A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Placebo in T2DM Patients

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Phase 3, Multi-center, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of JY09 in Patients With T2DM Inadequately Controlled by Diet and Exercise Alone

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06254014
• Other study ID #: DFBT-JY09-DM-301
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 1, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: February 2024
• Source: Beijing Dongfang Biotech Co., Ltd.
• Contact: Xuefeng Li, Master
• Phone: 13683259746
• Email: lixuefeng[@]east-bt.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to investigate the efficacy and safety of JY09 versus placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled by diet and exercise alone

Description:

This study was designed as a multicenter, randomized, double-blind, placebo-parallel controlled Phase III clinical study to evaluate the efficacy and safety of Exendin-4Fc fusion protein (JY09) injection in adult subjects with type 2 diabetes mellitus (T2DM) who have poor glycemic control after dietary exercise intervention only.

The proposed plan is to enroll 270 subjects with T2DM, using stratified block group randomization, with the stratification factor being baseline HbA1c (≤8.5% or >8.5%), and randomly assign them to the 1.2 mg JY09 injection group (n=90 subjects), the 2.4 mg JY09 injection group (n=90 subjects), and the placebo group (n=90 subjects) in a 1:1:1 ratio.

The trial was divided into 4 phases, i.e., a screening period of 2 weeks, a single-blind introduction period of 4 weeks, a treatment period of 54 weeks (26 weeks for the core treatment period and 28 weeks for the extended treatment period), and a safety follow-up period of 4 weeks. Total 64 weeks.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 270
• Est. completion date: December 30, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Male or female subjects =18 years of age and =75 years of age at the time of signing the informed consent form.

2. Those who met the diagnostic criteria for type 2 diabetes mellitus promulgated by World Health Organization(WHO) in 1999 and who had been diagnosed with T2DM for =12 weeks.

3. Those who received dietary and exercise interventions for =8 weeks prior to screening and who had not received any antidiabetic medications in the 8 weeks prior to screening.

4. HbA1c =7.5% and =11.0% at screening (local laboratory) and HbA1c =7.0% and =10.5% before randomization (V3) (central laboratory).

5. FPG 13.9 mmol/L at screening (local laboratory) and FPG 13.9 mmol/L before randomization (V3) (central laboratory).

6. Body mass index (BMI) =18.5 kg/m2 and =35.0 kg/m2 at screening and before randomization (V3).

7. Able to understand and willing to sign a written informed consent form (ICF) and comply with the study protocol.

Exclusion Criteria:

1. People diagnosed with type 1 diabetes or other types of diabetes.

2. Those who have used other hypoglycemic agents within 8 weeks prior to screening or prior to randomization (V3), or those who have used medications that may affect glucose metabolism, such as systemic glucocorticoids (except for inhalation or topical topical use), growth hormones, etc.

3. Acute complications of diabetes, such as diabetic ketoacidosis or hyperglycemic hyperosmolar state, within 6 months prior to screening or prior to randomization.

4. Severe chronic complications of diabetes mellitus (e.g., proliferative diabetic retinopathy, severe diabetic neuropathy, diabetic foot, etc.) within 6 months prior to screening, which are assessed by the investigator to be unsuitable for participation in this clinical study.

5. Persons who have had a severe trauma or serious infection within 1 month prior to screening or prior to randomization (V3) that may affect glycemic control, and persons who currently have a complicated or refractory urinary or genital tract infection.

6. Suffering from any condition at screening or prior to randomization (V3) that may cause hemolysis or red blood cell instability that would interfere with the measurement of HbA1c levels, such as hemolytic anemia.

7. Subjects who have abnormal thyroid function tests at Screening and require medication, or subjects who are being treated with thyroid-related medications whose thyroid function is still not well controlled at Screening.

8. Those with any of the following abnormalities on serologic testing at screening:

1)Positive human immunodeficiency virus antibodies or syphilis spirochete-specific antibodies; 2)Hepatitis C antibody positive; 3)Hepatitis B virus surface antigen (HBsAg) positive and hepatitis B viral load (HBV-DNA) above the lower limit of laboratory testing (HBV-DNA is added only if HBsAg is positive); 9. The subject has other conditions that, in the judgment of the investigator, make participation in this clinical study inappropriate.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Exendin-4 Fc fusion protein injection
1.2mg, subcutaneous injection in the abdomen, biweekly, 54 weeks of treatment.
• Exendin-4 Fc fusion protein injection
The first dose of 1.2 mg was administered subcutaneously in the abdomen, and after two weeks, the dose was adjusted to 2.4 mg, followed by a continuation of treatment for 52 weeks.
• Placebo
0.6 ml, placebo injection, biweekly subcutaneous abdominal injections for 26 weeks (core treatment period), after which placebo was randomized 1:1 to JY09 (1.2 mg) and JY09 (2.4 mg) continued subcutaneous abdominal injections biweekly for 28 weeks (extended treatment period).

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Dongfang Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Change in glycated hemoglobin (HbA1c) values relative to baseline after 26 weeks of treatment.	Baseline, Week 26
Secondary	The proportion of HbA1c <6.5% and <7%	Proportion of subjects with HbA1c <7% and HbA1c <6.5% after 26 and 54 weeks of treatment.	Baseline, Week 26,Week 54
Secondary	HbA1c	Change in HbA1c relative to baseline after 6, 10, 14, 20, 38, and 54 weeks of treatment.	Baseline, Week 6,Week 10,Week 14,Week 20,Week 38,Week 54
Secondary	fasting plasma glucose (FPG)	Change in fasting plasma glucose (FPG) relative to baseline after 6, 10, 14, 20, 38, and 54 weeks of treatment.	Baseline, Week 6,Week 10,Week 14,Week 20,Week 38,Week 54
Secondary	fasting insulin	Change in fasting insulin relative to baseline after 14, 26, and 54 weeks of treatment.	Baseline, Week 14,Week 26,Week 54
Secondary	Homeostatic Model Assessment of Insulin Resistance(HOMA-IR)	Change in HOMA-IR relative to baseline after 26 and 54 weeks of treatment.	Baseline,Week 26,Week 54
Secondary	Health Survey Short Form (SF-36)	Value of change in Health Survey Short Form (SF-36) scores relative to baseline after 26 and 54 weeks of treatment.	Baseline,Week 26,Week 54
Secondary	blood pressure	Change in blood pressure (sitting) relative to baseline after 26 and 54 weeks of treatment.	Baseline,Week 26,Week 54