Saxagliptin

Generic Name: Saxagliptin

Brand Names: Kombiglyze, Komboglyze, Onglyza, Qtern, Qternmet

Drug Type: Small Molecule

Chemical Formula: C_₁₈H_₂₅N_₃O_₂

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

Clinical Trials

Safety and Efficacy of Acarbose+Saxagliptin Compared With Metformin+Saxagliptin in Patients With Type 2 Diabetes

Phase 4

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Metformin
Drug: Acarbose
Drug: Saxagliptin

First Posted Date: 2015-11-16

Last Posted Date: 2015-11-18

Lead Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University

Target Recruit Count: 100

Registration Number: NCT02605772

Anti-Inflammatory Small Drug Adjunctive Therapy for Type 2 Diabetes

Phase 2

Completed

Conditions: Insulin Resistance
Type 2 Diabetes Mellitus

Interventions: Drug: Metformin
Drug: saxagliptin
Drug: placebo
Drug: AZD9668

First Posted Date: 2015-11-05

Last Posted Date: 2021-05-13

Lead Sponsor: Nick Giannoukakis, PhD

Target Recruit Count: 14

Registration Number: NCT02597101

Locations: 🇺🇸
Allegheny Health Network, Pittsburgh, Pennsylvania, United States

Evaluate the Effect of Saxagliptin on Gut Microbiota in Patients With Newly Diagnosed Type 2 Diabetes

Phase 4

Conditions: Type 2 Diabetes
Obesity

Interventions: Drug: Saxagliptin (Bristol-Myers Squibb Company)

First Posted Date: 2015-10-22

Last Posted Date: 2015-10-22

Lead Sponsor: Beijing Chao Yang Hospital

Target Recruit Count: 100

Registration Number: NCT02583438

A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Saxagliptin, Onglyza
Drug: Glargine insulin
Drug: Dapagliflozin, Farxiga
Drug: Metformin

First Posted Date: 2015-09-16

Last Posted Date: 2018-12-11

Lead Sponsor: AstraZeneca

Target Recruit Count: 650

Registration Number: NCT02551874

Locations: 🇸🇪
Research Site, Uddevalla, Sweden

A Study to Evaluate the Effect of Dapagliflozin With and Without Saxagliptin on Albuminuria, and to Investigate the Effect of Dapagliflozin and Saxagliptin on HbA1c in Patients With Type 2 Diabetes and CKD

Phase 2

Completed

Conditions: Type 2 Diabetes Mellitus, CKD and Albuminuria

Interventions: Drug: Dapagliflozin 10 mg
Drug: Saxagliptin 2.5 mg
Drug: Matching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mg

First Posted Date: 2015-09-14

Last Posted Date: 2019-08-21

Lead Sponsor: AstraZeneca

Target Recruit Count: 459

Registration Number: NCT02547935

Locations: 🇨🇳
Research Site, Yong-Kang City, Taiwan

Saxagliptin and Cardiac Structure and Function

Phase 4

Completed

Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Heart Failure

Interventions: Drug: saxagliptin

First Posted Date: 2015-06-25

Last Posted Date: 2020-03-30

Lead Sponsor: Unity Health Toronto

Target Recruit Count: 18

Registration Number: NCT02481479

Locations: 🇨🇦
St Michael's Hospital, Toronto, Ontario, Canada

Efficacy and Safety of Dapagliflozin and Dapagliflozin Plus Saxagliptin in Combination With Metformin in Type 2 Diabetes Patients Compared With Sulphonylurea

Phase 4

Completed

Conditions: Type 2 Diabetes Mellitus
Inadequate Glycaemic Control

Interventions: Drug: Dapagliflozin
Drug: Glimepiride
Drug: Placebo for saxagliptin
Drug: Saxagliptin
Drug: Placebo for dapagliflozin
Drug: Placebo for glimepiride

First Posted Date: 2015-06-15

Last Posted Date: 2019-03-26

Lead Sponsor: AstraZeneca

Target Recruit Count: 939

Registration Number: NCT02471404

Locations: 🇸🇰
Research Site, Vrutky, Slovakia

Saxagliptin's Effects on Microalbuminuria Improvement in Type 2 Diabetic Patients

Phase 4

Conditions: Microalbuminuria /Creatinine Ratios ACR
Microalbuminuria

Interventions: Drug: Saxagliptin
Drug: glimepiride

First Posted Date: 2015-06-04

Last Posted Date: 2015-07-28

Lead Sponsor: The Second Hospital of Nanjing Medical University

Target Recruit Count: 88

Registration Number: NCT02462369

A 52-week International, Multicenter Trial With a Long -Term Extension to Evaluate Saxagliptin With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

Phase 3

Completed

Conditions: Diabetes

Interventions: Drug: Saxagliptin
Drug: Glimepiride
Drug: Dapagliflozin
Other: Placebo

First Posted Date: 2015-04-17

Last Posted Date: 2020-06-23

Lead Sponsor: AstraZeneca

Target Recruit Count: 444

Registration Number: NCT02419612

Locations: 🇬🇧
Research Site, Dundee, United Kingdom

Protective Effects of Saxagliptin (And Vitamin D3) on β Cell Function in Adult-onset Latent Autoimmune Diabetes

Phase 4

Completed

Conditions: Diabetes Mellitus, Type 1

Interventions: Drug: Insulin
Drug: Saxagliptin
Drug: Vitamin D3
Drug: Metformin

First Posted Date: 2015-04-03

Last Posted Date: 2021-04-20

Lead Sponsor: Second Xiangya Hospital of Central South University

Target Recruit Count: 300

Registration Number: NCT02407899

Locations: 🇨🇳
Gansu Provincial Hospital, Lanzhou, Gansu, China
🇨🇳
Guangdong General Hospital, Guangzhou, Guangdong, China
🇨🇳
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University, Changsha, Hunan, China

and more 36 locations

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