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

Pharmacokinetics Study of Dipeptidyl Peptidase 4 Inhibitor to Control Type 2 Diabetes Mellitus

Phase 4

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Sitagliptin

First Posted Date: 2011-10-10

Last Posted Date: 2015-12-14

Lead Sponsor: The Catholic University of Korea

Target Recruit Count: 24

Registration Number: NCT01449747

Locations: 🇰🇷
The Catholic University of Korea; St.Paul's Hospital, Seoul, Korea, Republic of
🇰🇷
The Catholic University of Korea; Seoul St. Mary's Hospital, Seoul, Korea, Republic of

Pharmacodynamics of Mitiglinide/Sitagliptin Compared to Mitiglinide and Sitagliptin

Phase 1

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Sitagliptin
Drug: Mitiglinide
Drug: Sitagliptin, Mitiglinide

First Posted Date: 2011-08-24

Last Posted Date: 2011-09-07

Lead Sponsor: Samsung Medical Center

Target Recruit Count: 26

Registration Number: NCT01422590

Locations: 🇰🇷
Samsung Medical Center, Seoul, Korea, Republic of

Efficacy and Safety of TAK-875 in Combination With Sitagliptin in Participants With Type 2 Diabetes Mellitus

Phase 2

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: TAK-875 and Sitagliptin
Drug: Placebo
Drug: TAK-875
Drug: Sitagliptin

First Posted Date: 2011-08-11

Last Posted Date: 2016-04-04

Lead Sponsor: Takeda

Target Recruit Count: 368

Registration Number: NCT01414920

A Study of LY2189265 and Sitagliptin in Participants With Type 2 Diabetes

Phase 1

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Biological: LY2189265
Drug: Sitagliptin

First Posted Date: 2011-08-03

Last Posted Date: 2014-10-07

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 29

Registration Number: NCT01408888

Locations: 🇺🇸
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Dallas, Texas, United States

Vildagliptin Versus Sitagliptin - Differences in Fasting Plasma Glucose Lowering Efficacy

Phase 4

Completed

Conditions: Diabetes Mellitus Type 2

Interventions: Drug: Vildagliptin
Drug: Sitagliptin

First Posted Date: 2011-07-20

Last Posted Date: 2013-02-12

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 187

Registration Number: NCT01398592

Locations: 🇩🇪
Novartis Investigative Site, Stuttgart, Germany

Dipeptidyl Peptidase-4 Inhibitor (Sitagliptin) Therapy in the Inpatients With Type 2 Diabetes

Phase 4

Completed

Conditions: Type 2 Diabetes Mellitus
Hyperglycemia
Hospitalization

Interventions: Drug: glargine
Drug: lispro
Drug: Sitagliptin

First Posted Date: 2011-06-22

Last Posted Date: 2018-12-07

Lead Sponsor: Emory University

Target Recruit Count: 90

Registration Number: NCT01378117

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

Changes in Bone Turnover With Increased Incretin Hormone Exposure

Phase 4

Terminated

Conditions: Type 2 Diabetes Mellitus

Interventions: Other: Placebo
Drug: sitagliptin

First Posted Date: 2011-06-16

Last Posted Date: 2017-07-24

Lead Sponsor: University of Alabama at Birmingham

Target Recruit Count: 6

Registration Number: NCT01374568

Locations: 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States

An Observational Study of Type II Diabetics Treated With Dual Therapy With or Without Sitagliptin (Januvia®/Xelevia®, MK-0431-201)

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Antihyperglycemic Medication
Drug: Metformin
Drug: Sulfonylurea
Drug: Sitagliptin

First Posted Date: 2011-05-20

Last Posted Date: 2017-06-05

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 3453

Registration Number: NCT01357135

Effects of Sitagliptin on Type 2 Diabetes Mellitus Patients on Treatment With Metformin and Insulin

Phase 4

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Sitagliptin
Drug: Glimepiride
Drug: Metformin
Drug: Insulin

First Posted Date: 2011-04-26

Last Posted Date: 2014-05-30

Lead Sponsor: Jothydev's Diabetes and Research Centre

Target Recruit Count: 440

Registration Number: NCT01341717

Locations: 🇮🇳
Jothydev's Diabetes and Research Center, Thiruvananthapuram, Kerala, India

Study to Compare Sitagliptin Versus Sulfonylurea Treatment During Ramadan Fasting in Patients With Type 2 Diabetes (MK-0431-262)

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Sitagliptin
Drug: Sulfonylurea
Drug: Metformin

First Posted Date: 2011-04-25

Last Posted Date: 2017-06-05

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 870

Registration Number: NCT01340768

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