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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: SAL067; Drug: Alogliptin; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 458
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • 1. Sun Yat-sen Memorial Hospital, Sun Yat-sen University,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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. 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);
5. 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, 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;

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;

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAL067; SAL067 12mg once daily	Drug: SAL067; SAL067 6mg(2 tablet) and placebo 25mg (1 tablet); Other Names: SAL067 Group
Active Comparator: Alogliptin; Alogliptin 25mg once daily	Drug: Alogliptin; Alogliptin 25mg(1 tablet) and placebo 6mg (2 tablet); Other Names: Alogliptin Group
Placebo Comparator: placebo; placebo once daily	Drug: Placebo; placebo 6mg (2 tablet) and placebo 25mg (1 tablet); Other Names: Placebo Group

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.
• Investigators: Principal Investigator: Li Yan, Ph.D, Sun Yat-sen Memorial Hospital,Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2019
• Primary Completion (Actual): March 25, 2022
• Study Completion (Actual): March 25, 2022

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Alogliptin
• Other Study ID Numbers: SAL067-C-009; CTR20192469 (Other Identifier: NMPA); ChiCTR2000034343 (Other Identifier: Chinese Clinical Trial Registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No