 2013
• Start date: December 2012
• Est. completion date: January 2015

Study information

• Verified date: October 2013
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Changyu Pan, M.D.
• Phone: 86 10 66887329
• Email: panchy301[@]aliyun.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: January 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Placebo
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
• SP2086 50 mg b.i.d.
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
• SP2086 100 mg q.d.
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

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels		week24	No
Secondary	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	No
Secondary	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	No
Secondary	Change From Baseline in lipid at Week 4?8?12?24?38?52		Week 4?8?12?24?38?52	No
Secondary	Change From Baseline in Body Weight at Week 4,8,12?24?38?52		Week 4?8?12?24?38?52	No