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

NCT01970033 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2013-10-25

No results posted yet for this study

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

Conditions

Interventions

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

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

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

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Changyu Pan, M.D. · Chinese PLA General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-01-31
Completion
2015-01-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01970033 on ClinicalTrials.gov