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

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

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 Overview

• Status: Unknown
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Placebo; Drug: SP2086 50 mg b.i.d.; Drug: SP2086 100 mg q.d.

• Study Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	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
EXPERIMENTAL: SP2086 50 mg b.i.d	Drug: 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
EXPERIMENTAL: SP2086 100 mg q.d.	Drug: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ANTICIPATED): January 1, 2014
• Study Completion (ANTICIPATED): January 1, 2015

Study Registration Dates

• First Submitted: October 18, 2013
• First Submitted That Met QC Criteria: October 22, 2013
• First Posted (ESTIMATE): October 25, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): October 25, 2013
• Last Update Submitted That Met QC Criteria: October 22, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Phase III; Monotherapy; SP2086
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: HR-SP2086-301