Type 2 Diabetes
Conditions
Brief 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).
Interventions
DRUGHEC88473, Placebo, Dulaglutide
T2DM subjects, receiving a weekly dose of HEC88473, placebo or dulaglutide.
Sponsors
Dongguan HEC Biopharmaceutical R&D Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of HbA1c at week 12 | Baseline to week 12 | HbA1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of weight at week 12 | Baseline to week 12 | weight |
| Change from baseline of fasting blood-glucose at week 12 | Baseline to week 12 | fasting blood-glucose |
| Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline to week 15 | Adverse Events (AEs) and Serious Adverse Events (SAEs) |
Countries
China
Outcome results
None listed