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Alogliptin

Generic Name
Alogliptin
Brand Names
Incresync, Kazano, Nesina, Oseni, Vipidia
Drug Type
Small Molecule
Chemical Formula
C18H21N5O2
CAS Number
850649-61-5
Unique Ingredient Identifier
JHC049LO86
Background

Alogliptin is a selective, orally-bioavailable inhibitor of enzymatic activity of dipeptidyl peptidase-4 (DPP-4). Chemically, alogliptin is prepared as a benzoate salt and exists predominantly as the R-enantiomer (>99%). It undergoes little or no chiral conversion in vivo to the (S)-enantiomer. FDA approved January 25, 2013.

Indication

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Associated Conditions
Type 2 Diabetes Mellitus

SAL067 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2023-03-23
Last Posted Date
2023-03-23
Lead Sponsor
Shenzhen Salubris Pharmaceuticals Co., Ltd.
Target Recruit Count
458
Registration Number
NCT05782192
Locations
🇨🇳

1. Sun Yat-sen Memorial Hospital, Sun Yat-sen University,, Guangzhou, Guangdong, China

A Bioequivalence Study of CT-L01 Compared to Co-administration (ALO 12.5 mg and MET XR 500 mg) in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2022-05-06
Last Posted Date
2023-01-12
Lead Sponsor
Celltrion
Target Recruit Count
48
Registration Number
NCT05363592
Locations
🇰🇷

Chungnam National University Hospital, Daejeon, Korea, Republic of

A Bioequivalence Study of CT-L01 Compared to Co-administration (ALO 25 mg and MET XR 1,000 mg) in Healthy Volunteers

First Posted Date
2022-05-05
Last Posted Date
2023-01-12
Lead Sponsor
Celltrion
Target Recruit Count
48
Registration Number
NCT05363384
Locations
🇰🇷

Chungnam National University Hospital, Daejeon, Korea, Republic of

A Study for Post-Marketing Surveillance of Nesina® Tablet Monotherapy or Combination Therapy in Participants With Type 2 Diabetes (T2DM) in South Korea

Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2021-07-28
Last Posted Date
2022-04-05
Lead Sponsor
Takeda
Target Recruit Count
3623
Registration Number
NCT04980040

Glimepiride, Alogliptin and Alogliptin+Pioglitazone Combination

Phase 4
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: Alogliptin-Pioglitazone 25 Mg-15 Mg Oral Tablet
First Posted Date
2020-07-14
Last Posted Date
2020-10-22
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
99
Registration Number
NCT04470310

Efficacy and Safety of Alogliptin vs. Acarbose in Chinese Type 2 Diabetes Mellitus (T2DM) Patients With High CV Risk or CHD Treated With Aspirin and Inadequately Controlled With Metformin Monotherapy or Drug Naive

Phase 4
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2019-01-07
Last Posted Date
2022-04-25
Lead Sponsor
Sanofi
Target Recruit Count
1293
Registration Number
NCT03794336
Locations
🇨🇳

CHINA, China, China

Specified Drug-Use Survey of Alogliptin and Metformin Hydrochloride Combination Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Renal or Hepatic Impairment or Advanced Age"

Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2018-06-13
Last Posted Date
2023-09-13
Lead Sponsor
Takeda
Target Recruit Count
1026
Registration Number
NCT03555565
Locations
🇯🇵

Takeda Selected Site, Tokyo, Japan

A Study to Determine the Bioequivalence of Alogliptin and Pioglitazone When Administered as Individual Tablets and as Fixed-Dose Combination (FDC)-SYR-322-4833 BL Tablets to Healthy Russian Participants

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2018-04-18
Last Posted Date
2019-08-08
Lead Sponsor
Takeda
Target Recruit Count
72
Registration Number
NCT03501277
Locations
🇷🇺

Non-governmental healthcare Institution Road Clinical Hospital at the station Yaroslavl JSC Russian Railways, Yaroslavl, Russian Federation

A Study to Evaluate the Effect of add-on Pioglitazone or Dapagliflozin in Participants With Type 2 Diabetes Mellitus Inadequately Controlled by DPP-4 Inhibitor and Metformin Therapy

Phase 4
Active, not recruiting
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2018-04-17
Last Posted Date
2023-08-30
Lead Sponsor
Celltrion Pharm, Inc.
Target Recruit Count
133
Registration Number
NCT03499704
Locations
🇰🇷

The Catholic University of Korea, Bucheon, St. Marys Hospital, Bucheon-si, Gyeonggi-do, Korea, Republic of

🇰🇷

Ajou University Hospital, Suwon, Gyeonggi-do, Korea, Republic of

🇰🇷

The Catholic University of Korea, ST. Vincents Hospital, Suwon-si, Gyeonggi-do, Korea, Republic of

and more 12 locations

Treatment Preference for Weekly Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Versus Daily DPP-4 Inhibitors in Participants With Type 2 Diabetes Mellitus

Phase 4
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2017-07-27
Last Posted Date
2023-12-22
Lead Sponsor
Takeda
Target Recruit Count
60
Registration Number
NCT03231709
Locations
🇯🇵

OCROM Clinic, Suita, Osaka, Japan

🇯🇵

ToCROM Clinic, Shinjuku, Tokyo, Japan

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