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

Bioequivalence Study Coadministered to Healthy Subjects in the Fasted State

Phase 1
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2014-08-22
Last Posted Date
2016-04-27
Lead Sponsor
AstraZeneca
Target Recruit Count
36
Registration Number
NCT02223065

Safety and Efficacy of Saxagliptin for Glycemic Control in Non-Critically Ill Hospitalized Patient

Phase 4
Completed
Conditions
Diabetes Mellitus
Interventions
First Posted Date
2014-07-08
Last Posted Date
2017-06-23
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
72
Registration Number
NCT02182895
Locations
🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

Cystic Fibrosis Related Diabetes

Not Applicable
Conditions
Cystic Fibrosis
Interventions
First Posted Date
2014-05-29
Last Posted Date
2014-05-29
Lead Sponsor
Ram Weiss
Target Recruit Count
30
Registration Number
NCT02148978
Locations
🇮🇱

Hadassah Har Hazofim, Jerusalem, Israel

Effects of Antidiabetic Medications on the Postprandial State in Prediabetes

Phase 4
Completed
Conditions
Prediabetes
Obesity
Interventions
First Posted Date
2014-04-04
Last Posted Date
2018-07-03
Lead Sponsor
The University of Texas Health Science Center, Houston
Target Recruit Count
21
Registration Number
NCT02104739
Locations
🇺🇸

The University of Texas Health Science Center at Houston, Houston, Texas, United States

Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin Combined With Metformin in Chinese Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2014-04-04
Last Posted Date
2017-10-02
Lead Sponsor
AstraZeneca
Target Recruit Count
953
Registration Number
NCT02104804
Locations
🇨🇳

Research Site, Shiyan, China

DPP-4 Inhibition, Incretins and Islet Function

Phase 4
Completed
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2014-03-17
Last Posted Date
2017-08-23
Lead Sponsor
Lund University
Target Recruit Count
24
Registration Number
NCT02089438
Locations
🇸🇪

Clinical Research Department, Lund, Sweden

Bioequivalence/Food Effect - Saxa/Dapa Dual Fixed Dose Combination (FDC)

Phase 1
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: Saxagliptin/Dapagliflozin FDC
First Posted Date
2014-02-11
Last Posted Date
2015-06-10
Lead Sponsor
AstraZeneca
Target Recruit Count
72
Registration Number
NCT02060201

Effect of Saxagliptin on EPCs as a Cellular Biomarker for Evaluating Endothelial Dysfunction in Early T2DM Patients

Phase 4
Completed
Conditions
Type 2 Diabetes
Interventions
Drug: Placebo
First Posted Date
2013-12-31
Last Posted Date
2019-02-15
Lead Sponsor
George Washington University
Target Recruit Count
42
Registration Number
NCT02024477
Locations
🇺🇸

Medical Faculty Associates Inc, Washington, District of Columbia, United States

Saxagliptin + Metformin Compared to Saxagliptin or Metformin Monotherapy in PCOS Women With Impaired Glucose Homeostasis

Phase 3
Completed
Conditions
Disorder of Glucose Regulation
Polycystic Ovary Syndrome
Interventions
Drug: Saxagliptin-Metformin XR
First Posted Date
2013-12-27
Last Posted Date
2017-06-28
Lead Sponsor
Woman's
Target Recruit Count
38
Registration Number
NCT02022007
Locations
🇺🇸

Woman's Hospital, Baton Rouge, Louisiana, United States

Effect of Saxagliptin on Pre-Diabetes Mellitus and Obesity

Phase 4
Conditions
Prediabetes
Interventions
Other: lifestyle intervention
First Posted Date
2013-10-10
Last Posted Date
2014-09-25
Lead Sponsor
Shandong Provincial Hospital
Target Recruit Count
80
Registration Number
NCT01960205
Locations
🇨🇳

Shandong Provincial Hospital, Jinan, Shandong, China

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