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

Saxagliptin Triple Oral Therapy

Phase 3

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Saxagliptin
Drug: Placebo

First Posted Date: 2010-05-21

Last Posted Date: 2012-08-10

Lead Sponsor: AstraZeneca

Target Recruit Count: 257

Registration Number: NCT01128153

Locations: 🇬🇧
Research Site, Wellingborough, United Kingdom

Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications

Phase 4

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Saxagliptin
Drug: Placebo

First Posted Date: 2010-04-21

Last Posted Date: 2014-07-17

Lead Sponsor: AstraZeneca

Target Recruit Count: 18206

Registration Number: NCT01107886

Locations: 🇬🇧
Research Site, Whitstable, United Kingdom

Bioequivalence Study of Fixed Dose Combination of 2.5 mg Saxagliptin/850 mg Metformin Tablet Relative to 2.5 mg Onglyza and 850 mg Glucophage Tablets Co-Administered

Phase 1

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: saxagliptin + metformin (FDC tablet)
Drug: saxagliptin
Drug: metformin

First Posted Date: 2010-02-15

Last Posted Date: 2015-05-08

Lead Sponsor: AstraZeneca

Target Recruit Count: 24

Registration Number: NCT01068743

Locations: 🇺🇸
PPD Development, LP, Austin, Texas, United States

Saxagliptin Compared to Glimepiride in Elderly Type 2 Diabetes Patients, With Inadequate Glycemic Control on Metformin

Phase 4

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Saxagliptin
Drug: Glimepiride

First Posted Date: 2009-11-03

Last Posted Date: 2013-11-28

Lead Sponsor: AstraZeneca

Target Recruit Count: 957

Registration Number: NCT01006603

Locations: 🇬🇧
Research Site, Wellingborough, United Kingdom

Efficacy and Tolerability of Saxagliptin add-on Compared to Uptitration of Metformin in Patients With Type 2 Diabetes

Phase 4

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Saxagliptin
Drug: Metformin

First Posted Date: 2009-11-03

Last Posted Date: 2012-01-19

Lead Sponsor: AstraZeneca

Target Recruit Count: 286

Registration Number: NCT01006590

Locations: 🇬🇧
Research Site, Peterborough, United Kingdom

An 18 Week Efficacy and Safety Study of Saxagliptin and Metformin XR Combination in Subjects With Type 2 Diabetes

Phase 3

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Saxagliptin
Drug: Metformin XR

First Posted Date: 2009-08-17

Last Posted Date: 2011-09-27

Lead Sponsor: AstraZeneca

Target Recruit Count: 282

Registration Number: NCT00960076

Locations: 🇵🇪
Research Site, Lima, Peru

Study of Multiple Doses of Saxagliptin (BMS-477118)

Phase 2

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Placebo
Drug: Saxagliptin

First Posted Date: 2009-08-03

Last Posted Date: 2015-04-03

Lead Sponsor: AstraZeneca

Target Recruit Count: 423

Registration Number: NCT00950599

Pharmacokinetics and Pharmacodynamics Study of Saxagliptin in Healthy Subjects

Phase 1

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Saxagliptin

First Posted Date: 2009-07-09

Last Posted Date: 2015-05-05

Lead Sponsor: AstraZeneca

Target Recruit Count: 12

Registration Number: NCT00935467

Locations: 🇺🇸
Ppd Development, Lp, Austin, Texas, United States

Evaluate Saxagliptin in Adult Indian Patients With Type 2 Diabetes Inadequate Glycemic Control

Phase 3

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Saxagliptin
Drug: Placebo

First Posted Date: 2009-06-11

Last Posted Date: 2011-09-26

Lead Sponsor: AstraZeneca

Target Recruit Count: 213

Registration Number: NCT00918879

Locations: 🇮🇳
Research Site, Maharashtra, Pune, India

Study To Evaluate 24 Hour Blood Sugar Control (24-hour Mean Weighted Glucose) In Subjects That Are Taking Saxagliptin 5 mg Added Onto Metformin XR 1500 XR mg Compared To Subjects Taking Metformin XR 1500 mg Up-titrated To Metformin XR 2000 mg

Phase 3

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Saxagliptin
Drug: Metformin XR
Drug: Placebo matching Saxagliptin
Drug: Placebo matching Metformin XR

First Posted Date: 2009-06-11

Last Posted Date: 2015-05-21

Lead Sponsor: AstraZeneca

Target Recruit Count: 219

Registration Number: NCT00918138

Locations: 🇺🇸
Dedicated Phase I, Inc., Phoenix, Arizona, United States
🇺🇸
Palm Springs Research Institute, Hialeah, Florida, United States
🇺🇸
River Birch Research Alliance, Llc, Blue Ridge, Georgia, United States

and more 10 locations

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