| Trial ID: | L7162 |
| Source ID: | NCT01301833
|
| Associated Drug: |
Teneligliptin
|
| Title: |
Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01301833/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: teneligliptin|DRUG: glinide|DRUG: biguanide|DRUG: alpha-glucosidase inhibitor
|
| Outcome Measures: |
Primary: Number of Participants With Adverse Events, Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug., 52 Weeks | Secondary: Change From Baseline in HbA1c at Week 52, Baseline and 52 weeks|Change From Baseline in Fasting Plasma Glucose at Week 52, Baseline and 52 weeks|Change From Baseline in Fasting Glucagon at Week 52, Baseline and 52 weeks|Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52, Baseline and 52 weeks
|
| Sponsor/Collaborators: |
Sponsor: Mitsubishi Tanabe Pharma Corporation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
462
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2011-02
|
| Completion Date: |
2012-09
|
| Results First Posted: |
2015-08-28
|
| Last Update Posted: |
2015-11-18
|
| Locations: |
Chitose-shi, Hokkaidou, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01301833
|
