MedPath

Saxagliptin

Generic Name
Saxagliptin
Brand Names
Kombiglyze, Komboglyze, Onglyza, Qtern, Qternmet
Drug Type
Small Molecule
Chemical Formula
C18H25N3O2
CAS Number
361442-04-8
Unique Ingredient Identifier
8I7IO46IVQ
Background

Saxagliptin (rINN) is an orally active hypoglycemic (anti-diabetic drug) of the new dipeptidyl peptidase-4 (DPP-4) inhibitor class of drugs. FDA approved on July 31, 2009.

Indication

Treatment of type 2 diabetes mellitus to improve glycemic control in combination with other agents or as monotherapy.

Associated Conditions
Type 2 Diabetes Mellitus

Safety and Efficacy of Dapagliflozin in Asian T2DM Subjects With Inadequate Glycemic Control on Metformin/Saxagliptin

First Posted Date
2018-07-31
Last Posted Date
2022-05-31
Lead Sponsor
AstraZeneca
Target Recruit Count
41
Registration Number
NCT03608358
Locations
🇻🇳

Research Site, Ho Chi Minh, Vietnam

Study to Evaluate Safety and Efficacy of Dapagliflozin and Saxagliptin in Patients With Type 2 Diabetes Mellitus (T2DM) Aged 10 to Below 18 Years Old

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2017-06-26
Last Posted Date
2024-06-21
Lead Sponsor
AstraZeneca
Target Recruit Count
256
Registration Number
NCT03199053
Locations
🇬🇧

Research Site, Nottingham, United Kingdom

Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)

Not Applicable
Recruiting
Conditions
Diabetes Mellitus, Type 2
Impaired Fasting Glucose (IFG)
Impaired Glucose Tolerance (IGT)
Interventions
First Posted Date
2016-11-21
Last Posted Date
2024-08-07
Lead Sponsor
The University of Texas Health Science Center at San Antonio
Target Recruit Count
700
Registration Number
NCT02969798
Locations
🇺🇸

The University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States

Study About Effect of Saxagliptin on Circulating Endothelial Progenitor Cells and Endothelial Function in Newly Diagnosed Type 2 Diabetic Patients

Phase 4
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2016-09-30
Last Posted Date
2016-10-03
Lead Sponsor
Shanghai Zhongshan Hospital
Target Recruit Count
31
Registration Number
NCT02920801
Locations
🇨🇳

Fang Li, Shanghai, Shanghai, China

Mechanistic Evaluation of Glucose-lowering Strategies in Patients With Heart Failure

Phase 4
Completed
Conditions
Heart Failure
Type 2 Diabetes Mellitus
Interventions
Drug: Placebo to match saxagliptin
Drug: Placebo to match sitagliptin
First Posted Date
2016-09-28
Last Posted Date
2021-11-08
Lead Sponsor
AstraZeneca
Target Recruit Count
348
Registration Number
NCT02917031
Locations
🇺🇦

Research Site, Rivne, Ukraine

A Single-dose Cross-over Study to Assess Direct and Indirect Effects of Dapagliflozin on Pancreatic Alpha and Beta Cells in Patients With Type 2 Diabetes

Phase 4
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2016-05-06
Last Posted Date
2016-12-12
Lead Sponsor
Uppsala University
Target Recruit Count
15
Registration Number
NCT02765204
Locations
🇸🇪

Dept of Medical Sciences Uppsala University Hospital, Uppsala, Sweden

Dipeptidyl Peptidase 4 Inhibition Facilitate Healing of Diabetic Ulcers

Phase 4
Conditions
Diabetic Foot Ulcer
Interventions
Drug: placebo
First Posted Date
2016-04-18
Last Posted Date
2017-08-08
Lead Sponsor
Long Min,MD
Target Recruit Count
60
Registration Number
NCT02742233
Locations
🇨🇳

The Second Affiliated Hospital, Third Military Medical University, Chongqing, Chongqing, China

A Multi-Center, Randomized, Double-Blind, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Saxagliptin or Dapagliflozin All Given as add-on Therapy to Metformin in Subject With Type 2 Diabetes

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Inadequate Glycaemic Control
Interventions
First Posted Date
2016-02-12
Last Posted Date
2018-10-10
Lead Sponsor
AstraZeneca
Target Recruit Count
905
Registration Number
NCT02681094
Locations
🇷🇺

Research Site, Vladikavkaz, Russian Federation

ESR-15-11293 - Saxa/Dapa, Safety and Efficacy Study

Not Applicable
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2015-11-25
Last Posted Date
2019-08-14
Lead Sponsor
The University of Texas Health Science Center at San Antonio
Target Recruit Count
56
Registration Number
NCT02613897
Locations
🇺🇸

The University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States

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