SAL067 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled by Metformin

• Status: Completed
• Trial end date: 2022-05-24
• Target enrollment: 0
• Participant gender: All

Summary

This is the phase 3 randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and long-term safety of SAL067 in T2DM patients uncontrolled by metformin, comprising 24 weeks of double-blind treatment period followed by an open-label treatment period, making up a total of 52 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.

Criteria

Inclusion Criteria:

1. Type 2 diabetes patients who meet the diagnostic criteria for diabetes issued by the World Health Organization (WHO) in 1999;

2. Men or women aged 18 to 75 years old at the day of signing the informed consent;

3. Body mass index: BMI 19kg/m2 to 35kg/m2, [BMI=weight (kg)/height 2 (m2)];

4. Subjects treated with metformin≥ 1500mg/day constantly for at least 8 consecutive weeks before screnning;

5. Glycated hemoglobin (HbA1c): Screening period: HbA1c 7.5% to 10.5% (tested by the research center), when randomly enrolled: HbA1c 7.0% to 10.0% (central laboratory test) Measurement);

6. Screening period and random time fasting blood glucose <=13.9mmol/L.

Exclusion Criteria:

1. Drug compliance during the introduction period <80% or >120%;

2. Use other hypoglycemic drugs other than test drugs during the introduction period;

3. The patient may have any contraindications, allergies or hypersensitivity to fuglitagliptin (including study drug and placebo) or its excipients, DPP4 drugs, metformin;

4. Before screening, have any of the following endocrine-related medical history or evidence:

• Diabetes other than type 2 diabetes, such as type 1 diabetes, single-gene mutation diabetes, diabetes caused by pancreatic injury or secondary diabetes, such as diabetes caused by Cushing's syndrome or acromegaly;

• diabetic ketoacidosis, hyperglycemia and hyperosmolarity, lacticacidosis and other acute complications of diabetes within 6 months before screening;

• severe hypoglycemia episodes (such as sleepiness caused by hypoglycemia, unconsciousness, nonsense, and even coma), or a serious history of unconscious hypoglycemia;

5. Before screening, there is a history or evidence of any of the following diseases:

• Unstable angina, stroke or transient ischemic attack, myocardial infarction, coronary artery bypass graft or percutaneous coronary intervention (diagnostic angiography is allowed of);

• Decompensated heart failure before screening (New York Heart Association NYHA heart function grades III and IV, persistent and clinically significant arrhythmia;

• A history of acute and chronic pancreatitis, symptomatic gallbladder disease or history of pancreatic injury, etc. may lead to high risk factors for pancreatitis.