Drug updated on 9/4/2024
Dosage Form | Tablet (oral; sitagliptin/metformin hydrochloride 50 mg/500 mg); Tablet (oral; sitagliptin/metformin hydrochloride 50 mg/1000 mg) |
Drug Class | Dipeptidyl peptidase-4 inhibitors and metformin hydrochloride |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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Summary
- Janumet (sitagliptin and metformin hydrochloride) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- HbA1C Reduction: Once-weekly Semaglutide significantly improved HbA1C (WMD: -0.98; 95% CI: -1.28, -0.69), with saxagliptin+metformin (MD: -1.91%; 95% CI: -2.85%, -0.97%), liraglutide+metformin (MD: -1.45%; 95% CI: -1.65%, -1.26%), and liraglutide (MD: -0.90%; 95% CI: -1.35%, -0.45%) also showing significant reductions. Gemigliptin had comparable effectiveness to active comparators (MD: 0.09%; 95% CI: -0.06 to 0.23).
- Blood Pressure and Body Weight: Semaglutide significantly reduced systolic blood pressure (WMD: -3.73; 95% CI: -5.42, -2.04) and diastolic blood pressure (WMD: -0.66; 95% CI: -1.02, -0.29), as well as body weight (WMD: -3.17; 95% CI: -3.84, -2.49).
- Glycaemic Targets: Gemigliptin achieved superior outcomes in reaching HbA1C <7% compared to placebo/control at 12 weeks (OR: 5.91; 95% CI: 1.34 to 26.08) and 24 weeks (OR: 4.48; 95% CI: 2.09 to 9.60), but was comparable to active comparators (OR: 0.92; 95% CI: 0.52 to 1.63).
- Semaglutide was associated with an increased rate of total adverse events and premature treatment discontinuation compared to sitagliptin, along with an observed increase in pulse rate (WMD: 3.33; 95% CI: 1.61, 5.06; p-value: <0.00001).
- Liraglutide+metformin was linked to significant adverse effects, such as abdominal pain, while other treatment combinations, including sitagliptin+metformin, did not show significant differences in the incidence of adverse events.
- There is no population-type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Janumet (sitagliptin and metformin hydrochloride) Prescribing Information. | 2022 | Merck Sharp & Dohme LLC., Rahway, NJ, USA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
American Association of Clinical Endocrinology clinical practice guideline: developing a diabetes mellitus comprehensive care plan—2022 update. | 2022 | AACE: Endocrine Practice |
Pharmacologic glycemic management of type 2 diabetes in adults: 2020 update. | 2020 | Canadian Journal of Diabetes |
Portuguese-Brazilian evidence-based guideline on the management of hyperglycemia in type 2 diabetes mellitus. | 2020 | Diabetology & Metabolic Syndrome |