| Trial ID: | L3411 |
| Source ID: | NCT02317796
|
| Associated Drug: |
Mlr-1023
|
| Title: |
Adult Subjects With Uncontrolled Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: MLR-1023
|
| Outcome Measures: |
Primary: Change in PPG AUC0-3h in a MMTT between Days 1 and 29., 29 Days | Secondary: Change in fasting plasma glucose in dose groups from Day 1 to Day 29, Day 36, 36 Days|Change in fructosamine level from Day 1 to Day 29, 29 Days|Change in fasting insulin from Day 1 to Day 29, 29 Days|Change in glycated albumin from Day 1 to Day 29, 29 Days|Change from Day 1 to Day 29 in insulin sensitivity using HOMA-R (HOMA-R = fasting plasma insulin (mU/l) * fasting plasma glucose (mmol/l) / 22.5), 29 Days|Changes from Day 1 to Day 29 in beta-cell function using HOMA-B (HOMA-B = 20 * fast- ing plasma insulin (mU/l) / [fasting plasma glucose (mmol/l) - 3.5]), 29 Days|Change in HbA1C between Days 1 and Day 29, 29 Days|Changes in LDL-C, HDL-C, TG between Days 1 and Day 29, 29 Days|Change in weight between Days 1 and Day 29, 29 Days|Differences between placebo and MLR-1023 dose groups in PPG AUC0-3h Days 1 and 29., 29 Days
|
| Sponsor/Collaborators: |
Sponsor: Melior Pharmaceuticals | Collaborators: Bukwang Pharmaceutical, Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
149
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-12
|
| Completion Date: |
2016-02
|
| Results First Posted: |
|
| Last Update Posted: |
2016-09-26
|
| Locations: |
Melior Pharmaceuticals I & Bukwang Pharm. Co., Ltd., USA and South Korea, Pennsylvania, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02317796
|
