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

Phase 3

• Conditions: Type 2 Diabetes
• Interventions: Drug: Placebo; Drug: SP2086 100 mg q.d.; Drug: SP2086 50 mg b.i.d.

• Registration Number: NCT01970033
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Status Verified: 2013-10
• Study First Submitted: 2013-10-18
• Study First Submitted QC: 2013-10-22
• Last Update Submitted: 2013-10-22
• Study First Posted: 2013-10-25
• Last Update Posted: 2013-10-25
• Primary Completion: 2014-01
• Study Completion: 2015-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
SP2086 100 mg q.d.	SP2086 100 mg q.d.	-
SP2086 50 mg b.i.d	SP2086 50 mg b.i.d.	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c (Hemoglobin A1C) at Week24	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 Outcome Measures

Name	Time	Method
Change From Baseline in fasting plasma glucose (FPG) at Week 24	Weeks 0-24	Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG
Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24	Weeks 0-24	Change from baseline at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG
Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels	week24
Change From Baseline in A1C at Week 52	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
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 at Week 52 is defined as Week 104 FPG minus Week 0 FPG
Change From Baseline in lipid at Week 4、8、12、24、38、52	Week 4、8、12、24、38、52

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, China