Models used for illustrative purposes only. Not an actual patient and HCP.

First times can be challenging.

A patient’s first experience with a basal insulin is no exception.

In patients with type 1 diabetes, BASAGLAR must be used concomitantly with short-acting insulin.1

INDICATION

BASAGLAR is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

LIMITATION OF USE

BASAGLAR is not recommended for the treatment of diabetic ketoacidosis.

SELECT IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

BASAGLAR is contraindicated during episodes of hypoglycemia, and in patients with hypersensitivity to insulin glargine or any of the excipients in BASAGLAR.

Consider the ABCs of BASAGLAR® (insulin glargine) injection 100 units/mL

Available resources designed to be simple

And help your patients accept, start, and stay on basal insulin

Learn more about available resources

Backed by savings and support

Lilly is committed to helping people with diabetes access affordable medicines.

Through the Lilly Insulin Value Program, all Lilly insulins are available for $35 a month whether patients have commercial insurance or no insurance.*

These savings cover all Lilly insulins.

*Terms and conditions apply. At retail pharmacies. Government restrictions exclude people enrolled in federal government insurance programs from Lilly's $35 solutions. But federal law provides that Medicare Part D beneficiaries also pay no more than $35 per month for insulin.

Terms, Conditions and Limitations apply to the Insulin Value Savings Card. Click on the following sections for details.

SELECT IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

BASAGLAR prefilled pens must never be shared between patients, even if the needle is changed. Sharing poses a risk of transmission of blood borne pathogens.

Comparable A1C reduction

BASAGLAR demonstrated noninferiority to Lantus® (insulin glargine) as measured by A1C reduction in adult patients with type 2 diabetes.1,2

BASAGLAR vs Lantus plus 2 or more OAMs (24 weeks)

  • A1C reduction from baseline
    • Noninferiority demonstrated: A1C reduction from baseline at 24 weeks1,2
    • BASAGLAR (n=376; baseline A1C: 8.35%): 1.3%
    • Lantus (n=380; baseline A1C: 8.31%): 1.3%
    • Difference of 0.052% (95% CI -0.070 to 0.175)
    • The primary efficacy outcome was to test the noninferiority (0.4% and then 0.3% margin) of BASAGLAR to Lantus, as measured by change in A1C from baseline to 24 weeks

Three patients randomized to BASAGLAR did not receive study drug and were not included in the full analysis set. Observed A1C data at 24 weeks were available from 331 (88%) and 329 (87%) patients randomized to the BASAGLAR and Lantus groups, respectively.

See full trial design information below.

Type 2 diabetes: Adverse reactions occurring in ≥5% of adult patients treated with BASAGLAR or Lantus over 24 weeks of treatment1,3

The trial was not designed to evaluate the relative safety between BASAGLAR and Lantus, and comparator adverse event rates are not an adequate basis for comparison of rates between the products.

Adverse Events BASAGLAR
+ OAMs (n=376)
Lantus
+ OAMs (n=380)
Adverse Events Infection§|| BASAGLAR + OAMs (n=376): 17% Lantus + OAMs (n=380): 16%
Adverse Events Nasopharyngitis BASAGLAR + OAMs (n=376): 6% Lantus + OAMs (n=380): 6%
Adverse Events Upper respiratory tract infection BASAGLAR + OAMs (n=376): 5% Lantus + OAMs (n=380): 4%

§ Infections other than nasopharyngitis or upper respiratory tract infection.

||Infections were a category of treatment-emergent adverse events that were reported during the 24-week trial and included events such as influenza, urinary tract infection, bronchitis, gastroenteritis, and sinusitis. Excluded were nasopharyngitis and upper respiratory tract infection.4

Hypoglycemia was the most commonly observed adverse reaction in patients using insulin, including BASAGLAR. Hypoglycemia was defined as blood glucose ≤3.9 mmol/L (≤70 mg/dL) or a sign or symptom associated with hypoglycemia. Severe hypoglycemia can cause seizures, may be life-threatening, or cause death.

CI=confidence interval; OAMs=oral anti-diabetic medications.

Learn more about BASAGLAR Efficacy and Safety

Trial design: 24-week phase 3, randomized, double-blind trial of 756 patients with type 2 diabetes who were either insulin-naive and failed to achieve adequate glycemic control on at least 2 OAMs, or were already on Lantus along with 2 or more OAMs with adequate or inadequate glycemic control. The primary endpoint was noninferiority of BASAGLAR to Lantus as measured by change in A1C from baseline at 24 weeks.1,2

The starting dose for all insulin-naive patients was 10 U/day, while patients entering the study on Lantus were randomized to either BASAGLAR or Lantus at a dose equivalent to their prestudy Lantus dose; BASAGLAR and Lantus titration was patient-driven based on self-measured fasting plasma glucose with a target of ≤100 mg/dL.2

SELECT IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Changes in insulin strength, manufacturer, type, injection site, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Any changes in insulin regimen should be made cautiously and only under close medical supervision, and the frequency of blood glucose monitoring should be increased. Due to reports of hypoglycemia and hyperglycemia, advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor blood glucose. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.

References:

  1. BASAGLAR. Prescribing Information. Lilly USA, LLC.
  2. Rosenstock J, Hollander P, Bhargava A, et al. Diabetes Obes Metab. 2015;17:734-741.
  3. Data on file, Lilly USA, LLC. BAS20160408A.
  4. Data on file, Lilly USA, LLC. BAS20160811B.

IMPORTANT SAFETY INFORMATION

Contraindications -

BASAGLAR is contraindicated during episodes of hypoglycemia, and in patients with hypersensitivity to insulin glargine or any of the excipients in BASAGLAR.

Warnings and Precautions

BASAGLAR prefilled pens must never be shared between patients, even if the needle is changed. Sharing poses a risk of transmission of blood borne pathogens.

Changes in insulin strength, manufacturer, type, injection site, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Any changes in insulin regimen should be made cautiously and only under close medical supervision, and the frequency of blood glucose monitoring should be increased. Due to reports of hypoglycemia and hyperglycemia, advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor blood glucose. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.

Hypoglycemia is the most common adverse reaction associated with insulins, including BASAGLAR. Severe hypoglycemia can cause seizures, may be life-threatening, or cause death.

Accidental mix-ups between insulin products have been reported. To avoid hypoglycemia due to medication errors between BASAGLAR and other insulins, instruct patients to always check the insulin label before each injection.

Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulins, including BASAGLAR. If hypersensitivity reactions occur, discontinue BASAGLAR; treat per standard of care and monitor until symptoms and signs resolve. BASAGLAR is contraindicated in patients who have had hypersensitivity reactions to insulin glargine or one of the excipients.

All insulins, including BASAGLAR, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia if indicated.

Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. These patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of TZD must be considered.

Adverse Reactions

Adverse reactions commonly (>5%) associated with insulin glargine products are: hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus, rash, edema, and weight gain.

Drug Interactions

Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose.

The risk of hypoglycemia may increase when antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), and sulfonamide antibiotics are co-administered with BASAGLAR.

The blood glucose lowering effect of BASAGLAR may decrease when co-administered with atypical antipsychotics, corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. The blood glucose lowering effect of BASAGLAR may increase or decrease when co-administered with alcohol, beta-blockers, clonidine, lithium salts, and pentamidine.

The signs and symptoms of hypoglycemia may be blunted when beta-blockers, clonidine, guanethidine, and reserpine are co-administered with BASAGLAR.

BV HCP ISI 14SEP2022

For more information, please see accompanying Full Prescribing Information and Patient Information. Please see Instructions for Use.

INDICATION

BASAGLAR is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

Limitations of Use: BASAGLAR is not recommended for the treatment of diabetic ketoacidosis.