The purpose of this study is to assess the efficacy of HSK7653 (as an add-on to metformin) compared with linagliptin after 24 weeks, and the safety (up to 52 weeks) of HSK7653 in Chinese patients with Type 2 Diabetes who have inadequate glycemic control on diet/exercise therapy and metformin agent monotherapy.
The treatment period is composed of a 24-week double-blind period (week 1-24) and a 28-week open-label period (week 25-52). During the double-blind period, participants will receive 10 mg or 25 mg dose of HSK7653, or linagliptin, and with matching placebo respectively. During the open-label period, all participants will receive 25 mg dose of HSK7653. All participants will receive a stable dose of metformin therapy in both the double-blind period and the open-label period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
465
HSK7653 5 mg (2 tablets) and placebo 25 mg (1 tablet) Q2W, placebo of linagliptin 5 mg QD, oral, week 1 to week 24; HSK7653 25 mg Q2W, oral, week 25 to week 52.
HSK7653 25 mg (1 tablet) and placebo 5 mg (2 tablets) Q2W, placebo of linagliptin 5 mg QD, oral, week 1 to week 24; HSK7653 25 mg (1 tablet) Q2W, oral, week 25 to week 52.
Linagliptin 5 mg QD, placebo of HSK7653 25 mg (1 tablet) and 5 mg (2 tablets) Q2W, oral, week 1 to week 24; HSK7653 25 mg Q2W, oral, week 25 to week 52.
Peking University People's Hospital
Beijing, Beijing Municipality, China
Inner Mongolia Baogang Hospital
Baotou, Inner Mongolia, China
HbA1c Change From Baseline at Week 24
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
Time frame: Baseline and week 24
Incidence of Treatment-Emergent Adverse Events
The incidence of Treatment-Emergent Adverse Events over time (at week 24 and week 52)
Time frame: Baseline, week 24 and week 52
Percentage of Patients With HbA1c <7.0%
Time frame: Baseline, week 24 and week 52
Percentage of Patients With HbA1c <6.5%
Time frame: Baseline, week 24 and week 52
FPG Change From Baseline at Week 24 and Week 52
Time frame: Baseline , week 24 and week 52
2h-PPG Change From Baseline at Week 24 and Week 52
Time frame: Baseline, week 24 and week 52
Weight Change From Baseline at Week 24 and Week 52
Time frame: Baseline, week 24 and week 52
Fasting C-peptide Change From Baseline at Week 24 and Week 52
Time frame: Baseline, week 24 and week 52
Insulin Sensitivity Change (Calculated by HOMA-IS) From Baseline at Week 24 and Week 52
Time frame: Baseline, week 24 and week 52
Pancreatic β-cell function Change (Calculated by HOMA-β) From Baseline at Week 24 and Week 52
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Time frame: Baseline, week 24 and week 52
Percentage of Patients Required Use of Rescue Therapy or Dropout due to Hyperglycemia and Week 52
Time frame: Baseline, week 24 and week 52