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

NCT ID: NCT05782192

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 458 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-13
• Study Completion Date: 2022-03-25

Brief Summary

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

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SAL067

SAL067 12mg once daily

Group Type: EXPERIMENTAL

SAL067

Intervention Type: DRUG

SAL067 6mg(2 tablet) and placebo 25mg (1 tablet)

Alogliptin

Alogliptin 25mg once daily

Group Type: ACTIVE_COMPARATOR

Alogliptin

Intervention Type: DRUG

Alogliptin 25mg(1 tablet) and placebo 6mg (2 tablet)

placebo

placebo once daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo 6mg (2 tablet) and placebo 25mg (1 tablet)

Interventions

SAL067

SAL067 6mg(2 tablet) and placebo 25mg (1 tablet)

Intervention Type: DRUG

Alogliptin

Alogliptin 25mg(1 tablet) and placebo 6mg (2 tablet)

Intervention Type: DRUG

Placebo

placebo 6mg (2 tablet) and placebo 25mg (1 tablet)

Intervention Type: DRUG

Other Intervention Names

SAL067 Group; Alogliptin Group; Placebo Group

Eligibility 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. 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Salubris Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li Yan, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Locations

1. Sun Yat-sen Memorial Hospital, Sun Yat-sen University,

Guangzhou, Guangdong, China

Countries

China

References

Xu M, Sun K, Xu W, Wang C, Yan D, Li S, Cong L, Pi Y, Song W, Sun Q, Xiao R, Peng W, Wang J, Peng H, Zhang Y, Duan P, Zhang M, Liu J, Huang Q, Li X, Bao Y, Zeng T, Wang K, Qin L, Wu C, Deng C, Huang C, Yan S, Zhang W, Li M, Sun L, Wang Y, Li H, Wang G, Pang S, Zheng X, Wang H, Wang F, Su X, Ma Y, Zhang W, Li Z, Xie Z, Xu N, Ni L, Zhang L, Deng X, Pan T, Dong Q, Wu X, Shen X, Zhang X, Zou Q, Jiang C, Xi J, Ma J, Sun J, Yan L. Fotagliptin monotherapy with alogliptin as an active comparator in patients with uncontrolled type 2 diabetes mellitus: a randomized, multicenter, double-blind, placebo-controlled, phase 3 trial. BMC Med. 2023 Oct 9;21(1):388. doi: 10.1186/s12916-023-03089-x.

Reference Type: DERIVED

PMID: 37814306 (View on PubMed)

Other Identifiers

CTR20192469

Identifier Type: OTHER

Identifier Source: secondary_id

ChiCTR2000034343

Identifier Type: OTHER

Identifier Source: secondary_id

SAL067-C-009

Identifier Type: -

Identifier Source: org_study_id