| Trial ID: | L6056 |
| Source ID: | NCT02561338
|
| Associated Drug: |
Hms5552
|
| Title: |
A Multi-center 12-week Study of HMS5552 in T2DM
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02561338/results
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: HMS5552|DRUG: HMS5552|DRUG: HMS5552|DRUG: HMS5552|OTHER: Placebo
|
| Outcome Measures: |
Primary: After 12-week Treatment, the Change From Baseline in HbA1c, Assess the percentage of Hemoglobin A1c (HbA1c) changes at week 12. In the group HMS5552 dose3, a subject without follow-up data for HbA1c available was excluded. And in the group HMS5552 dose4, two subjects without follow-up data for HbA1c available were excluded. So the overall number of baseline participants is not consistent with numbers provided in any of the rows in the participant flow module., Baseline and 12 weeks | Secondary: Change From Baseline in 2hPPG, Using a standard meal tolerance test, to assess 2-h postprandial glucose (2hPPG). In this test, subjects were received meals standardised by China National Cereals, which supplied by Oils and Foodstuffs Corporation and contained 353 kcal, 75 g carbohydrate, 1.48 g fat, and 8.0 g protein. Collect the blood samples to detect blood glucose 2 hours after starting the meal., Baseline and 12 weeks|Change From Baseline in FPG, Baseline and 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Hua Medicine Limited | Collaborators: Tigermed Consulting Co., Ltd
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
258
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-09
|
| Completion Date: |
2016-09
|
| Results First Posted: |
2020-03-10
|
| Last Update Posted: |
2020-03-10
|
| Locations: |
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China
|
| URL: |
https://clinicaltrials.gov/show/NCT02561338
|
