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

NCT05801627 | Completed Phase 3

• 3 other identifiers: SAL067-C-008CTR20200061ChiCTR2000033616
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c change from baseline at week 24

  Change From Baseline in Hemoglobin A1c (HbA1c) at week 24

  Baseline and week 24

Secondary Outcomes (7)

• HbA1c change from baseline 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, week 16, week 24, week 40 and week 52

  Baseline, week 4, week 8, week 12, week 24, 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

Study Arms (2)

SAL067

EXPERIMENTAL

SAL067 12mg once daily

Drug: SAL067

Placebo

PLACEBO COMPARATOR

placebo once daily

Drug: Placebo

Interventions

SAL067 DRUG

SAL067 6mg(2 tablet) and Metformin ≥1500mg

Also known as: SAL067 Group

SAL067

Placebo DRUG

Placebo (2 tablet) and Metformin ≥1500mg

Also known as: Placebo Group

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, \[BMI=weight (kg)/height 2 (m2)\];
• Subjects treated with metformin≥ 1500mg/day constantly for at least 8 consecutive weeks before screnning;
• 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.

You may not qualify if:

• 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, 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;
• 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.

Sponsors & Collaborators

• Shenzhen Salubris Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Peking University Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Xiaohui Guo, Ph.D

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: April 6, 2023
• Study Start: May 6, 2020
• Primary Completion: May 24, 2022
• Study Completion: May 24, 2022
• Last Updated: April 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)