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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
120
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
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
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
Chinese PLA General Hospital
Beijing, China
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 12
Time frame: baseline, week 12
Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels
Time frame: week 12
Change From Baseline in Fasting Plasma Glucose at Week 4, 8 and 12
Time frame: Baseline, Week 4, 8, 12
Post-meal total and incremental glucose,insulin and C-peptide area under the curve at week 12
Time frame: baseline, week 12
Change from baseline in Homeostasis model assessment-beta(HOMA-β) at week12
Time frame: baseline, week 12
Change From Baseline in lipid at Week 12
Time frame: baseline, week12
Change From Baseline in Body Weight at Week 4,8,12
Time frame: baseline, Week 4, 8,12
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