Long-Term Safety Study of MT-2412 in Japanese Patients With Type 2 Diabetes
|ClinicalTrials.gov Identifier: NCT02220907|
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : August 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: Teneligliptin/Canagliflozin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||153 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Long-term Administration Study of MT-2412 in Patients With Type 2 Diabetes Mellitus|
|Study Start Date :||August 2014|
|Primary Completion Date :||February 2016|
|Study Completion Date :||February 2016|
Patients will receive Teneligliptin and Canagliflozin once daily for 52 weeks.
Co-administration of Teneligliptin and Canagliflozin orally once daily for 52 weeks.
- Number of participants with adverse events [ Time Frame: 52 weeks ]
- Change from baseline in HbA1c [ Time Frame: Baseline and 52 weeks ]The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 52.
- Change from baseline in Fasting Plasma Glucose [ Time Frame: Baseline and 52 weeks ]The change from Baseline in Fasting Plasma Glucose collected at Week 52.
- Change from baseline in Body Weight [ Time Frame: Baseline and 52 weeks ]The change from Baseline in Body Weight collected at Week 52.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220907
|Study Director:||Takashi Kadowaki, MD||Tokyo University|
|Study Director:||Nobuya Inagaki, MD||Kyoto University|
|Study Director:||Kazuoki Kondo, MD||Mitsubishi Tanabe Pharma Corporation|