Sitagliptin

Generic Name: Sitagliptin

Brand Names: Janumet, Januvia, Ristaben, Steglujan, Tesavel, Velmetia, Xelevia, Sitagliptin SUN, Sitagliptin Accord

Drug Type: Small Molecule

Chemical Formula: C_₁₆H_₁₅F_₆N_₅O

CAS Number: 486460-32-6

Unique Ingredient Identifier: QFP0P1DV7Z

Background: Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used in conjunction with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. The effect of this medication leads to glucose dependent increases in insulin and decreases in glucagon to improve control of blood sugar. Sitagliptin was granted FDA approval on October 16, 2006.

Indication: Sitagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is not used to treat type 1 diabetes or patients with a history of pancreatitis.

It is also used in combination with metformin or ertugliflozin.

Associated Conditions: Type 2 Diabetes Mellitus

Associated Therapies: -

Clinical Trials

A Study to Characterize the Effect on the Pharmacokinetics of ASP1941 and Sitagliptin When Given Together to Healthy Subjects

Phase 1

Completed

Conditions: Healthy
Pharmacokinetics of ASP1941

Interventions: Drug: ASP1941
Drug: sitagliptin

First Posted Date: 2010-04-15

Last Posted Date: 2010-04-16

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 64

Registration Number: NCT01104532

Sitagliptin Versus Insulin Dose Increase in Type 2 Diabetes on Insulin Treatment

Phase 4

Completed

Conditions: Diabetes

Interventions: Drug: insulin dose increase
Drug: sitagliptin

First Posted Date: 2010-04-08

Last Posted Date: 2013-10-25

Lead Sponsor: Seoul National University Bundang Hospital

Target Recruit Count: 140

Registration Number: NCT01100125

Locations: 🇰🇷
Seoul National University Bundang Hospital, Seongnam, Korea, Republic of

Ketosis-Prone Diabetes Mellitus (KPDM): Metformin Versus Sitagliptin Treatment

Phase 4

Completed

Conditions: Diabetes Ketoacidosis
Hyperglycemia
Ketosis Prone Diabetes

Interventions: Drug: placebo
Drug: metformin
Drug: Sitagliptin

First Posted Date: 2010-04-07

Last Posted Date: 2015-06-18

Lead Sponsor: Dawn Smiley MD

Target Recruit Count: 48

Registration Number: NCT01099618

Locations: 🇺🇸
Grady Memorial Hospital, Atlanta, Georgia, United States

A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Biological: albiglutide
Drug: sitagliptin

First Posted Date: 2010-04-02

Last Posted Date: 2017-02-28

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 507

Registration Number: NCT01098539

Locations: 🇬🇧
GSK Investigational Site, Swansea, United Kingdom

Vascular Effects of Sitagliptin in Diabetes Mellitus

Phase 4

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Placebo
Other: Control
Drug: Sitagliptin

First Posted Date: 2010-03-31

Last Posted Date: 2010-03-31

Lead Sponsor: Hannover Medical School

Target Recruit Count: 70

Registration Number: NCT01096277

Locations: 🇩🇪
Hannover Medical School, Hannover, Germany

Investigate the Effect of AZD1656 on the Pharmacokinetics of Sitagliptin in Patients With Type 2 Diabetes Mellitus

Phase 1

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: AZD1656
Drug: Sitagliptin

First Posted Date: 2010-03-30

Last Posted Date: 2010-07-01

Lead Sponsor: AstraZeneca

Target Recruit Count: 12

Registration Number: NCT01095991

Locations: 🇩🇪
Research Site, Neuss, Germany

Dipeptidyl Peptidase-4 Inhibition and Immune Function in HIV

Phase 2

Completed

Conditions: Diabetes
Insulin Resistance

Interventions: Drug: Placebo
Drug: Sitagliptin

First Posted Date: 2010-03-26

Last Posted Date: 2014-02-17

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 20

Registration Number: NCT01093651

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

The Effects of Co-admin of Colesevelam and Sitagliptin on Glucose Metabolism in Subjects With Type 2 Diabetes Mellitus

Not Applicable

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Colesevelam HCl
Drug: Sitagliptin

First Posted Date: 2010-03-25

Last Posted Date: 2013-01-17

Lead Sponsor: KineMed

Target Recruit Count: 61

Registration Number: NCT01092663

Locations: 🇺🇸
Healthcare Discoveries, LLC d/b/a ICON Development Solutions, San Antonio, Texas, United States
🇺🇸
University of California, San Francisco, San Francisco, California, United States
🇺🇸
Clinical Pharmacology of Miami, Miami, Florida, United States

Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus Receiving Background Treatment With Glimepiride Alone or in Combination With Metformin or With Pioglitazone Alone

Phase 3

Terminated

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Sitagliptin
Drug: Dutogliptin

First Posted Date: 2010-03-19

Last Posted Date: 2011-09-21

Lead Sponsor: Forest Laboratories

Target Recruit Count: 141

Registration Number: NCT01089790

Locations: 🇺🇸
Forest Investigative Site 061, Anaheim, California, United States
🇺🇸
Forest Investigative Site 129, Hollywood, Florida, United States
🇺🇸
Forest Investigative Site 156, Boca Raton, Florida, United States

and more 146 locations

The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Placebo
Drug: Canagliflozin
Drug: Sitagliptin

First Posted Date: 2010-03-05

Last Posted Date: 2017-02-23

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 678

Registration Number: NCT01081834

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy