Natalie Bellini, DNP, FNP, BC-ADM, CDCES

Once-weekly basal insulin is now a two-product class in the US, and the newest entrant, insulin efsitora alfa-gobe (Onswik), brings a dosing framework distinct from familiar daily basal practice.

, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, reviewed the 

’s approval of efsitora for adults with 

 and its labeled titration strategies. The September 24, 2026, approval rests on the four phase 3 QWINT trials and follows the March 2026 approval of insulin icodec (Awiqli).

Efsitora Dosing and Titration in Type 2 Diabetes

Watch the full episode discussing the FDA’s approval of efsitora alfa-gobe

Dose capacity is a central practical feature. A 400-unit weekly dose equates to roughly 57 units per day, adequate for many patients, while a U-1000 formulation extends dosing for people with marked insulin resistance.

The prescribing information offers two titration approaches drawn from the trial designs. The fixed-dose schedule starts at 100 units weekly, then steps to 150, 250, and 400 units at intervals of at least four weeks while fasting glucose remains above 130 mg/dL. These increments exceed typical daily basal adjustments, and beyond 400 units, titration proceeds in 20- to 40-unit weekly steps.

The flexible schedule relies on a loading dose. With a half-life of roughly 17 days, efsitora would reach target far more slowly without one. Week one therefore begins at 300 units, week two drops to 100 units, and later doses shift by 20 to 40 units based on glucose.

For patients switching from glargine or degludec, clinicians multiply the total daily dose by seven for the weekly equivalent and triple it for the first week. Subsequent weeks revert to the sevenfold conversion with the same 20- to 40-unit adjustments.

Hypoglycemia remains the principal adverse effect, as with any insulin, and dose reduction is advised when it occurs. Several QWINT trials captured continuous glucose monitoring outcomes, adding insight into glycemic variability beyond A1c reduction.

Weekly administration suits patients who struggle with daily injections or depend on caregivers, including older adults who could receive basal insulin alongside a weekly glucagon-like peptide-1 receptor agonist during a single visit. The availability of two concentrations and two titration pathways gives clinicians room to individualize therapy as experience with weekly basal insulin grows.

Editors’ Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others.

Rosenstock J, Bailey T, Connery L, et al. Weekly fixed-dose insulin efsitora in type 2 diabetes without previous insulin therapy. 

Philis-Tsimikas A, Bergenstal RM, Bailey TS, et al. Once-weekly insulin efsitora alfa versus once-daily insulin degludec in adults with type 2 diabetes currently treated with basal insulin (QWINT-3): a phase 3, randomised, non-inferiority trial. 

Blevins T, Dahl D, Pérez Manghi FC, et al. Once-weekly insulin efsitora alfa versus once-daily insulin glargine U100 in adults with type 2 diabetes treated with basal and prandial insulin (QWINT-4): a phase 3, randomised, non-inferiority trial. 

Videos

In this segment from the latest episode of Diabetes Dialogue, Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss dosing guidelines for the recently approved efsitora alfa-gobe.

Once-weekly basal insulin options for adults with 

 have doubled in 2026, with the FDA approval of insulin efsitora alfa-gobe (Onswik) following the March clearance of insulin icodec-abae (Awiqli). Efsitora pairs a fixed weekly regimen with two high-concentration pen formulations built for a wide dosing range.

, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, reviewed the September 24, 2026, approval of Eli Lilly's efsitora, its supporting phase 3 evidence, and practical considerations for prescribing.

FDA Approves a Second Once-Weekly Basal Insulin: What the QWINT Data Show

The approval rests on four phase 3 QWINT trials comparing efsitora with daily insulin glargine U-100 or insulin degludec U-100. Efsitora met the primary endpoint of noninferior A1C reduction in each study, with reductions ranging from 0.81 to 1.26 percentage points. Because insulin trials target comparability rather than superiority, these results support substituting efsitora for daily basal insulin without sacrificing glycemic control.

Hypoglycemia data offer a clearer point of differentiation. Rates of clinically significant or severe hypoglycemia were similar to daily comparators across the program, but insulin-naive participants in QWINT-1 experienced 43% fewer events than those receiving glargine. A flatter steady-state profile may account for the gap, since glargine varies between individuals and may not provide full 24-hour coverage in every patient.

Titration strategy likely contributes as well, and optimal initiation and titration approaches are still being refined, as occurred with icodec. The indication excludes type 1 diabetes, where trials showed higher hypoglycemia rates, although clinicians can envision future use cases in this population.

Dosing logistics differ meaningfully from icodec, a U-700 formulation dosed in 10-unit increments. The efsitora U-500 pen delivers up to 400 units per injection in five-unit increments, while the U-1000 pen delivers up to 800 units in 10-unit increments for patients with higher requirements. Dividing weekly doses by seven gives the daily equivalent, so a 400-unit injection corresponds to roughly 57 units per day.

With two weekly basal insulins now available, clinicians face a new learning curve around pen concentrations, dose increments, and quantities per prescription. Efsitora's hypoglycemia profile in insulin-naive patients may make it an appealing option for basal insulin initiation, where reducing injection burden could help address delays in starting therapy.

In this segment from the latest episode of Diabetes Dialogue, Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the FDA's approval of a new basal insulin for T2D.

Annual urine albumin-to-creatinine ratio (UACR) testing is recommended for every person with 

, yet completion in primary care remains low. The gap leaves early 

 undetected at the stage when intervention offers the greatest benefit.

UACR Screening and Finerenone Safety in Diabetic CKD

, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, examined screening barriers and prescribing considerations surrounding finerenone (Kerendia), the nonsteroidal mineralocorticoid receptor antagonist (MRA) recently approved for CKD associated with type 1 diabetes.

Watch the full episode discussing finerenone’s new approval

Assessments of primary care clinics place annual UACR completion near 20% among patients with diabetes. Missed tests reflect more than ordering lapses, because some patients hesitate to complete a urine test when its purpose goes unexplained. Framing UACR like a mammogram or colonoscopy, as early detection offering more options before disease progresses, may improve adherence.

Patients also benefit from hearing how glycemic control alone will not prevent kidney disease, particularly with coexisting hypertension or dyslipidemia. Explaining the rationale behind each screening test tends to build buy-in, even amid crowded clinic schedules and inbox demands.

Angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) remain first-line for albuminuria, with titration to the maximum tolerated dose. These inexpensive agents form the foundation, and finerenone adds renoprotection on top of them. Because ACE inhibitors, ARBs, and finerenone all raise serum potassium, monitoring becomes essential as therapies are layered.

Resistant hypertension introduces another consideration. Spironolactone, a steroidal MRA, shares a target with finerenone, although the nonsteroidal agent carries a more favorable adverse effect profile. The two should never be combined, mirroring the rule against pairing an ACE inhibitor with an ARB.

For patients already taking spironolactone, starting finerenone calls for reassessing the blood pressure regimen and substituting a different antihypertensive. Clinicians switching between ACE inhibitors and ARBs for cough or inadequate response follow the same logic of choosing one agent per pathway.

Collectively, these considerations position finerenone as an addition to established renin-angiotensin blockade rather than a replacement. Its real-world impact in diabetes will depend on earlier CKD detection through consistent UACR screening and disciplined management of hyperkalemia risk.

Bayer. Bayer’s KERENDIA (finerenone) Receives FDA Approval as the First New Treatment in 30 Years for Adults with Chronic Kidney Disease (CKD) and Type 1 Diabetes. September 17, 2026. Accessed September 18, 2026. 

https://www.bayer.com/en/us/news-stories/treatment-forchronic-kidney-disease-and-type-1-diabetes

In this segment from the latest episode of Diabetes Dialogue, Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss UACR screening for patients with CKD and T1D.

-approved therapy in roughly 30 years, with finerenone (Kerendia) gaining an indication built on dedicated trial data rather than extrapolation.

Finerenone Approval Expands CKD Care in Type 1 Diabetes

On a recent episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discussed the approval of the nonsteroidal mineralocorticoid receptor antagonist (MRA) and the phase 3 FINE-ONE trial behind it.

Evidence gaps have long shaped care in type 1 diabetes. Because far more people live with type 2 diabetes, trials and indications have concentrated there, including finerenone's prior approvals for CKD in type 2 diabetes and for heart failure. Without dedicated data, clinicians could not confirm benefit in type 1 diabetes, and coverage often proved difficult.

FINE-ONE randomized 242 adults across 80 sites in nine countries to finerenone or placebo, each added to standard of care, in a double-blind design. Finerenone reduced the urine albumin-to-creatinine ratio (UACR) by 25% relative to placebo over six months. At any point after baseline, 68.1% of finerenone recipients achieved a UACR reduction of at least 30%, compared with 46.6% of placebo recipients.

The 30% threshold carries clinical weight, as the American Diabetes Association recognizes it as a marker of slower CKD progression. Hyperkalemia occurred more often with finerenone than placebo (10.1% vs 3.3%) and led to discontinuation in 1.7% of patients, reinforcing the need for routine potassium monitoring.

The approval also fills a gap left by sodium-glucose cotransporter 2 (SGLT2) inhibitors. Trials of the class in type 1 diabetes did not use kidney endpoints, and the risk of euglycemic diabetic ketoacidosis, a real concern in practice, has kept these agents from FDA approval in this population.

Finerenone adds to, rather than replaces, control of blood pressure, lipids, and glycemia, each of which drives injury in the small renal arterioles. Its benefit depends on detecting albuminuria, yet annual UACR screening remains underused. Explaining to patients that the urine test looks only for protein, not drug use, can improve participation.

Collectively, the approval gives clinicians a kidney-protective option with dedicated evidence in type 1 diabetes and places renewed emphasis on routine albuminuria screening as the entry point to treatment.

In this segment from the latest episode of Diabetes Dialogue, Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the FDA's recent approval of finerenone for CKD with T1D.

Natalie Bellini, DNP, FNP, BC-ADM, CDCES

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