Janumet (metformin/sitagliptin) / Merck (MSD) - LARVOL DELTA

Factors Responsible for Successful Value-Based Agreements and Barriers for Their Adoption in the United States (ISPOR 2025) - "For instance, REPATHA ® ’s agreement linked payments to its ability to reduce LDL cholesterol, balancing patient benefits with payer costs. 2) Patient-centric approach: Successful agreements, like those for JANUVIA ® and JANUMET ® , incorporated both clinical outcomes and quality of life improvements. 3) Innovative payment models: LUXTURNA ® ’s pay-overtime model spread payments based on continued effectiveness, reducing financial risk... VBAs are increasingly enhancing access to innovative medications while ensuring cost-effectiveness. Overcoming adoption barriers requires multifaceted strategies and long-term planning, such as fostering stakeholder alignment and enhancing data collection and analytics capabilities."

Durability of glycemic response with FDC of sitagliptin and metformin in treatment naive T2DM Indian patients from a real-world retrospective EMR based study (ESPE-ESE 2025) - "This subgroup analysis of EMR based study in India demonstrated effectiveness of sitagliptin and metformin FDC, in significantly improving HbA1c and providing durable control over 9 months in treatment- naïve T2DM patients in a real-world setting with more proportion of patients achieving HbA1c <7% over time."

Real-world • Real-world evidence • Retrospective data • Type 2 Diabetes Mellitus

The effect of empagliflozin and sitagliptin as an add-on therapy to metformin in blood pressure reduction in diabetic patients in primary health care settings in Riyadh, Saudi Arabia. (PubMed, J Family Med Prim Care) - "Patients had a confirmed diagnosis of T2DM, were prescribed either Janumet or Synjardy, and had at least one BP reading within 3 months before and 2-24 weeks after starting treatment. Although neither drug significantly impacted BP, both combinations reduced HbA1c. Further research with a larger sample is needed to clarify their effects on BP."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Optimization and Validation of the UPLC Method for Rapid, Facile, and Simultaneous Analysis of Sitagliptin and Metformin in Quality Control Samples. (PubMed, ACS Omega) - "SG and MF were separated in a short time run of 2 min. The process was reliable in separating and extracting the drugs from the marketed Janumet tablets at a retention time of 0.73 and 1.36 min for SG and MF, respectively."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Brand prescription drugs to rise an average 4.5% in 2025 (SeekingAlpha) - "Pfizer...is increasing the price of more than 60 drugs, including its COVID-19 antiviral Paxlovid...and Xeljanz (tofacitinib) are going up in price between 3% and 5%....Merck (NYSE:MRK) is cutting the prices of two of its diabetes drugs, Januvia (sitagliptin) and Janumet (sitagliptin/metformin)."

Commercial • Ankylosing Spondylitis • Novel Coronavirus Disease • Psoriatic Arthritis • Rheumatoid Arthritis • Type 2 Diabetes Mellitus • Ulcerative Colitis

Peanut Induced Myositis: The Adversity from Overconsumption of Omega 6 Fatty Acids (AHA 2024) - "His home medications were aspirin, low-dose Crestor, Pioglitazone, Janumet, and Farxiga. The patient was educated on the detrimental health effects from over consumption of omega 6 fatty acids and the importance of moderation in the diet. This case illustrates the link between omega-6 fatty acid as a precursor to inflammatory disease. The patient's peanut consumption being the culprit of his myositis also highlights the importance of good history taking and exploring diet as a conduit to disease management."

Cardiovascular • Diabetes • Dyslipidemia • Hypertension • Immunology • Metabolic Disorders • Mood Disorders • Musculoskeletal Pain • Myocardial Infarction • Myositis • Pain • Type 2 Diabetes Mellitus

Suicidal attempt with sitagliptin and metformin overdose leading to severe metabolic acidosis: A case report (EUSEM 2024) - "Management includes aggressive fluid resuscitation, bicarbonate therapy to correct acidosis, and in severe cases, extracorporeal treatments such as hemodialysis to enhance metformin clearance.Case Presentation : A 21-year-old female with an unknown past medical illness, presented to the Emergency Department (ED) three hours after ingesting 60 tablets of Janumet 50/1000 mg (sitagliptin 50 mg and metformin 1000 mg) in a suicidal attempt...Metformin toxicity should be suspected in patients with a history of metformin ingestion who present with lactic acidosis, even if they are normoglycemic. Early recognition and prompt treatment, including IV fluid resuscitation, bicarbonate therapy, and hemodialysis, are essential for a favorable outcome in these patients.Learning Points : •Metformin toxicity can lead to severe metabolic acidosis and should be suspected in patients with a history of metformin ingestion who present with lactic acidosis, even if they are..."

Case report • Clinical • Cardiovascular • Diabetes • Hypoglycemia • Hypotension • Metabolic Disorders • Nephrology • Pain • Psychiatry • Type 2 Diabetes Mellitus

Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 50 mg /500 mg (FDC) in Healthy Adult Male and Female Subjects Under Fasting Conditions. (clinicaltrials.gov) - P1 | N=58 | Completed | Sponsor: Galenicum Health

New P1 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 50 mg /500 mg (FDC) in Healthy Adult Male and Female Subjects Under Fed Conditions. (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Galenicum Health

New P1 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg /1000 mg (FDC) in Healthy Adult Male and Female Subjects Under Fasting Conditions. (clinicaltrials.gov) - P1 | N=58 | Completed | Sponsor: Galenicum Health

New P1 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg /1000 mg (FDC) in Healthy Adult Male and Female Subjects Under Fed Conditions. (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Galenicum Health

New P1 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

metformin induced lactic acidosis in elderly patients (EUSEM 2023) - "metformin lactic acidosis is a rare complication and its formation is the result of a multifactorial process.we report the case of a 74-year-old patient, diabetic on metformin and janumet, hypertensionand heart rhythm disorder on antiarrhythmic; anticoagulant and beta-blocker.consulting the emergency room for deterioration of general condition for a month with diarrhea.arrived at the emergency room, the patient was conscious, polypneic with normal pulmonary ausculation and normal pulsed oxygen saturation,good hemodynamic constants contrasting with cyanosis of the extremities and HR at 60 bpm.Initial ECG showed bifascicular block at 60 (ECG1). afterwords ,the patient presented a bradycardia at 30 with wide QRS (ECG 2), we had time to take a blood gas which showed deep acidosis at 7.08with lactates at 8.4, hyperkalemia at 7.5 bicarbonates at 7 and hypocapnia at 26.while waiting for the results of the rest of the biology, a hyperkalemia corection protocol has been initiated..."

Clinical • Acute Kidney Injury • Anemia • Cardiovascular • Diabetic Nephropathy • Hematological Disorders • Hypertension • Metabolic Disorders • Renal Disease

Hyperglycemic DKA in Patient on Monotherapy with SGLT-2 Inhibitor (ENDO 2023) - "He was previously on Janumet 50-1000mg twice a day and changed to only dapagliflozin 10mg 9 months prior to the current episode. Monotherapy of SGLT-2 inhibitors appears to not only have a risk of euglycemic diabetic ketoacidosis but also a risk of hyperglycemic diabetic ketoacidosis in type 2 diabetics. In this case we presented a case of hyperglycemic diabetic ketoacidosis in a type 2 diabetic on therapy with dapagliflozin.*Unless otherwise noted, all abstracts presented at ENDO must not be released to the press or the public until the date and time of presentation. For oral presentations, the abstracts are embargoed until the session begins."

Clinical • Monotherapy • Diabetes • Immunology • Infectious Disease • Metabolic Disorders • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Variable Effects of Anti-diabetics on Stress Hyperglycemia Ratio (clinicaltrials.gov) - P=N/A | N=80 | Completed | Sponsor: University of Diyala

New trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • CRP

Ecofriendly Chromatographic Assay of Metformin Combinations; Content Uniformity Tests and Toxicity Profiling. (PubMed, J Chromatogr Sci) - "Accurate, sensitive and green HPTLC chromatographic method was proposed for simultaneous determination of metformin, glipizide and sitagliptin in the presence of metformin potential toxic impurities melamine and cyanoguanidine. The validated method was successfully applied for determination of the studied drugs in Janumet® and Engilor® tablets; also, the results were statistically compared to those obtained by the reported spectrophotometric method and no significant difference was found between them. This method permitted the accurate simultaneous determination of the studied drugs, indicating its ability to be used for routine quality control assays of these drugs."

Journal

Pharmacokinetic comparison of sitagliptin and metformin HCl extended-release tablets versus JANUMET XR in healthy volunteers under fasting and fed conditions. (PubMed, Front Pharmacol) - "The 90% CIs of C, AUC, and AUC in both studies were all within acceptance limits (80.00%-125.00%). The results demonstrated for the first time that sitagliptin 100 mg and metformin 1000 mg produced by Nanjing Chia-Tai Tianqing Pharmaceutical Company was bioequivalent to the branded Janumet XR, and both drugs were well tolerated."

Journal • PK/PD data • Diabetes • Metabolic Disorders

Bioequivalence Study of of Metformin HCl From Gleptomet 50/1000 mg F.C.Tablets (EVA Pharma, Egypt) and Janumet 50/1000 mg F.C.Tablets (Merck Sharp & Dohme, The Netherlands) (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Genuine Research Center, Egypt

New P1 trial

"@Merck how to get Janumet at affordable price for our senior citizen patients? Is there any program in India we can enroll for?" (@vivek1987g)

Clinical

Bioequivalence Evaluation in Healthy Volunteers: New Generic Formulations of Sitagliptin and Sitagliptin-Metformin Fixed-Dose Combination Compared with the Originator Products. (PubMed, Diabetes Ther) - P1 | "The new generic tablet formulations of sitagliptin 100 mg and the FDCs sitagliptin/metformin 50/850 mg and 50/1000 mg demonstrated bioequivalence to originator reference products. Therefore, the new products are expected to provide efficacy and tolerability similar to those of the reference products in the treatment of patients with type 2 diabetes (T2D)."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Drugs for type 2 diabetes. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

"Thanks for sharing. when you say "combo like T2dM", do you mean co-administration or fixed-dose combos (like Janumet)" (@senthilsundaram)

Type 2 Diabetes Mellitus

Insulin clearance and incretin hormones following oral and "isoglycemic" intravenous glucose in type 2 diabetes patients under different antidiabetic treatments. (PubMed, Sci Rep) - "Patients were treated with metformin, sitagliptin, metformin/sitagliptin combination, and placebo (randomized order)...Thus, our data suggest that in T2D there are no relevant incretin effects on insulin clearance. Conversely, different antidiabetic treatments may determine insulin clearance variations."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Metformin-based single pill drug combinations for type 2 diabetes in primary care England: A time trend analysis. (PubMed, Prim Care Diabetes) - "Overall, an increase in prescription items can be seen for metformin-based single pill drug combinations along with an increase in their costs in primary care in England between 2015 and 2020. There was a declining trend for the number of ADRs reported per million prescription items dispensed for metformin-containing single pill combinations, even though their prescription rate increased."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Spectrophotometric Determination of Metformin in Different Pharmaceutical Combinations with Glipizide or Sitagliptin in Presence of Toxic Impurities of Metformin. (PubMed, J AOAC Int) - "The validated method was successfully applied for determination of the studied drugs in Janumet® and Engilor® tablets; moreover the results were statistically compared to those obtained by the reported RP-HPLC method and no significant difference was found between them; indicating the ability of proposed method to be used for routine quality control analysis of these drugs."

Journal

Pharmacokinetics and Bioequivalence of Sitagliptin Phosphate/Metformin Hydrochloride Tablets in Healthy Chinese Subjects: A Randomized, Open-Label, Crossover Study. (PubMed, Drugs R D) - "The two formulations of sitagliptin phosphate/metformin hydrochloride tablets were bioequivalent under fasting and fed conditions in healthy Chinese subjects."

Clinical • Journal • PK/PD data