Drugs / Sitagliptin
Sitagliptin
also known as
Sitagliptin phosphate · Januvia · MK-0431 · sita · JanuviaTM · MK-0431/ONO-5435 · - sitagliptine (Januvia) · Januvia (brand name for sitagliptin) · +6 more
Small molecule targets DPP4 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (5) | US (FDA) | JANUVIA | — | 2007-10-12 – 2020-12-04 | fda.gov ↗ |
| Rejected (CRL) | US (FDA) | JANUVIA, JANUMET, JANUMET XR | — | 2017-04-07 | “issued a Complete Response Letter regarding Merck’s Supplemental New Drug Applications for JANUVIA ® (sitagliptin)” merck.com ↗ |
| Refused (EMA) | EU (EMA) | Janumet | — | 2009-02-18 | europa.eu ↗ |
| Approved | EU (EMA) | Januvia | — | 2007-03-20 | europa.eu ↗ |
| Approved | US (FDA) | JANUVIA | — | 2006-10-16 | fda.gov ↗ |
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News releases announcing trial results or a regulatory action · 52
| Date | Issuer | Release |
|---|---|---|
| 2025-06-23 | Hua Medicine Limited | Results [News] Hua Medicine Announces at 2025 ADA Scientific Sessions that Dorzagliatin Combined with DPP-4 Inhibitor Shows Promise in Reducing Blood Lipids While Restoring Glucose Homeostasis huamedicine.com ↗
A preclinical animal study showed that the combination of dorzagliatin and sitagliptin, a DPP-4 inhibitor, improves blood glucose levels, promotes insulin secretion, and enhances GLP-1 secretion. |
| 2025-06-18 | Hua Medicine Limited | Results [News] Hua Medicine Will Present Research Results and Be Invited to Broadcast Series of TV Reports at the 2025 American Diabetes Association (ADA) Scientific Sessions huamedicine.com ↗
The animal research shows that the combination of dorzagliatin with the DPP-4 inhibitor sitagliptin can improve blood glucose levels, increase insulin secretion, and enhance GLP-1 secretion. |
| 2024-11-28 | Lupin Limited | Regulatory Lupin Receives Tentative Approval from U.S. FDA for Sitagliptin and Metformin Hydrochloride Tablets lupin.com ↗ |
| 2023-12-15 | Lupin Limited | Regulatory Lupin Receives Tentative Approval from U.S. FDA for Sitagliptin Tablets lupin.com ↗ |
| 2021-10-11 | Zentiva, k.s. | Results Zent2U announces successful Pivotal BE trial on Sitagliptin development zentiva.com ↗
The study was performed under fasting conditions between our product Sitagliptin film-coated tablets (Zentiva) and the European reference product Januvia ® (MSD) and our endpoints perfectly matched the bioequivalence parameters. |
| 2021-09-06 | Zydus Lifesciences Limited | Regulatory Zydus Cadilas Sitagliptin Base Tablets Receives Tentative Approval from FDA zyduslife.com ↗
Zydus Cadila today announced that its subsidiary has received tentative approval from the United States Food and Drug Administration (FDA) for its new drug application for Sitagliptin base 25, 50 and 100 mg tablets. |
| 2021-05-31 | Hua Medicine Limited | Results Hua Medicine to present additional dorzagliatin data at ADA 2021 huamedicine.com ↗
Dorzagliatin administered in combination with sitagliptin can regulate GLP-1 release in T2D patients. |
| 2020-01-06 | Hua Medicine Limited | Results Hua Medicine Announces Positive Results of HMM0110 and HMM0111 huamedicine.com ↗
Co-administration orally of dorzagliatin and sitagliptin at steady state demonstrated no impact on their PK properties but, following OGTT, based on glucose AUEC, the combined effect (AUEC: 253 h*mg/dL) is superior to sitagl |
| 2019-03-14 | Zydus Lifesciences Limited | Regulatory Zydus receives tentative approval from the USFDA for Sitagliptin and Metformin Hydrochloride Extended-Release Tablets zyduslife.com ↗
Zydus Cadila has received the tentative approval from the USFDA to market Sitagliptin and Metformin Hydrochloride Extended- Release Tablets, (US RLD – JANUMET® XR), 50 mg/500 mg, 50 mg/1,000 mg and 100 mg/1,000 mg. |
| 2018-09-11 | Zydus Lifesciences Limited | Regulatory Zydus receives tentative approval from the USFDA for Sitagliptin Tablets zyduslife.com ↗
Zydus Cadila has received the tentative approval from the USFDA for Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg (US RLD –Januvia ® Tablets). |
| 2018-06-28 | Novo Nordisk A/S | Results Oral semaglutid viser større reduktioner i langtidsblodsukker og vægt end sitagliptin i langtidsstudie af sikkerhed og effekt (PIONEER 3) novonordisk.com ↗
Studiet opfyldte sit primære mål vurderet ud fra den primære statistiske metode, idet det viste statistisk signifikante og større forbedringer i langtidsblodsukkeret (HbA1c) ved behandling med 7 og 14 mg oral semaglutid sammenlignet med sitagliptin ved uge 26. |
| 2018-06-28 | Novo Nordisk A/S | Results Oral semaglutide shows superior reductions in HbA1c and weight compared to sitagliptin in the long-term safety and efficacy trial, PIONEER 3 novonordisk.com ↗
The trial achieved its primary objective according to the primary statistical approach by demonstrating statistically significant and superior reductions in HbA1c with oral semaglutide 7 and 14 mg compared to sitagliptin at week 26. |
| 2018-06-23 | Merck Sharp & Dohme LLC | Results Merck Presents New Data from the Comparative Trials with Sitagliptin (CompoSIT) Clinical Trial Program with JANUVIA® (sitagliptin) merck.com ↗
In the CompoSIT-I study, initiation of insulin therapy while continuing treatment with JANUVIA resulted in greater blood glucose reductions and more patients reaching A1C goal compared to those who discontinued JANUVIA. |
| 2018-06-20 | Novo Nordisk A/S | Results Oral semaglutid viser statistisk signifikant større reduktioner i langtidsblodsukker og vægt sammenlignet med Victoza® og sitagliptin i PIONEER 4 og 7 novonordisk.com ↗ |
| 2018-06-20 | Novo Nordisk A/S | Results Oral semaglutide shows statistically significantly greater reductions in HbA1c and weight compared to Victoza® and sitagliptin in the PIONEER 4 and 7 trials novonordisk.com ↗ |
| 2017-12-22 | Pfizer | Regulatory FDA Approves SGLT2 Inhibitor STEGLATRO™ (ertugliflozin) and Fixed-Dose Combination STEGLUJAN™ (ertugliflozin and sitagliptin) for Adults with Type 2 Diabetes pfizer.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Pfizer Inc. (NYSE:PFE), today announced that the U.S. Food and Drug Administration (FDA) has approved STEGLATRO™ (ertugliflozin) tablets, an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, and the fixed-dose combination STEGLUJAN™ (ertugliflozin and sitagliptin) tablets. |
| 2017-12-22 | Merck Sharp & Dohme LLC | Regulatory FDA Approves SGLT2 Inhibitor STEGLATRO™ (ertugliflozin) and Fixed-Dose Combination STEGLUJAN™ (ertugliflozin and sitagliptin) for Adults with Type 2 Diabetes merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Pfizer Inc. (NYSE:PFE), today announced that the U.S. Food and Drug Administration (FDA) has approved STEGLATRO TM (ertugliflozin) tablets, an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, and the fixed-dose combination STEGLUJAN™ (ertugliflozin and sitagliptin) tablets. |
| 2017-06-10 | Merck Sharp & Dohme LLC | Results Merck and Pfizer Announce That Investigational SGLT-2 Inhibitor Ertugliflozin Met Primary Endpoint in Two Phase 3 Studies merck.com ↗
both doses of ertugliflozin tested (5 mg and 15 mg daily) achieved statistically significant reductions in A1C, a measure of average blood glucose over a two- to three-month timeframe, when added to metformin or in initial co-administration with sitagliptin. |
| 2017-05-19 | Astellas Pharma Inc | Regulatory MSD submits application for approval of type-2 diabetes drug combining selective DPP-4 inhibitor and selective SGLT2 inhibitor astellas.com ↗
MSD submits application for approval of type-2 diabetes drug combining selective DPP-4 inhibitor and selective SGLT2 inhibitor |
| 2017-04-07 | Merck Sharp & Dohme LLC | Regulatory Merck Receives Complete Response Letter from the U.S. FDA for TECOS Study with Sitagliptin merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding Merck’s Supplemental New Drug Applications for JANUVIA ® (sitagliptin), JANUMET ® (sitagliptin and metformin HCl) and JANUMET XR ® (sitagliptin and metformin HCl extended-release). |
| 2017-03-06 | Pfizer | Regulatory Merck and Pfizer Announce U.S. FDA and EMA Filing Acceptances of Three Marketing Applications for Ertugliflozin-Containing Medicines for Adults with Type 2 Diabetes pfizer.com ↗
Additionally, the European Medicines Agency (EMA) has validated for review three Marketing Authorization Applications (MAAs) for ertugliflozin monotherapy and the two fixed-dose combination products. |
| 2017-03-06 | Merck Sharp & Dohme LLC | Regulatory Merck and Pfizer Announce U.S. FDA and EMA Filing Acceptances of Three Marketing Applications for Ertugliflozin-Containing Medicines for Adults with Type 2 Diabetes merck.com ↗
Additionally, the European Medicines Agency (EMA) has validated for review three Marketing Authorization Applications (MAAs) for ertugliflozin monotherapy and the two fixed-dose combination products. |
| 2016-06-11 | Pfizer | Results Merck and Pfizer Announce Two Pivotal Phase 3 Studies for Ertugliflozin, an Investigational SGLT-2 Inhibitor, Met Primary Endpoints, Showing Significant A1C Reductions in Patients with Type 2 Diabetes pfizer.com ↗
This study also met its primary endpoint, with greater reductions in A1C observed in patients taking ertugliflozin in combination with sitagliptin compared to ertugliflozin or sitagliptin alone. |
| 2016-06-11 | Merck Sharp & Dohme LLC | Results Merck and Pfizer Announce Two Pivotal Phase 3 Studies for Ertugliflozin, an Investigational SGLT-2 Inhibitor, Met Primary Endpoints, Showing Significant A1C Reductions in Patients with Type 2 Diabetes merck.com ↗
The study results showed statistically significant reductions in A1C (a measure of average blood glucose) for both ertugliflozin doses tested (5 mg and 15 mg daily). |
| 2016-03-14 | Janssen Research & Development, LLC | Results First Real-World Evidence Comparing an SGLT2 Inhibitor with DPP-4 Inhibitors Shows Adults with Type 2 Diabetes Achieve Greater Blood Glucose Control with INVOKANA® (canagliflozin) jnj.com ↗
Similar results were observed in a post-hoc analysis of those treated with INVOKANA versus the DPP-4 inhibitor, sitagliptin. |
| 2015-12-17 | Novo Nordisk A/S | Results Novo Nordisk afslutter med succes det fjerde fase 3a-studie med semaglutid til behandling af type 2-diabetes novonordisk.com ↗
sammenlignet med en forbedring i HbA1c på 0,5% med 100 mg sitagliptin. |
| 2015-09-16 | Merck Sharp & Dohme LLC | Results Merck’s Omarigliptin, an Investigational Once-Weekly DPP-4 Inhibitor, Achieved Similar A1C Reductions to JANUVIA® (sitagliptin) in Patients with Type 2 Diabetes Inadequately Controlled on Metformin Monotherapy merck.com ↗
Omarigliptin was found to be non-inferior to Merck’s once-daily DPP-4 inhibitor, JANUVIA ® (sitagliptin), at reducing patients’ A1C * levels from baseline, with similar A1C reductions achieved in both groups. |
| 2015-06-08 | Merck Sharp & Dohme LLC | Results TECOS, Merck’s Cardiovascular Safety Trial of JANUVIA (sitagliptin), Met Primary Endpoint in Patients with Type 2 Diabetes merck.com ↗
The study achieved its primary composite CV endpoint of non-inferiority (defined as the time to the first confirmed event of any of the following: CV-related death, nonfatal myocardial infarction (MI), nonfatal stroke, or hospitalization for unstable angina) compared to usual care without sitagliptin. |
| 2015-06-08 | AstraZeneca | Results New real-world data analysis finds no evidence of increased risk of hospitalisation for heart failure with saxagliptin compared with sitagliptin astrazeneca.com ↗
AstraZeneca today announced results from an observational, retrospective study which found no evidence of increased risk of hospitalisation for heart failure (hHF) with saxagliptin, compared with sitagliptin, both of which are dipeptidyl peptidase-4 (DPP-4) inhibitors, in patients with type 2 diabetes. |
| 2015-04-28 | Merck Sharp & Dohme LLC | Results Merck Announces First-Quarter 2015 Financial Results merck.com ↗
The company announced the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) of JANUVIA (sitagliptin), a medicine that helps lower blood sugar levels in adults with type 2 diabetes, achieved its primary endpoint of non-inferiority for the composite cardiovascular endpoint. |
| 2015-04-27 | Merck Sharp & Dohme LLC | Results Merck Announces the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) Met Primary Endpoint merck.com ↗
Among secondary endpoints, there was no increase in hospitalization for heart failure in the sitagliptin group versus placebo. |
| 2014-06-14 | Merck Sharp & Dohme LLC | Results New Post-Hoc Analysis Shows Patients with Type 2 Diabetes Undergoing Intensification of Insulin Therapy Experienced Less Nighttime Hypoglycemia While Being Treated with JANUVIA® (sitagliptin) Compared to Placebo merck.com ↗ |
| 2014-06-14 | Merck Sharp & Dohme LLC | Results Late-Breaking Observational Data Show Patients with Type 2 Diabetes Taking JANUVIA® (sitagliptin) and Metformin Initiated Insulin Therapy at a Slower Rate Compared to Patients Taking a Sulfonylurea and Metformin merck.com ↗
In this study, patients treated with a combination of JANUVIA and metformin initiated insulin therapy at a slower rate during the period of observation than patients treated with a combination of sulfonylurea and metformin. |
| 2014-06-06 | Merck Sharp & Dohme LLC | Results Merck to Present New Clinical Data on JANUVIA® (Sitagliptin), Investigational Omarigliptin, and Real-World Data in Patients with Type 2 Diabetes at the 74th Scientific Sessions of the American Diabetes Association merck.com ↗
Addition of Sitagliptin Improved Glycemic Control and Was Well Tolerated in Japanese Patients with Type 2 Diabetes on Glinides Monotherapy |
| 2013-07-26 | Merck Sharp & Dohme LLC | Regulatory Merck Statement Regarding CHMP Review of Incretin-Based Therapies for Type 2 Diabetes, Including Sitagliptin merck.com ↗
Investigation into GLP-1 based diabetes therapies concluded: No new concerns for GLP-1 therapies identified on the basis of available evidence. |
| 2013-06-24 | GlaxoSmithKline | Results GSK announces data from five Phase III studies of albiglutide, an investigational once-weekly treatment for type 2 diabetes gsk.com ↗
At Week 104, the reduction in HbA1c was statistically significant in the albiglutide group compared to those treated with placebo (-0.9%; p<0.0001), sitagliptin (-0.4%; p=0.0001), or glimepiride (-0.3%; p=0.003). |
| 2013-06-23 | Janssen Research & Development, LLC | Results Studies Reinforce INVOKANA™ (canagliflozin) (300mg) Provides Greater Improvements in Blood Glucose than Sitagliptin (100 mg) or Glimepiride (6 or 8 mg) in Adults with Type 2 Diabetes jnj.com ↗
The study also showed that 100 mg of INVOKANA™ provided similar improvements in blood glucose control to sitagliptin, and both doses of INVOKANA™ resulted in greater secondary endpoint reductions in body weight and blood pressure. |
| 2013-06-22 | Eli Lilly and Company | Results Phase III data show significant reductions in blood glucose with investigational compound empagliflozin used as monotherapy in adults with type 2 diabetes lilly.com ↗
Sitagliptin 100 mg (which was used as an active comparator to validate the trial design and not for a head-to-head comparison with empagliflozin) showed a reduction in HbA1c of 0.73 percent compared to placebo (p < 0.001). |
| 2012-07-11 | GlaxoSmithKline | Results GSK announces positive data from Harmony 8 and completion of clinical registration package for albiglutide in type 2 diabetes gsk.com ↗
At the 26-week primary endpoint, albiglutide showed clinically and statistically significant reductions in HbA1c from baseline (8.08% for albiglutide and 8.22% for sitagliptin)and superiority versus sitagliptin (reduction of 0.83% vs 0.52%; p |
| 2012-02-28 | Merck Sharp & Dohme LLC | Regulatory Merck Provides Information on FDA Post-Marketing Requirement for Sitagliptin merck.com ↗
However, FDA informed Merck that what Merck has submitted does not satisfy the post-marketing requirement, and directed Merck to conduct a new 3-month rodent study. |
| 2012-02-02 | Merck Sharp & Dohme LLC | Regulatory FDA Approves JANUMET® XR (sitagliptin and metformin HCl extended-release) for Type 2 Diabetes, Offering the Powerful Efficacy of JANUMET® (sitagliptin/metformin HCl) Now Available with Once-Daily Convenience merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved JANUMET ® XR (sitagliptin and metformin hydrochloride (HCl) extended-release) tablets, a new treatment for type 2 diabetes that combines sitagliptin, which is the active component of JANUVIA ® (sitagliptin), with extended-release metformin. |
| 2011-10-07 | Merck Sharp & Dohme LLC | Regulatory FDA Approves Merck’s JUVISYNC™ (sitagliptin and simvastatin) Tablets, a Once-Daily Therapy for Patients with Type 2 Diabetes Who Need to Lower Blood Sugar and Cholesterol, Known Risk Factors for Cardiovascular Disease merck.com ↗
The FDA approved JUVISYNC based upon clinical bioequivalence studies in healthy subjects that demonstrated administration of JUVISYNC is equivalent to co-administration of corresponding doses of the two individual medications, sitagliptin and simvastatin, as separate tablets. |
| 2011-09-13 | Alkermes, Inc. | Results Analyses Find Type 2 Diabetes Patients Treated with BYDUREON(TM) Experienced Reduction in Cardiovascular Risk Factors: Results Presented at EASD 2011 alkermes.com ↗
The post-hoc analyses showed patients treated with BYDUREON or metformin were more likely to achieve clinically relevant composite goals than patients treated with Actos or Januvia. |
| 2011-09-12 | Eli Lilly and Company | Results Analyses Find Type 2 Diabetes Patients Treated with BYDUREON™ Experienced Reduction in Cardiovascular Risk Factors: Results Presented at EASD 2011 lilly.com ↗
Achieved a composite endpoint of A1C 7 percent, no weight gain and no minor or major hypoglycemia (48 percent for BYDUREON vs. 22 percent for Actos, 35 percent for Januvia and 46 percent for metformin); |
| 2010-11-17 | Eli Lilly and Company | Results Study Highlights Incidence of Cardiovascular Disease-Related Events and All-Cause Hospitalizations Associated with BYETTA® Compared to Insulin, Thiazolidinediones, Sulfonylureas, Metformin and Januvia® lilly.com ↗
In the study, BYETTA was associated with a lower incidence of CVD-related events than insulin, thiazolidinediones (TZDs) and sulfonylureas and a comparable incidence versus metformin and Januvia® (sitagliptin). |
| 2010-06-26 | XOMA (US) LLC | Results Preclinical Results With XOMA 052 in Type 2 Diabetes Presented at American Diabetes Association 70th Scientific Sessions xoma.com ↗
The results also demonstrated no deleterious effects with the two-drug combinations and improved insulin tolerance with a combination of XOMA 052 and sitagliptin. |
| 2010-06-15 | Eli Lilly and Company | Results DURATION-4 Study Results: BYDUREON Efficacy and Tolerability Profile Extended to Monotherapy Treatment lilly.com ↗
After 26 weeks of treatment, patients randomized to BYDUREON experienced a reduction in A1C of 1.5 percentage points from baseline, which was significantly greater than the reduction of 1.2 percentage points for Januvia. |
| 2010-06-15 | Alkermes, Inc. | Results DURATION-4 Study Results: BYDUREON™ Efficacy and Tolerability Profile Extended to Monotherapy Treatment alkermes.com ↗
After 26 weeks of treatment, patients randomized to BYDUREON experienced a reduction in A1C of 1.5 percentage points from baseline, which was significantly greater than the reduction of 1.2 percentage points for Januvia. |
| 2009-10-05 | AstraZeneca | Results Study Finds That ONGLYZA (saxagliptin) When Added to Metformin was Non-Inferior to Januvia (sitagliptin) When Added to Metformin in Reducing Hemoglobin (HbA1c) in Adults with Type 2 Diabetes Mellitus astrazeneca.com ↗
In this study, overall adverse events were reported at a similar rate for individuals taking ONGLYZA 5 mg plus metformin and JANUVIA 100 mg plus metformin. |
| 2009-10-05 | Bristol-Myers Squibb | Results Study Finds That ONGLYZA™ (saxagliptin) When Added To Metformin Was Non-Inferior To JANUVIA (SITAGLIPTIN) When Added To Metformin In Reducing Hemoglobin (HbA1c) In Adults With Type 2 Diabetes Mellitus bms.com ↗
the addition of treatment with ONGLYZA ™ (saxagliptin) 5 mg per day achieved the primary objective of demonstrating non-inferiority compared to the addition of treatment with JANUVIA ® (sitagliptin) 100 mg per day in reducing HbA1c from baseline. |
| 2009-03-31 | Eli Lilly and Company | Results Exenatide Once Weekly Provided Superior Glucose Control With Weight Loss Compared to Sitagliptin or Pioglitazone in Head-to-Head DURATION-2 Study lilly.com ↗
Treatment with exenatide once weekly also produced statistically significant differences in weight, with weight loss of 6.2 pounds at 26 weeks, compared with a loss of 1.9 pounds for sitagliptin, and a weight gain of 7.4 pounds for pioglitazone. |
| 2008-09-09 | Eli Lilly and Company | Results First Reported Head-to-Head Study Showed BYETTA(R) (exenatide) Injection Provided Greater Reduction in Post-Meal Glucose Levels Than Januvia(TM) (sitagliptin) in Patients With Type 2 Diabetes lilly.com ↗
Additionally, patients treated with BYETTA reduced post-meal glucagon, showed more efficient use of their body's own insulin and decreased their food intake when compared to Januvia. |
All press releases naming this drug 70 releases
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 479 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | sitagliptin | “Subjects will be randomized 1:1 to open-label eucaloric very-low carbohydrate ketogenic diet (<40 g of carbohydrate) or standard of care (i.e. metformin, followed by...” NCT07866846 ↗466“We included 12 patients with type 2 diabetes (mean ± SD BMI 27 ± 2.6 kg/m2, HbA1c 7.1 ± 1.4% [54 ± 15 mmol/mol]) in this double-blind, placebo-controlled, crossover study to...” PMID 35796651 ↗ Oct 2022 “The aim of the present study was to determine whether sitagliptin combined with metformin as an initial treatment had non-inferior outcomes with regards to glycaemic remission...” PMID 33574913 ↗ Jan 2021 “Sitagliptin is an orally active, potent and highly selective DPP-4 inhibitor which was approved by the U.S. Food and Drug Administration (FDA) in October 2006 as a new class of...” NCT01269996 ↗ “DPP-4 inhibitor (sitagliptin, vildagliptin, alogliptin, linagliptin, teneligliptin, anagliptin or saxagliptin) will be suspended for one month and serum BNP will be measured.” NCT02312427 ↗ “An Assessment of Pharmacokinetic Interaction Between Lobeglitazone and Sitagliptin After Multiple Oral Administrations in Healthy Men.” PMID 32362346 ↗ Apr 2020 “Chemical Names: Sitagliptin, Vildagliptin, Saxagliptin, Linagliptin, Alogliptin Class: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors” NCT06449235 ↗ “two fixed-dose combinations (FDCs) of sitagliptin 100 mg with empagliflozin 10 mg (DW1026C1) or empagliflozin 25 mg (DW1026C2)” PMID 41883295 ↗ Mar 2026 “MK0431 (Sitagliptin) and Metformin Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-036)” NCT00103857 ↗ “Drug: Dapagliflozin and Sitagliptin Single oral administration of Dapagliflozin and Sitagliptin after an overnight fast” NCT05403281 ↗ “Sitagliptin did not change fractional lithium excretion but significantly increased total fractional sodium excretion” PMID 28550195 ↗ May 2017 |
| Known as | - sitagliptine (Januvia) | “- sitagliptine (Januvia®)” NCT02244164 ↗ |
| Known as | Januvia | “Part A is a double-blind, randomized, parallel group, dose-ranging study, in subjects with type 2 diabetes mellitus to assess safety, tolerability, and to estimate the...” NCT00976261 ↗14“To compare the efficacy of three strategies of lifestyle changes associated with Januvia (sitagliptin) 100 mg/day in patients with Type 2 Diabetes Mellitus (T2DM) inadequately...” NCT00545584 ↗ “This study tests whether a medicine in this class called sitagliptin (Januvia), which is commonly used to treat T2DM, affects markers of bone turnover in patients with T2DM.” NCT00732121 ↗ “After inclusion in the study to J0, metformin treatment will be interrupted between J1 and J30, replaced by Januvia 100 mg/day dose, then resumed at J31.” NCT01349387 ↗ “Januvia (sitagliptin phosphate 100mg) is an FDA approved medication for the treatment of Type 2 Diabetes.” NCT01512797 ↗ “Subjects are required to take oral 100mg Sitagliptin (Januvia) daily before breakfast for 12 weeks.” NCT03659461 ↗ “1 tablet of Forxiga® 10mg, 1 tablet of Januvia® 100mg and 1 tablet of Glifage XR® 1000mg” NCT06560333 ↗ “Active substance: Sitagliptin Januvia™ 100 mg once daily orally during three months” NCT00627744 ↗ “metformin+sitagliptin (Januvia)+lobeglitazone (Duvie)” NCT02188186 ↗ “Sitagliptin (Januvia)” NCT07439536 ↗ “Sitagliptin (Januvia)” NCT00813228 ↗ |
| Known as | Januvia (brand name for sitagliptin) | “Januvia (brand name for sitagliptin)” NCT00732121 ↗ |
| Known as | Januvia (sitagliptin) | “Januvia (sitagliptin)” NCT01951339 ↗ |
| Known as | Januvia (sitaglitin) | “Januvia (sitaglitin)” NCT01006018 ↗ |
| Known as | JanuviaTM | “sitagliptin (JanuviaTM) as add-on therapy to metformin” NCT00749190 ↗1“JanuviaTM (Sitagliptin)” NCT00484419 ↗ |
| Known as | MK-0431 | “A Randomized, Placebo-Controlled, 4-period, Crossover Study to Assess the Impact of MK-0431 (Sitagliptin) on Incretin Effect and the Role of Specific Incretin Hormones in...” NCT00551590 ↗7“The current study was initiated to define the effects of the DPP-IV inhibitor sitagliptin (MK0431) on transplanted islet survival in nonobese diabetic (NOD) mice, an autoimmune...” PMID 19073764 ↗ Dec 2008 “A Study of the Effects of Sitagliptin (MK0431) and Metformin on Incretin Hormone Concentrations (0431-050)(COMPLETED)” NCT00975052 ↗ “MK0431, sitagliptin phosphate / Duration of Treatment: 12 Weeks” NCT00371007 ↗ “MK0431, sitagliptin phosphate / Duration of Treatment: 21 Weeks” NCT00482079 ↗ “MK0431, sitagliptin phosphate / Duration of Treatment : 1 Days” NCT00418366 ↗ “Sitaglipin (MK-0431), 25 mg, once daily for 12 weeks, orally.” NCT00481663 ↗ |
| Known as | MK-0431/ONO-5435 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00854035 ↗ |
| Known as | sita | “The aim of this trial was to evaluate the efficacy and safety of the combination of once-daily insulin detemir (IDet) and sitagliptin (SITA) versus SITA ± sulphonylurea (SU),...” PMID 21205123 ↗ Mar 20113“This post hoc analysis compared the effects of 2 GLP-1 receptor- based therapies, exenatide once weekly (EQW), a GLP-1 receptor agonist, and sitagliptin (sita), a dipeptidyl...” PMID 23748507 ↗ May 2013 “SITA at a daily oral dose of 100 mg. The participants randomized to this group will receive 1 tablet daily of SITA 100 mg + 1 tablet of EVO placebo for 12 weeks.” NCT02689362 ↗ “adjunctive therapy of exenatide (EXE) (5-10 microg b.i.d.) or sitagliptin (SITA)” PMID 20357372 ↗ Mar 2010 |
| Known as | Sitagliptin phosphate | “This study compares the efficacy and safety of sitagliptin phosphate combined with gliclazide sustained-release tablets versus metformin in treatment-naïve patients with type 2...” NCT06613750 ↗18“Sitagliptin phosphate plus metformin hydrochloride combination tablet (MK-0431A) orally up to 50/1000 mg BID for 30 weeks” NCT00993187 ↗ “Januvia (sitagliptin phosphate 100mg) is an FDA approved medication for the treatment of Type 2 Diabetes.” NCT01512797 ↗ “MK0431, sitagliptin phosphate / Duration of Treatment: 12 Weeks” NCT00371007 ↗ “MK0431, sitagliptin phosphate / Duration of Treatment: 21 Weeks” NCT00482079 ↗ “MK0431, sitagliptin phosphate / Duration of Treatment : 1 Days” NCT00418366 ↗ “Comparator: sitagliptin phosphate (sitagliptin)” NCT00541450 ↗ “Drug: Sitagliptin phosphate” NCT01131182 ↗ “Drug: Sitagliptin phosphate” NCT01034111 ↗ “Drug: sitagliptin phosphate” NCT00484419 ↗ “Drug: Sitagliptin Phosphate” NCT00795275 ↗ |
| Known as | Sitagliptin phosphate (Januvia; Merck) | “Sitagliptin phosphate (Januvia; Merck)” NCT02900417 ↗ |
| Known as | sitagliptin, Januvia | “sitagliptin, Januvia” NCT01686932 ↗ |
| Known as | sitagliptine | “- sitagliptine (Januvia®)” NCT02244164 ↗ |
| Known as | STG | “One of the currently used anti-diabetic drugs that enhances GLP-1 availability is Sitagliptin (STG).” NCT02294084 ↗ |
| Action | Inhibit | “DPP-4 inhibitor sitagliptin 100 mg/day” PMID 25633134 ↗ Jan 2015 |
| Modality | Small molecule | “a new class of anti-diabetes compounds (DPPIV-inhibitors)” NCT01093651 ↗ |
| Route | Oral | “oral tablets of sitagliptin 100 mg” NCT00086515 ↗ |
| Target | DPP4 | “prevention of hormone degradation through DPP-IV inhibition” NCT00411411 ↗ |