SAL067 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

Study Overview
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Brief Summary
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This is the first phase 3 randomized, double-blind, placebo/active-controlled clinical study to evaluate the efficacy and long-term safety of SAL067 in treatment-naive T2DM patients uncontrolled with diet and exercise intervention, comprising 24 weeks of double-blind treatment period followed by an open-label treatment period, making up a total of 52 weeks.

Detailed Description
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All eligible subjects would enter the 24 weeks of double-blind treatment period and were randomized into the SAL067 group (12 mg once daily) or alogliptin group (25 mg once daily) or placebo group at a 2:1:1 ratio. After 24 weeks of double-blind treatment, subjects would enter the extended open-label treatment period. Subjects in the placebo group were to be switched to SAL067 (12 mg once daily) treatment, while patients in the SAL067 and alogliptin groups continued the same treatment until the end of the whole 52 weeks.

Official Title
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A Multi-center, Randomized, Double-blind, Placebo/Positive Parallel Phase III Clinical Trial to Evaluate the Efficacy and Safety of SAL067 in Type 2 Diabetes Patients Who Cannot Effectively Control Blood Glucose Through Diet and Exercise

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: SAL067
* Drug: Alogliptin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes patients who meet the diagnostic criteria for diabetes issued by the World Health Organization (WHO) in 1999; Men or women aged 18 to 75 years old at the day of signing the informed consent; Body mass index: BMI 19kg/m2 to 35kg/m2, [BMI=weight (kg)/height 2 (m2)]; 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); Screening period and random time fasting blood glucose <=13.9mmol/L; Exclusion Criteria: Drug compliance during the introduction period <80% or >120%; Use other hypoglycemic drugs other than test drugs during the introduction period; The patient may have any contraindications, allergies or hypersensitivity to fuglitagliptin (including study drug and placebo) or its excipients, DPP4 drugs, metformin; 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, lactic acidosis 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; 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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAL067<br>SAL067 12mg once daily | Drug: SAL067<br>* SAL067 6mg(2 tablet) and placebo 25mg (1 tablet)<br>* Other names: SAL067 Group;|
| Active Comparator: Alogliptin<br>Alogliptin 25mg once daily | Drug: Alogliptin<br>* Alogliptin 25mg(1 tablet) and placebo 6mg (2 tablet)<br>* Other names: Alogliptin Group;|
| Placebo Comparator: placebo<br>placebo once daily | Drug: Placebo<br>* placebo 6mg (2 tablet) and placebo 25mg (1 tablet)<br>* Other names: Placebo Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c change from baseline at week 24 | Change From Baseline in Hemoglobin A1c (HbA1c) at week 24 | Baseline and week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c change from baseline at week 4、week 12、week 40 and week 52 | Change From Baseline in Hemoglobin A1c (HbA1c) at week 4、week 12、week 40 and week 52 | Baseline 、week 4、week 12、week 40 and week 52 | 
| FPG change from baseline at week 4、week 8、week 12、week16、week24、week 40 and week 52 |  | Baseline、week 4、week 8、week 12、week16、week24、week 40 and week 52 | 
| Percentage of patients with HbA1c <7.0% and HbA1c <6.5% at week 24 and week 52 |  | Baseline 、week 24 and week 52 | 
| Percentage of patients required use of rescue therapy at week 24 and week 52 |  | Baseline 、week 24 and week 52 | 
| Fasting c-peptide change from baseline at week 24 and week 52 |  | Baseline 、week 24 and week 52 | 
| Insulin sensitivity change (calculated by HOMA-IS) from baseline at week 24 and week 52 |  | Baseline 、week 24 and week 52 | 
| Pancreatic β-cell function change (calculated by HOMA-β ) from baseline at week 24 and week 52 |  | Baseline 、week 24 and week 52 |