Efficacy and Safety Study of SHR117887 in Combination With Metformin in Patients With Type 2 Diabetes

Hengrui Medicine

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: Placebo; Drug: SHR117887

Study type: Interventional

Funder types: Industry

Identifiers

NCT01984489

SHR117887-201

Details and patient eligibility

About

SHR117887 is a new dipeptidyl peptidase(DPP)-4 inhibitor. This study aims to evaluate the efficacy and safety of SHR117887 in combination therapy with Metformin in patients with Type 2 Diabetes in Metformin monotherapy Who have Inadequate Glycemic Control

Enrollment: 120 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with type 2 diabetes mellitus
• Patients have been treated with metformin for at least 8 weeks and be on a stable dose of at least 1500mg daily prior to the screening visit
• HbA1C：≥7.5% and ≤11.0% at screeing visit and at the end of run-in period
• Age:≥20 and ≤70 years
• BMI(body mass index):≥20 and ≤35 kg/m2

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

120 participants in 3 patient groups, including a placebo group

Placebo/Metformin

Placebo Comparator group

Description:

patients are administered oral tablets of placebo once daily and 500mg TID for 4 weeks at the run-in period. After randomized ,patients administer the drugs too.

Treatment:

Drug: Placebo

SHR117887 (50mg q.d)/Metformin

Experimental group

Description:

patients are administered oral placebo once daily and metformin 500mg TID for 4 weeks at the run-in period.After randomised,patients adminitered SHR117887 50mg QD and metformin 500mg TID for 12 weeks.

Treatment:

Drug: SHR117887

SHR117887 (100mg q.d)/Metformin

Experimental group

Description:

patients are administered oral placebo once daily and metformin 500mg TID for 4 weeks at the run-in period.After randomised,patients adminitered SHR117887 100mg QD and metformin 500mg TID for 12 weeks.

Treatment:

Drug: SHR117887