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

Primary Purpose

Type 2 Diabetes

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Placebo

SP2086 50 mg b.i.d.

SP2086 100 mg q.d.

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring SP2086, Phase III, Monotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

SP2086 50 mg b.i.d

SP2086 100 mg q.d.

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels

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

Change From Baseline in FPG at 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

Change From Baseline in Body Weight at Week 4,8,12、24、38、52

Full Information

NCT ID

NCT01970033

First Posted

October 18, 2013

Last Updated

October 22, 2013

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01970033

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Unknown status

Study Start Date

December 2012 (undefined)

Primary Completion Date

January 2014 (Anticipated)

Study Completion Date

January 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

Keywords

SP2086, Phase III, Monotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

SP2086 50 mg b.i.d

Arm Type

Experimental

Arm Title

SP2086 100 mg q.d.

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

SP2086 50 mg b.i.d.

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

SP2086 100 mg q.d.

Intervention Description

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

Primary Outcome Measure Information:

Title

Change From Baseline in HbA1c (Hemoglobin A1C) at Week24

Description

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

Time Frame

baseline, week 24

Secondary Outcome Measure Information:

Title

Change From Baseline in fasting plasma glucose (FPG) at Week 24

Description

Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG

Time Frame

Weeks 0-24

Title

Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24

Description

Change from baseline at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG

Time Frame

Weeks 0-24

Title

Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels

Time Frame

week24

Title

Change From Baseline in A1C at Week 52

Description

A1C is measured as a percent. Thus, this change from baseline reflects the Week 52 A1C percent minus the Week 0 A1C percent

Time Frame

week 52

Title

Change From Baseline in FPG at Week 52

Description

Change from baseline at Week 52 is defined as Week 104 FPG minus Week 0 FPG

Time Frame

week 52

Title

Change From Baseline in lipid at Week 4、8、12、24、38、52

Time Frame

Week 4、8、12、24、38、52

Title

Change From Baseline in Body Weight at Week 4,8,12、24、38、52

Time Frame

Week 4、8、12、24、38、52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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 Patient has history of malignancy Patient has history of alcohol or drug abuse

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Changyu Pan, M.D.

Phone

86 10 66887329

panchy301@aliyun.com

First Name & Middle Initial & Last Name or Official Title & Degree

Huaqiong Shen, P.H.D

Phone

86 21 68868570

Ext

827

shenhuaqiong@hrs.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Changyu Pan, M.D.

Organizational Affiliation

Chinese PLA General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chinese PLA General Hospital

City

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Changyu Pan, M.D.

panchy301@aliyun.com

First Name & Middle Initial & Last Name & Degree

Changyu Pan, M.D.

12. IPD Sharing Statement

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

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