Approval Status: Approved February 2017
Specific Treatments: inadequately controlled type II diabetes
Qtern combines two antihyperglycemic agents: dapagliflozin, a sodium-glucose cotransporter 2 (SGLT-2) inhibitor, and saxagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor.
Qtern is specifically indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) who have inadequate control with dapagliflozin or who are already treated with dapagliflozin and saxagliptin.
Qtern is supplied as a tablet for oral administration. The recommended dose is a 10 mg dapagliflozin/5 mg saxagliptin tablet taken orally once daily in the morning with or without food. Renal function should be assessed before initiation of therapy and periodically thereafter. Do not initiate Qtern if eGFR is below 60 mL/min/1.73 m2. Discontinue Qtern if eGFR falls persistently below 60 mL/min/1.73 m2. Do not coadminister Qtern with strong cytochrome P450 3A4/5 inhibitors. The tablet should be swallowed whole and not be split or cut.
The FDA approval of Qtern was based on three trials. In two trials, the combination of saxagliptin and dapagliflozin with metformin resulted in statistically significant reductions in HbA1c in comparison to patients treated with placebo. An additional trial showed that the combination of saxagliptin and dapagliflozin added to metformin resulted in statistically superior reductions in HbA1c in comparison to patients treated with saxagliptin or dapagliflozin alone added to metformin.
Adverse events associated with the use of Qtern may include, but are not limited to, the following:
- upper respiratory tract infection
- urinary tract infection
Mechanism of Action
Qtern combines two antihyperglycemic agents: dapagliflozin, a sodium-glucose cotransporter 2 (SGLT-2) inhibitor, and saxagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor. Dapagliflozin: sodium-glucose cotransporter 2 (SGLT-2), expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen. Dapagliflozin is an inhibitor of SGLT-2. By inhibiting SGLT-2, dapagliflozin reduces reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Saxagliptin: Increased concentrations of the incretin hormones such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are released into the bloodstream from the small intestine in response to meals. These hormones cause insulin release from the pancreatic beta cells in a glucose-dependent manner but are inactivated by the DPP-4 enzyme within minutes. GLP-1 also lowers glucagon secretion from pancreatic alpha cells, reducing hepatic glucose production. In patients with type 2 diabetes, concentrations of GLP-1 are reduced but the insulin response to GLP-1 is preserved. Saxagliptin is a competitive DPP-4 inhibitor that slows the inactivation of the incretin hormones, thereby increasing their bloodstream concentrations and reducing fasting and postprandial glucose concentrations in a glucose-dependent manner in patients with type 2 diabetes mellitus.
For additional information regarding Qtern or inadequately controlled type II diabetes, please visit https://www.qtern-hcp.com/