Phase 2
Completed N=258
A Multi-center 12-week Study of HMS5552 in T2DM
Source: ClinicalTrials.gov NCT02561338 ↗Enrolled (actual)
258
Serious AEs
1.2%
Results posted
Mar 2020
Primary outcomePrimary: After 12-week Treatment, the Change From Baseline in HbA1c — -0.39; -0.65; -0.79; -1.12 Percentage of glycated hemoglobin
Summary
This study evaluates the safety, tolerability, efficacy and population PK of HMS5552 in type 2 diabetic adult subjects,there will be 5 groups ,4 groups will receive HMS5552,while 1 will receive placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY After 12-week Treatment, the Change From Baseline in HbA1c |
-0.39; -0.65; -0.79; -1.12; -0.35 | — |
| SECONDARY Change From Baseline in 2hPPG |
-4.669; -4.945; -3.898; -4.899; -1.987 | — |
| SECONDARY Change From Baseline in FPG |
-0.307; -0.382; -0.758; -1.319; -0.801 | — |
Eligibility Criteria
Inclusion Criteria
- Male & female, 40~75 years old
- T2DM patients，anti-hyperglycemic drug-naïve and on diet & exercise for at least 3 months, or with glucose controlled by Metformin or α-glucosidase inhibitor alone
- HbA1c 7.5~10.5% at screening and pre-randomization
- Fasting plasma glucose (FPG)7.0~11.1 millimole/liter (mmol/L, local lab) at screening, and 7.0~13.3 millimole/liter (mmol/L, central lab) at pre-randomization
- BMI: 19~30kg/m^2 & TG<5.5mmol/L
Exclusion Criteria
- T1D，secondary DM, pre-DM
- kidney diseases or eGFR MDRD<60ml/min/1.73m^2
- unstable CVDs
- liver diseases
- mental or CNS diseases
Data sourced from ClinicalTrials.gov (NCT02561338). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.