T2DM (Type 2 Diabetes Mellitus)
Conditions
Brief summary
This randomized, double-blind, placebo-controlled Phase II study is designed to evaluate the efficacy, safety, and tolerability of ASC30 oral tablets formulation in participants with Type 2 Diabetes Mellitus
Interventions
DRUGASC30 tablets
ASC30 tablets administered orally once daily
DRUGPlacebo
Placebo administered orally once daily
Sponsors
Ascletis Pharma (China) Co., Limited
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
* Have Type 2 Diabetes (T2D) * Have HbA1c ≥7.0% to ≤10.5% as determined by the central laboratory at screening. * Stable body weight (less than 5% self-reported change within the previous 3 months). * Have a BMI ≥23.0 kilogram/square meter (kg/m²) at screening.
Exclusion criteria
* Have any prior diagnosis of type 1 diabetes mellitus (T1DM), or rare forms of diabetes mellitus * Have had more than 1 episode of severe hypoglycemia * Have poorly controlled hypertension * Have acute or chronic hepatitis and pancreatitis * Have evidence of a significant active and uncontrolled medical condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in HbA1c up to 13 weeks in the treatment group compared with the placebo group | Baseline and end of Week 13 |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline in fasting blood glucose up to 13 weeks in the treatment group compared with the placebo group | Baseline and end of Week 13 |
| Mean change from baseline in body weight up to 13 weeks in the treatment group compared with placebo group | Baseline and end of Week 13 |
Countries
United States
Outcome results
None listed