Qtern is a once-daily oral tablet combining dapagliflozin (an SGLT2 inhibitor) with saxagliptin (a DPP-4 inhibitor) for adults with type 2 diabetes. It offers combined A1C reduction of around 1.0 to 1.5 percent with modest weight loss, but the heart failure signal associated with saxagliptin from the SAVOR-TIMI 53 trial has limited Qtern’s use to patients without significant cardiac risk. Many clinicians prefer Glyxambi (which uses linagliptin instead) when an SGLT2 plus DPP-4 combination is needed.
What Qtern Contains
Qtern is manufactured by AstraZeneca. The single available strength is dapagliflozin 10 mg plus saxagliptin 5 mg. Active ingredients:
- Dapagliflozin — an SGLT2 inhibitor that blocks glucose reabsorption in the proximal tubule of the kidney, allowing approximately 50 to 80 grams of glucose to be excreted in urine daily. Effects include glucose lowering, weight loss of 2 to 4 kg, systolic blood pressure reduction of 3 to 5 mmHg, and demonstrated benefits in heart failure (DAPA-HF) and chronic kidney disease (DAPA-CKD).
- Saxagliptin — a DPP-4 inhibitor that prolongs the activity of GLP-1 and GIP, enhancing glucose-dependent insulin release and suppressing glucagon after meals. The SAVOR-TIMI 53 trial demonstrated cardiovascular non-inferiority overall but raised concern about heart failure hospitalization.
Strength and Dosing
| Strength | Dapagliflozin | Saxagliptin | Frequency |
|---|---|---|---|
| 10/5 mg | 10 mg | 5 mg | Once daily, any time |
Dosing notes:
- Take one tablet once daily, with or without food, at approximately the same time each day.
- If a dose is missed, take it as soon as remembered the same day, then resume the regular schedule. Do not double the next dose.
- Maximum daily dose is one 10/5 mg tablet.
- No 5/5 mg or lower strength is available — patients needing lower dapagliflozin may take Farxiga 5 mg plus Onglyza 5 mg separately.
Who Qtern Is For
Qtern is approved for adults with type 2 diabetes as an adjunct to diet and exercise. Common scenarios:
- A1C remains above goal on metformin alone, and the clinician chooses to add both an SGLT2 and DPP-4 simultaneously
- Patient is already taking dapagliflozin (Farxiga) and saxagliptin (Onglyza) separately and wants to consolidate
- Cardiovascular disease and chronic kidney disease are present (dapagliflozin benefit)
Qtern is generally avoided in patients with heart failure or high heart failure risk because of the saxagliptin signal. It is not approved for type 1 diabetes, diabetic ketoacidosis, or pediatric patients.
How Well It Works
Combined trial data show:
- A1C reduction: approximately 1.0 to 1.5 percent in patients with poorly controlled type 2 diabetes, comparable to other SGLT2 + DPP-4 combinations.
- Weight loss: 2 to 3 kg over 24 to 52 weeks, driven by dapagliflozin.
- Blood pressure: systolic reduction of 3 to 5 mmHg.
- Dapagliflozin outcomes: DAPA-HF and DAPA-CKD trials showed 26 percent reduction in heart failure events and 39 percent reduction in kidney disease progression, respectively.
- Saxagliptin outcomes: SAVOR-TIMI 53 trial showed cardiovascular non-inferiority but a 27 percent increase in heart failure hospitalization — the basis for the FDA warning.
The Heart Failure Concern
The SAVOR-TIMI 53 trial enrolled 16,492 patients with type 2 diabetes and high cardiovascular risk. Heart failure hospitalization occurred in 3.5 percent of saxagliptin patients versus 2.8 percent of placebo, an absolute 0.7 percent increase. Risk was highest in:
- Patients with prior heart failure
- Patients with chronic kidney disease (eGFR less than 60)
- Patients with elevated baseline NT-proBNP
- Patients aged 65 or older
For these populations, alternative DPP-4 inhibitors like linagliptin (with neutral cardiovascular safety in CARMELINA) are preferred. Glyxambi is a direct alternative that combines empagliflozin with linagliptin.
Side Effects
| Side Effect | Source | Frequency |
|---|---|---|
| Urinary tract infections | Dapagliflozin | 5 to 8 percent |
| Genital yeast infections | Dapagliflozin | 4 to 12 percent |
| Upper respiratory infections | Saxagliptin | 5 to 7 percent |
| Headache | Both | 3 to 6 percent |
| Dizziness | Saxagliptin | 3 to 4 percent |
| Increased urination, thirst | Dapagliflozin | 3 to 5 percent |
| Nausea | Saxagliptin | 3 percent |
| Heart failure hospitalization (high-risk patients) | Saxagliptin | ~0.7 percent absolute increase vs placebo |
| Pancreatitis | Saxagliptin | Rare (less than 0.5 percent) |
| Severe joint pain | Saxagliptin (class effect) | Rare |
| Euglycemic DKA | Dapagliflozin | Rare (less than 0.1 percent) |
| Volume depletion, hypotension | Dapagliflozin | 1 to 3 percent |
Contraindications and Warnings
- Hypersensitivity to dapagliflozin or saxagliptin or other DPP-4 inhibitors.
- Active diabetic ketoacidosis.
- eGFR less than 45 mL/min/1.73 m squared: saxagliptin requires dose adjustment that is not available in Qtern (only 5 mg) — switch to separate components if eGFR declines.
- Established heart failure or high risk: use cautiously or avoid; consider Glyxambi.
- History of pancreatitis: use cautiously.
- Type 1 diabetes: not approved.
- Recurrent UTIs or genital infections: use cautiously.
- Pregnancy: not recommended in second or third trimester.
Drug Interactions
- Strong CYP3A4/5 inhibitors (ketoconazole, clarithromycin, ritonavir) increase saxagliptin levels — limit saxagliptin to 2.5 mg, which means switching off Qtern.
- Strong CYP3A4 inducers (rifampin, carbamazepine) can reduce saxagliptin efficacy.
- Loop and thiazide diuretics increase volume depletion risk.
- Insulin and sulfonylureas increase hypoglycemia risk; dose reductions may be needed.
- Lithium: SGLT2 inhibitors can alter lithium clearance.
Cost and Insurance
Qtern retails for approximately $550 to $700 per month at U.S. pharmacies. AstraZeneca’s manufacturer savings card can reduce out-of-pocket cost to $0 to $20 per month for commercially insured patients, with annual savings limits. Medicare and Medicaid patients are not eligible for the savings card but may qualify for income-based patient assistance. Qtern’s narrower clinical niche has resulted in formulary placement variability — some plans cover it readily, others require prior authorization or step therapy.
Storage
- Store at controlled room temperature 68 to 77 degrees F.
- Keep in the original blister or bottle.
- Protect from moisture and heat.
- Do not break, crush, or chew tablets.
Qtern vs Glyxambi
| Feature | Qtern | Glyxambi |
|---|---|---|
| SGLT2 inhibitor | Dapagliflozin 10 mg | Empagliflozin 10 or 25 mg |
| DPP-4 inhibitor | Saxagliptin 5 mg | Linagliptin 5 mg |
| Heart failure signal | Yes (saxagliptin) | No |
| Renal dose adjustment | Limited by saxagliptin (avoid below eGFR 45) | None needed (linagliptin is biliary) |
| Strength options | One fixed (10/5) | Two (10/5 and 25/5) |
| Once-daily? | Yes | Yes |
For most patients needing an SGLT2 + DPP-4 combination, Glyxambi is the preferred choice due to its renal flexibility and the absence of a heart failure signal. Qtern remains an option for patients without heart failure risk who are already established on dapagliflozin and saxagliptin separately and want to simplify.
Place in Type 2 Diabetes Treatment
ADA Standards of Care 2024 prioritize cardiovascular and kidney outcome benefits when selecting second-line agents. SGLT2 inhibitors are strongly preferred in patients with heart failure or chronic kidney disease, while DPP-4 inhibitors are weight-neutral, low-risk add-ons. Qtern’s saxagliptin component conflicts with the heart failure priority, which has narrowed its clinical use. For broader context, see our guide on type 2 diabetes treatment options and the role of saxagliptin (Onglyza) as a standalone product.
Practical Considerations
- Stay well hydrated to support kidney function and reduce dehydration risk.
- Practice good genital hygiene to reduce yeast infection risk.
- Stop and call your clinician for severe abdominal pain, persistent vomiting, fruity breath, or rapid breathing — signs of pancreatitis or DKA.
- Watch for new or worsening shortness of breath, leg swelling, or unexplained weight gain — possible signs of heart failure.
- Monitor kidney function (eGFR) at least annually.
- Inform any new clinician about Qtern, especially before surgery or contrast imaging — hold for 48 hours around contrast.
Why Qtern Is Less Prescribed Today
Three factors have reduced Qtern’s market share:
- Saxagliptin heart failure signal made many clinicians switch to linagliptin-based combinations.
- Single 10/5 strength limits titration — patients needing lower doses must use separate components.
- Renal limitations require switching off Qtern as eGFR declines, since saxagliptin needs dose reduction below 45 that the fixed combination cannot provide.
That said, in patients without heart failure risk and with stable eGFR above 45, Qtern remains a reasonable single-pill option.
The Bottom Line
Qtern combines dapagliflozin 10 mg and saxagliptin 5 mg in one once-daily tablet for adults with type 2 diabetes. Combined A1C reduction is around 1.0 to 1.5 percent, with modest weight loss and blood pressure reduction. The saxagliptin component carries a heart failure hospitalization signal that limits Qtern’s use in patients with established heart failure or high cardiac risk — making Glyxambi the preferred alternative for most patients needing an SGLT2 + DPP-4 combination. Common side effects include genital infections, urinary tract infections, and headache; rare risks include pancreatitis, severe joint pain, and euglycemic DKA. Cost is similar to other brand combinations, with manufacturer copay cards available for commercially insured patients. Talk to your clinician about whether Qtern fits your cardiovascular risk profile and kidney function, or whether an alternative combination would be safer.
