The Efficacy and Safety of Different Doses of SY-009 in Patients With Type 2 Diabetes Mellitus

NCT05426018 | Unknown Phase 2

• 1 other identifier: SY009003
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 7

Brief Summary

SY-009 is a novel compound that inhibits sodium glucose cotransporter-1 (SGLT-1). The preclinical and phase 1 clinical trial data support to carry out phase II clinical trial in diabetes subjects.

Conditions

Type 2 Diabetes

Keywords

Sodium glucose cotransporter-1 (SGLT-1) inhibitor

Outcome Measures

Primary Outcomes (1)

• Changes of HbA1c compared with baseline at 12 weeks

  Changes of HbA1c in each dose group compared with baseline at 12 weeks of treatment

  12 weeks

Secondary Outcomes (16)

• Changes of HbA1c compared with baseline at 8 weeks

  8 weeks

• Changes of maximum blood glucose increase (0-180min) after breakfast compared with baseline at 12 weeks

  12 weeks

• Proportion of subjects with HbA1c ≤ 7%

  8 weeks，12 weeks

• Proportion of subjects with HbA1c ≤ 6.5%

  8 weeks，12 weeks

• Changes of blood glucose at 2h after breakfast compared with baseline

  12 weeks

Study Arms (4)

SY-009 -1

EXPERIMENTAL

0.5mg tid

Drug: SY-009 capsules

SY-009-2

EXPERIMENTAL

1.0mg tid

Drug: SY-009 capsules

SY-009-3

EXPERIMENTAL

1.5mg tid

Drug: SY-009 capsules

Placebo

PLACEBO COMPARATOR

tid

Drug: SY-009 capsules

Interventions

SY-009 capsules DRUG

3 capsules each time (3 test drugs), 3 times a day (oral administration before breakfast, lunch, dinner or with meals)

Placebo; SY-009 -1; SY-009-2; SY-009-3

Eligibility Criteria

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

You may qualify if:

• Subjects were ≥ 18 years old and ≤ 75 years old at the first screening (visit 1);
• At the first screening (visit 1) and the baseline period (visit 3), male weight ≥ 50kg, female weight ≥ 45kg, and body mass index (BMI) between 18.0 and 35.0 kg/m2 (including the critical value);
• At the first screening (visit 1), the subjects had been diagnosed with type 2 diabetes for at least 3 months according to the WHO diagnostic criteria and classification in 1999;
• The subjects had been receiving diet control and exercise therapy for 3 months before the first screening (visit 1), and had not received systematic treatment for diabetes during this period (the cumulative use of hypoglycemic drugs in recent 3 months was not more than 2 weeks, and no hypoglycemic drugs were used in recent 1 month);
• The subjects' HbA1c at the first screening (visit 1) was between 7.5% and 10.5% (including the critical value); During the baseline period (visit 3), HbA1c was between 7.0% and 10.5% (including the critical value);
• Subjects' fasting blood glucose ≤ 13.3mmol/l in the baseline period (visit 3);
• Before the trial, the nature, significance, possible benefits, possible inconvenience, potential risks and discomfort of the trial have been understood in detail, and they have volunteered to participate in the clinical trial. They can communicate well with researchers, comply with the requirements of the whole trial, and have signed a written informed consent.

You may not qualify if:

• Known allergic to the test drug (including the excipients of the test drug) or its analogues, or allergic constitution (such as allergic to two or more drugs, food and pollen), or having taken SGLT-1 or sglt-2 inhibitors in the past 1 year;
• Received long-term (\>2 weeks) systemic glucocorticoid therapy (excluding topical, ophthalmic or inhaled preparations) within 3 months before screening;
• Diagnosed as type 1 diabetes, or gestational diabetes, or other special types of diabetes;
• There is sufficient evidence of active diabetes proliferative retinopathy;
• History of severe hypoglycemia (such as consciousness disorder and coma caused by hypoglycemia), or history of serious unconscious hypoglycemia;
• History of acute metabolic complications of diabetes within 6 months before screening (diabetes ketoacidosis, hypertonic non ketoacidosis coma, diabetes lactic acidosis);
• Serious trauma, serious infection or operation that may affect blood glucose control occurred within 1 month before screening;
• There are obvious blood system diseases (such as aplastic anemia, myelodysplastic syndrome), or any disease that causes hemolysis or red blood cell instability (such as malaria), or hemoglobinopathy that may affect the determination of HbA1c level (such as sickle cell disease);
• Have obvious autonomic neuropathy, such as urinary retention, postural hypotension, diabetes diarrhea or gastroparesis；
• Habitual diarrhea, irritable bowel syndrome, clinically significant abnormal gastric emptying (such as gastric outlet obstruction), severe chronic gastrointestinal diseases (such as active ulcer within 6 months) or gastrointestinal surgery within 3 months before screening;
• History of organ transplantation (excluding corneal transplantation), or other acquired or congenital immune system diseases, or clinically significant peripheral vascular diseases;
• History of heart failure (NYHA grade III and IV), or history of acute myocardial infarction or unstable angina pectoris within 6 months before screening; Or have a history of coronary angioplasty, coronary stent implantation or coronary artery bypass surgery within 6 months before screening or have a recent cardiac surgery plan;
• In the screening period, when no pacemaker was installed, grade II or III atrioventricular block or qtcb interval was prolonged \>500 MS in 12 lead ECG;
• Patients with abnormal thyroid function (such as thiourea and thyroid hormone drugs) whose treatment dose was not stable within the first 6 months were screened; Hypothyroidism with poor control or history of hypothyroidism;
• Unstable weight (weight change more than 5kg) within 2 months before screening, or used drugs with weight control effect or performed surgery that can lead to unstable weight, or is currently in the weight loss plan and is not in the maintenance stage;

Sponsors & Collaborators

• Suzhou Yabao Pharmaceutical R&D Co., Ltd.: lead

Study Sites (7)

The Second Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Location

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

The first hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Changsha Central Hospital

Changsha, Hunan, China

Location

Chengdu Fifth People's Hospital

Chengdu, Sichan, China

Location

Affiliated Hospital of Hangzhou Normal University

Hangzhou, Zhejiang, 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

Central Study Contacts

Dalong Zhu, DR

CONTACT

13805150781; zhudalong@nju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: July 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: October 1, 2023
• Last Updated: June 21, 2022

Record last verified: 2022-05

Locations

CN (7)