Phase 2 Study of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus

Type 2 Diabetes Clinical Trial

Official title:

A Phase 2, Multicenter, Randomised, Paralleled, Placebo-controlled (Double-blind) and Active Drug-controlled (Open) Study to Investigate Efficacy and Safety of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06148649
• Other study ID #: HEC88473-DM-201
• Status: Recruiting
• Phase: Phase 2
• Start date: December 10, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: November 2023
• Source: Dongguan HEC Biopharmaceutical R&D Co., Ltd.
• Contact: linong Ji, Doctor
• Phone: 13910978815
• Email: jiln[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, randomized, parallel, placebo- and active comparator-controlled phase 2 trial to evaluate the efficacy, safety, pharmacokinetics and immunogenicity in subjects with T2DM. Patients treated with diet and exercise alone, or in combination with stable metformin monotherapy (≥1500 mg/day or maximum tolerated dose ≥1000 mg/ day.), will be enrolled. Approximately 225 participants will be randomized. The study includes four stages: screening period (up to 2 weeks), lead-in period (2 weeks), treatment period (12 weeks) and safety follow-up period (3 weeks after treatment).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: September 30, 2024
• Est. primary completion date: September 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Male or female patients 18 to 75 years of age, inclusive.

2. Have T2DM for at least 3 months before screening based on the disease diagnostic criteria (WHO 1999).

3. Have an HbA1c value of =7.5% and =10.5%, fasting blood-glucose =13.9 mmoL/L, at screening and visit 3.

Exclusion Criteria:

1. Have type 1 diabetes mellitus.

2. Have had =1 episode of severe hypoglycemia within 6 months before screening, or history of recurrent hypoglycemia (history of hypoglycemia more than 3 times in 3 months).

3. Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level >2.5 times the upper limit of the reference range at screening.

4. Have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2) at screening.

5. Have serum calcitonin =20 ng/L at screening.

6. Fasted triglycerides > 5.7 mmol/L at screening.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• HEC88473, Placebo, Dulaglutide
T2DM subjects, receiving a weekly dose of HEC88473, placebo or dulaglutide.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Dongguan HEC Biopharmaceutical R&D Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of HbA1c at week 12	HbA1c	Baseline to week 12
Secondary	Change from baseline of weight at week 12	weight	Baseline to week 12
Secondary	Change from baseline of fasting blood-glucose at week 12	fasting blood-glucose	Baseline to week 12
Secondary	Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)	Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline to week 15