Long-Term Safety Study of MT-2412 in Japanese Patients With Type 2 Diabetes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02220907|
Recruitment Status : Completed
First Posted : August 20, 2014
Results First Posted : August 16, 2018
Last Update Posted : August 16, 2018
|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|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
Patients 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, 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, 52 Weeks ]The change from Baseline in Fasting Plasma Glucose collected at Week 52.
- Change From Baseline in Body Weight [ Time Frame: Baseline, 52 Weeks ]The change from Baseline in Body Weight collected at Week 52.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|