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A Phase III Study of SP2086 in Combination With Metformin in Patients With Type 2 Diabetes

NCT01970046 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

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 in combination therapy with Metformin in patients with Type 2 Diabetes Mellitus in Metformin monotherapy Who Have Inadequate Glycemic Control

Conditions

Interventions

DRUG

Placebo/Metformin

* Run in period ：placebo and metformin 500 mg t.i.d for 6 weeks * Phase A : Placebo and metformin 500 mg t.i.d for 24 weeks * Phase B : SP2086 50 mg b.i.d and metformin 500 mg t.i.d for 28 weeks

DRUG

SP2086 50 mg b.i.d/Metformin

* Run-in period: placebo and Metformin 500 mg t.i.d for 6weeks * Phase A:SP2086 50 mg b.i.d and Metformin 500 mg t.i.d for 24 weeks * Phase B:SP2086 50 mg b.i.d and Metformin 500 mg t.i.d for 28 weeks

DRUG

SP2086 50 mg q.d./Metformin

* Run-in period: placebo and Metformin 500 mg t.i.d for 6 weeks * Phase A:SP2086 50 mg q.d and Metformin 500 mg t.i.d for 24 weeks * Phase B:SP2086 50 mg q.d and Metformin 500 mg t.i.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
2013-04-30
Primary Completion
2014-01-31
Completion
2015-01-31

Countries

  • China

Study Locations

More Related Trials

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 NCT01970046 on ClinicalTrials.gov