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

Study on Exploring the Effect of DPP-4 Inhibitors on β-cell Function by Using the Two-step Hyperglycemic Clamp

Phase 4
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2015-03-12
Last Posted Date
2015-03-12
Lead Sponsor
Shanghai Jiao Tong University School of Medicine
Target Recruit Count
12
Registration Number
NCT02386943
Locations
🇨🇳

Shanghai Jiao Tong University School of Medicine, Shanghai, China

Combining Saxagliptin and Acarbose to Improve Postprandial Glycaemia in Type 2 Diabetes

Phase 3
Completed
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2014-12-12
Last Posted Date
2018-07-06
Lead Sponsor
Zilin Sun
Target Recruit Count
22
Registration Number
NCT02315495
Locations
🇨🇳

Department of Endocrinology, Zhongda Hospital. Institute of Diabetes, Southeast University, Nanjing, Jiangsu, China

The Effect of Saxagliptin on Glucose Fluctuation and Immune Regulation in Patients With Type 1 Diabetes

Phase 4
Conditions
Type 1 Diabetes
Interventions
First Posted Date
2014-12-04
Last Posted Date
2016-07-06
Lead Sponsor
Nanjing Medical University
Target Recruit Count
184
Registration Number
NCT02307695
Locations
🇨🇳

First Affiliated Hospital, Nanjing Medical University, Nanjing, Jiangsu, China

Saxagliptin in Combination With Dapagliflozin - Effects on Islet Cell Function

Phase 4
Completed
Conditions
Type2 Diabetes Mellitus
Interventions
First Posted Date
2014-12-01
Last Posted Date
2018-06-20
Lead Sponsor
Prof. Dr. Thomas Forst
Target Recruit Count
64
Registration Number
NCT02304081
Locations
🇩🇪

Profil Mainz GmbH & Co. KG, Mainz, Germany

Effects of Saxagliptin on Adipose Tissue Inflammation in Humans

Phase 4
Completed
Conditions
Type 2 Diabetes Mellitus (T2DM)
Interventions
Drug: Placebo
First Posted Date
2014-11-07
Last Posted Date
2024-07-22
Lead Sponsor
Phoenix VA Health Care System
Target Recruit Count
103
Registration Number
NCT02285985
Locations
🇺🇸

Carl T. Hayden VA Medical Hospital, Phoenix, Arizona, United States

Efficacy and Safety of Saxagliptin VS. Glimepiride in Chinese T2DM Patients Controlled Inadequately With Metformin

Phase 4
Completed
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2014-10-31
Last Posted Date
2018-07-23
Lead Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Target Recruit Count
388
Registration Number
NCT02280486
Locations
🇨🇳

at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University, Nanjing, Jiangsu, China

Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Drug Naive Chinese Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: Placebo 5 mg for Saxagliptin
Drug: Placebo 500 mg for metformin (with titration)
First Posted Date
2014-10-23
Last Posted Date
2018-02-05
Lead Sponsor
AstraZeneca
Target Recruit Count
1136
Registration Number
NCT02273050
Locations
🇨🇳

Research Site, Yueyang, China

24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin Compared With Acarbose When in Combination With Metformin in Patients With T2D Inadequately Controlled With Metformin Monotherapy

Phase 4
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2014-09-17
Last Posted Date
2017-04-14
Lead Sponsor
AstraZeneca
Target Recruit Count
689
Registration Number
NCT02243176
Locations
🇨🇳

Research Site, Shanghai, China

DPP-IV Inhibition Prior to Development of Diabetes in Patients With Cystic Fibrosis

Not Applicable
Conditions
Cystic Fibrosis
Interventions
First Posted Date
2014-09-12
Last Posted Date
2015-04-16
Lead Sponsor
Ram Weiss
Target Recruit Count
60
Registration Number
NCT02239458
Locations
🇮🇱

Hadassah Ein Kerem/Har Hazofim, Jerusalem, Israel

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