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Efficacy and Safety Study of SP2086 in Combination With Metformin in Patients With Type 2 Diabetes

NCT01969318 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2013-10-25

No results posted yet for this study

Summary

SP2086 is a new dipeptidyl peptidase(DPP)-4 inhibitor. This study aims to evaluate the efficacy and safety of SP2086 in combination therapy with Metformin in patients with Type 2 Diabetes in Metformin monotherapy Who have Inadequate Glycemic Control

Conditions

Interventions

DRUG

Placebo /Metformin

Patients are administered oral tablets of placebo once daily and metformin 500 mg t.i.d for 2 weeks at run-in period.After randomized,patients will be administered the drugs too

DRUG

SP2086(50 mg q.d.)/Metformin

patients are administered oral placebo once daily and metformin 500 mg t.i.d for 2 weeks at the run-in period .After randomized ,patients will be administered SP2086 50 mg q.d. and 500 mg t.i.d for 12 weeks

DRUG

SP2086 (100 mg q.d.)/Metformin

patients are administered oral placebo once daily and metformin 500 mg t.i.d for 2 weeks at the run-in period .After randomized ,patients will be administered SP2086 100 mg q.d. and 500 mg t.i.d for 12 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
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-08-31
Completion
2012-11-30

Countries

  • China

Study Locations

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Entities

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 NCT01969318 on ClinicalTrials.gov