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

Launched by DONGGUAN HEC BIOPHARMACEUTICAL R&D CO., LTD. · Nov 20, 2023

Keywords

ClinConnect Summary

This clinical trial is looking into a new medication called HEC88473 for people with Type 2 Diabetes Mellitus (T2DM). The goal is to see how effective and safe this injection is compared to a placebo (a fake treatment) and an active treatment that is already available. The study will involve around 225 participants who are currently managing their diabetes with diet and exercise or metformin, a common diabetes medication. The trial lasts about 17 weeks, which includes time for screening, treatment, and follow-up to check on safety.

To be eligible for the trial, participants must be between 18 and 75 years old and have been diagnosed with Type 2 Diabetes for at least three months. They should have specific blood sugar levels that fall within a certain range. However, individuals with Type 1 diabetes or a history of severe low blood sugar episodes may not qualify. Participants can expect to be monitored closely throughout the study, and their health will be checked regularly to ensure safety. This trial is currently recruiting, and it offers an opportunity to contribute to research that could help improve diabetes treatment in the future.

Gender

ALL

Eligibility criteria

• 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.