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

Associated Therapies: -

Clinical Trials

Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (B)

Phase 1

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Saxagliptin
Drug: Saxagliptin + Metformin IR (FDC)
Drug: Metformin IR (glucophage)

First Posted Date: 2009-05-12

Last Posted Date: 2015-05-21

Lead Sponsor: AstraZeneca

Target Recruit Count: 24

Registration Number: NCT00897390

Locations: 🇺🇸
Mds Pharma Services, Lincoln, Nebraska, United States

A Phase 2 Study of OPC-262 in Patients With Type 2 Diabetes

Phase 2

Completed

Conditions: Diabetes, Type 2

Interventions: Drug: placebo
Drug: saxagliptin

First Posted Date: 2009-03-06

Last Posted Date: 2017-03-09

Lead Sponsor: Kyowa Kirin Co., Ltd.

Target Recruit Count: 350

Registration Number: NCT00857558

Assess Pharmacokinetics, Safety and Tolerability in Healthy Chinese Volunteers After Oral Doses of Saxagliptin

Phase 1

Completed

Conditions: Type 2 Diabetes

First Posted Date: 2008-10-09

Last Posted Date: 2009-07-09

Lead Sponsor: AstraZeneca

Target Recruit Count: 34

Registration Number: NCT00770302

Locations: 🇨🇳
Research Site, Beijing, China

Evaluate Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Inadequate Glycemic Control

Phase 3

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Saxagliptin
Drug: Placebo

First Posted Date: 2008-06-17

Last Posted Date: 2011-09-21

Lead Sponsor: AstraZeneca

Target Recruit Count: 568

Registration Number: NCT00698932

Locations: 🇵🇭
Research Site, Quezon City, Philippines

Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone

Phase 3

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Placebo
Drug: Saxagliptin

First Posted Date: 2008-05-23

Last Posted Date: 2015-06-01

Lead Sponsor: AstraZeneca

Target Recruit Count: 93

Registration Number: NCT00683657

Locations: 🇺🇸
Endocrine Research Solutions, Inc., Roswell, Georgia, United States
🇺🇸
Dedicated Phase I, Inc., Phoenix, Arizona, United States
🇺🇸
Orange County Research Center, Tustin, California, United States

and more 11 locations

18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D)

Phase 3

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: saxagliptin
Drug: sitagliptin

First Posted Date: 2008-04-25

Last Posted Date: 2010-04-15

Lead Sponsor: AstraZeneca

Target Recruit Count: 822

Registration Number: NCT00666458

Locations: 🇸🇪
Research Site, Umea, Sweden

Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes

Phase 3

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Placebo
Drug: Saxagliptin
Drug: Metformin

First Posted Date: 2008-04-18

Last Posted Date: 2012-03-08

Lead Sponsor: AstraZeneca

Target Recruit Count: 570

Registration Number: NCT00661362

Locations: 🇰🇷
Research Site, Uijeongbu-si, Korea, Republic of

Treatment Effect of Saxagliptin Compared With Placebo in Patients With Type 2 Diabetes and Renal Impairment

Phase 3

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Saxagliptin
Drug: Placebo

First Posted Date: 2008-02-13

Last Posted Date: 2011-05-19

Lead Sponsor: AstraZeneca

Target Recruit Count: 572

Registration Number: NCT00614939

Locations: 🇺🇦
Research Site, Zaporizhzhya, Ukraine

52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period

Phase 3

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Metformin
Drug: Sulphonylurea
Drug: Saxagliptin

First Posted Date: 2007-12-18

Last Posted Date: 2012-03-21

Lead Sponsor: AstraZeneca

Target Recruit Count: 891

Registration Number: NCT00575588

Locations: 🇻🇳
Research Site, Ho Chi Minh, Vietnam

A Study Assessing Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

Phase 3

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Placebo
Drug: Saxagliptin
Drug: Metformin (blinded)
Drug: Metformin (open-label)

First Posted Date: 2006-09-12

Last Posted Date: 2015-05-07

Lead Sponsor: AstraZeneca

Target Recruit Count: 156

Registration Number: NCT00374907

Locations: 🇺🇸
Diabetes & Glandular Disease Research Assoc,, Inc., San Antonio, Texas, United States
🇺🇸
Va San Diego Healthcare System, San Diego, California, United States
🇺🇸
Pennington Biomedical Research Center, Baton Rouge, Louisiana, United States

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