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

Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus

Phase 3

Completed

Conditions: Diabetes Type 2

Interventions: Drug: Exenatide once weekly suspension
Drug: Sitagliptin
Drug: Placebo

First Posted Date: 2012-07-30

Last Posted Date: 2015-08-20

Lead Sponsor: AstraZeneca

Target Recruit Count: 365

Registration Number: NCT01652729

Locations: 🇺🇸
Research Site, Spokane, Washington, United States
🇺🇸
Reseach Site, Rapid City, South Dakota, United States

Treatment With Sitagliptin in Non-obese Japanese Patients With Type 2 Diabetes Mellitus

Not Applicable

Conditions: Type 2 Diabetes

Interventions: Drug: Sitagliptin

First Posted Date: 2012-07-17

Last Posted Date: 2012-08-21

Lead Sponsor: Niigata Medical Center

Target Recruit Count: 40

Registration Number: NCT01642108

Locations: 🇯🇵
Nobumasa Ohara, Niigata, Japan

Clinical Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LEZ763

Phase 1

Completed

Conditions: Type II Diabetes

Interventions: Drug: Placebo
Drug: LEZ763
Drug: Sitagliptin

First Posted Date: 2012-06-14

Last Posted Date: 2020-12-17

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 220

Registration Number: NCT01619332

Locations: 🇺🇸
Novartis Investigative Site, San Antonio, Texas, United States

Contribution of Pancreatic αcells Function to Blood Glucose Regulation in Chinese Type 2 Diabetics- the Effect of Sitagliptin on Glucagon Secretion, Insulin Secretion and Insulin Resistance in Chinese Type 2 Diabetics

Phase 4

Completed

Conditions: Insulin Secretion
Insulin Resistance

Interventions: Drug: Sitagliptin

First Posted Date: 2012-06-01

Last Posted Date: 2017-05-11

Lead Sponsor: Guangwei Li

Target Recruit Count: 85

Registration Number: NCT01610154

Locations: 🇨🇳
Fuwai Hospital, Beijing, China

Sitagliptin Regulation of Intestinal and Hepatic Lipoprotein Particle and Hepatic Glucose Production in Humans

Phase 2

Completed

Conditions: Hyperlipidemia

Interventions: Drug: Placebo
Drug: Sitagliptin

First Posted Date: 2012-05-17

Last Posted Date: 2017-01-23

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 21

Registration Number: NCT01600703

Locations: 🇨🇦
Toronto General Hospital, Toronto, Ontario, Canada

A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Insulin With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-254)

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Placebo
Drug: Sitagliptin
Biological: Insulin
Drug: Metformin

First Posted Date: 2012-05-03

Last Posted Date: 2018-08-17

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 467

Registration Number: NCT01590797

A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Sulfonylurea With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-253)

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Placebo
Drug: Sitagliptin
Drug: Gliclazide
Drug: Glimepiride
Drug: Metformin

First Posted Date: 2012-05-03

Last Posted Date: 2018-08-17

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 498

Registration Number: NCT01590771

DPP-IV Inhibitors Underlying Mechanism of Cancer in Diabetic Patients

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Sitagliptin
Drug: Alogliptin
Drug: Vildagliptin

First Posted Date: 2012-05-01

Last Posted Date: 2012-10-19

Lead Sponsor: Nagaoka Red Cross Hospital

Target Recruit Count: 500

Registration Number: NCT01588587

Locations: 🇯🇵
Kurume University, Kurume, Fukuoka, Japan
🇯🇵
Nagaoka Red Cross Hospital, Nagaoka, Niigata, Japan

A Pilot Study Evaluating Safety of Sitagliptin Combined With Peg-IFN Alfa-2a + Ribavirin in Chronic Hepatitis C Patients

Phase 1

Terminated

Conditions: Hepatitis C

Interventions: Drug: Sitagliptin

First Posted Date: 2012-03-30

Last Posted Date: 2014-01-20

Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Target Recruit Count: 3

Registration Number: NCT01567540

Locations: 🇫🇷
Centre Hospitalier Victor Dupuy, Argenteuil, France
🇫🇷
Henri Mondor Hospital, Créteil, France
🇫🇷
Centre Hospitalier Intercommunal Créteil, Créteil, France

and more 1 locations

Effectiveness of Sitagliptin for HIV Insulin Resistance and Inflammation

Phase 3

Completed

Conditions: Inflammation
Cardiovascular Disease
Macrophage Infiltration

Interventions: Drug: Placebo
Drug: Sitagliptin

First Posted Date: 2012-03-13

Last Posted Date: 2018-05-08

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 38

Registration Number: NCT01552694

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

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