The Efficacy and Safety of Different Doses of SY-004 in Patients With Type 2 Diabetes Mellitus

NCT04217291 | Completed Phase 2

• 1 other identifier: SY004003
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study in patients with type 2 diabetes mellitus (T2DM).

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Changes in Glycosylated Hemoglobin A1c (HbA1c)

  Changes in Glycosylated Hemoglobin A1c relative to baseline at 16 weeks compared to placebo.

  16 weeks

Secondary Outcomes (8)

• the proportion of subjects whose Glycosylated Hemoglobin A1c (HbA1c) was less than 7%.

  16 weeks

• The proportion of subjects with Glycosylated Hemoglobin A1c (HbA1c) < 6.5%

  16 weeks

• Changes in Glycosylated Hemoglobin A1c (HbA1c)

  8 weeks

• the proportion of subjects whose Glycosylated Hemoglobin A1c (HbA1c) was less than 7%

  8 weeks

• The proportion of subjects with Glycosylated Hemoglobin A1c (HbA1c) < 6.5%

  8 weeks

Study Arms (4)

SY-004-1

EXPERIMENTAL

a dose of 80mg/day taken orally for two weeks, and a dose of 80mg/day for 14 weeks from the third week

Drug: SY-004

SY-004-2

EXPERIMENTAL

a dose of 80mg/day taken orally for two weeks, and a dose of 160mg/day for 14 weeks from the third week.

Drug: SY-004

SY-004-3

EXPERIMENTAL

a dose of 80mg/day orally in the first week, a dose of 160mg/day in the second week and a dose of 240mg/day for 14 weeks from the third week.

Drug: SY-004

placebo

PLACEBO COMPARATOR

a dose of SY-004 matching placebo taken orally

Other: SY-004 matching placebo

Interventions

SY-004 DRUG

Take orally once a day

SY-004-1; SY-004-2; SY-004-3

SY-004 matching placebo OTHER

Take orally once a day

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:

• Gender is not limited.
• Age at screening: ≥ 18 years old, ≥ 75 years old.
• According to WHO diagnostic criteria and classification in 1999, type 2 diabetes was diagnosed, with a course of at least 3 months.
• During screening and before randomization, 18kg / m2 ≤ BMI ≤ 35kg / m2.
• At the time of screening, they had been treated with diet or exercise for at least 3 months.
• No antidiabetic drugs were used at the time of screening, or the antidiabetic drugs were used irregularly within 3 months before screening (the cumulative use of antidiabetic drugs in the past 3 months was no more than 2 weeks and no antidiabetic drugs were used in the past 1 month).
• During screening, 7% of the samples detected by local laboratory were ≤ HbA1c ≤ 11%.
• Before randomization, the central laboratory tested 7% ≤ HbA1c ≤ 11%.
• Fasting blood glucose (FBG) of 7-13.3 mmol / L (including boundary value) was measured in the central laboratory before randomization.
• The subjects must have informed consent before the study, and signed the written informed consent voluntarily.
• The subjects were willing and able to use the home blood glucose meter for self blood glucose monitoring.
• The subjects were able to communicate well with the researchers and complete the study according to the protocol.

You may not qualify if:

• Staff members and their immediate family members of the research project. Lineal relatives refer to persons with consanguineous or legal relationships, including spouses, parents, children, brothers and sisters.
• Any of the following drugs or treatments were used prior to screening:
• In the past six months, insulin therapy has been used for more than one month, or insulin therapy is needed at present.
• Long acting GLP-1 has been used in the past 6 months.
• Glucokinase activator (GKA) was used in the past 6 months.
• In the past 6 months, I have received weight-loss drugs or any weight-loss treatment (such as surgery, excessive diet and exercise therapy) that leads to weight instability.
• Participated in clinical trials of any drug or medical device in the past 3 months.
• Other drugs that may affect blood glucose metabolism have been used in the past 8 weeks, including growth hormone treatment, and long-term or repeated intermittent systemic glucocorticoids (intravenous, oral or intra-articular administration for more than 2 weeks or repeated courses, except inhalation or local external use), etc.
• Strong CYP3A inducers or strong CYP3A inhibitors have been used in the past two weeks or are planned to be used in the near future (refer to appendix 12.5.1).
• Drugs that are likely to cause torsade de pointes have been used in the past two weeks or planned in the near future (refer to appendix 12.5.2).
• Prior to screening, there was a history or evidence of any of the following diseases:
• Type 1 diabetes, special type diabetes and secondary diabetes.
• Significant clinical cardiovascular events have occurred in the past 6 months (refer to appendix 12.3).
• Patients with clinically significant peripheral vascular lesions, such as ischemic ulcer or gangrene, diabetic foot ulcer and infection.
• There is sufficient evidence for the presence of active diabetic proliferative retinopathy or maculopathy that is unstable or in need of treatment.

Sponsors & Collaborators

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

Study Sites (1)

PLA General Hospital

Beijing, Beijing Municipality, 100853, 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

• Mu

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

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: December 30, 2019
• First Posted: January 3, 2020
• Study Start: December 10, 2019
• Primary Completion: July 9, 2021
• Study Completion: July 9, 2021
• Last Updated: May 18, 2022

Record last verified: 2021-05

Locations

CN (1)