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
- Associated Therapies
- -
Effects of DPP-4 Inhibition on Triglycerides
- First Posted Date
- 2012-02-07
- Last Posted Date
- 2023-04-07
- Lead Sponsor
- Oregon Health and Science University
- Target Recruit Count
- 15
- Registration Number
- NCT01527747
- Locations
- 🇺🇸
Oregon Health & Science University, Portland, Oregon, United States
Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM
- Conditions
- Interventions
- First Posted Date
- 2012-02-02
- Last Posted Date
- 2015-06-22
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 4
- Registration Number
- NCT01525225
- Locations
- 🇺🇸
Childrens Hospital Of Pittsburgh Of Upmc, Pittsburgh, Pennsylvania, United States
🇺🇸Promedica Toledo Children'S Hospital, Toledo, Ohio, United States
🇺🇸Axis Clinical Trials, Los Angeles, California, United States
ACute and Chronic Effects of Saxagliptin
- Conditions
- Interventions
- First Posted Date
- 2012-01-30
- Last Posted Date
- 2015-02-03
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Target Recruit Count
- 24
- Registration Number
- NCT01521312
- Locations
- 🇫🇷
Jean Verdier hospital, Department of Endocrinology-Diabetology-Nutrition, Bondy, France
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination With Metformin IR or Metformin XR in Pediatric Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
- Conditions
- Interventions
- First Posted Date
- 2011-09-14
- Last Posted Date
- 2017-04-18
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 32
- Registration Number
- NCT01434186
- Locations
- 🇬🇧
Research Site, Leicester, United Kingdom
Bioequivalence Study of Fixed-dose Combinations and Coadministered Individual Tablets of Saxagliptin/Metformin-Brazil
- First Posted Date
- 2011-06-03
- Last Posted Date
- 2015-05-08
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 112
- Registration Number
- NCT01365091
- Locations
- 🇧🇷
Local Institution, Campinas, Sao Paulo, Brazil
Effects of Saxagliptin on Endothelial Function
- First Posted Date
- 2011-03-21
- Last Posted Date
- 2014-02-12
- Lead Sponsor
- University of Erlangen-Nürnberg Medical School
- Target Recruit Count
- 52
- Registration Number
- NCT01319357
- Locations
- 🇩🇪
Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nuremberg, Erlangen, Germany
BE Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin HCl XR Tablet Relative to a 5 mg Saxagliptin (Onglyza™) Tablet and a 500 mg Metformin HCl XR (Glifage® XR Marketed in Brazil by Merck S.A.) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States
- Conditions
- Interventions
- First Posted Date
- 2011-02-28
- Last Posted Date
- 2014-06-05
- Lead Sponsor
- AstraZeneca
- Registration Number
- NCT01305551
- Locations
- 🇧🇷
Local Institution, Campinas, Sao Paulo, Brazil
Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin as Monotherapy in Pediatric Patients With Type 2 Diabetes
- Conditions
- Interventions
- First Posted Date
- 2010-09-17
- Last Posted Date
- 2017-04-18
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 26
- Registration Number
- NCT01204775
- Locations
- 🇨🇳
Research Site, Taipei, Taiwan
Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin/1000 mg Metformin XR (Manufactured in Mt Vernon, IN) Relative to 5 mg of Onglyza and 2 × 500 mg Glucophage XR
- Conditions
- Interventions
- First Posted Date
- 2010-08-31
- Last Posted Date
- 2015-05-12
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 30
- Registration Number
- NCT01192152
- Locations
- 🇺🇸
PPD Development, LP, Austin, Texas, United States
Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin XR Tablet (Manufactured in Mt Vernon, IN) Relative to 5 mg Saxagliptin Tablet and 500 mg Metformin XR Tablet (Manufactured in Evansville, IN)
- Conditions
- Interventions
- First Posted Date
- 2010-08-31
- Last Posted Date
- 2015-05-21
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 30
- Registration Number
- NCT01192139
- Locations
- 🇺🇸
Ppd Development, Lp, Austin, Texas, United States
Drug Development Updates
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