Overview

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.