scroll
for
more

type 2 diabetes

comparable A1C REDUCTION

BASAGLAR demonstrated noninferiority to Lantus® (insulin glargine injection) products (approved in the US or outside the US) as measured by A1C reduction in adult patients with type 2 diabetes1,4

Type 2 diabetes: change in A1C from baseline at 24 weeks

Type 2 diabetes: change in A1C from baseline at 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 products (approved in the US or outside the US) groups, respectively.

Approved in the US or outside the US.

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

A comparable percentage of adult patients with type 2 diabetes achieved A1C <7% at 24 weeks1,4*

Percentage of adults with type 2 diabetes achieved A1C <7% at 24 weeks

*Secondary endpoint.

Full analysis set; n values reflect maximum sample size.

Approved in the US or outside the US.

OAMs=oral anti-diabetic medications.

Trial design: 24-week phase 3, randomized, double-blind trial of 756 adult 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 products (approved in the US or outside the US) along with 2 or more OAMs with adequate or inadequate glycemic control. The primary endpoint was noninferiority of BASAGLAR to Lantus products (approved in the US or outside the US) as measured by change in A1C from baseline at 24 weeks.1,4

The starting dose for all insulin-naive patients was 10 units/day, while patients entering the study on Lantus products (approved in the US or outside the US) were randomized to either BASAGLAR or Lantus products (approved in the US or outside the US) at a dose equivalent to their prestudy Lantus products (approved in the US or outside the US) dose. BASAGLAR and Lantus products (approved in the US or outside the US) titrations were patient-driven based on self-measured fasting plasma glucose with a target of <100 mg/dL.4

type 2 diabetes

adverse events

This trial was not designed to evaluate the relative safety between BASAGLAR and Lantus products (approved in the US or outside the US), and comparator adverse event rates are not an adequate basis for comparison of rates between the products.

BASAGLAR vs Lantus products (approved in the US or outside the US): severe symptomatic hypoglycemia over 24 weeks of treatment4

1%

*Full analysis set; n values reflect maximum sample size.

Approved in the US or outside the US.

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 symptomatic hypoglycemia was defined as an event with symptoms consistent with hypoglycemia that required assistance of another person, and was associated with either blood glucose levels below 50 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration.1,4

Rates of reported hypoglycemia depend upon the definition of hypoglycemia used, diabetes type, insulin dose, intensity of glucose control, background therapies, and other intrinsic and extrinsic factors. For these reasons, comparing rates of hypoglycemia in clinical trials for BASAGLAR with the incidence of hypoglycemia for other products may be misleading, and may not be representative of hypoglycemia rates that will occur in clinical practice.

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

Type 2 diabetes: adverse reactions occurring in ≥5% of adult patients over 24 weeks

*Approved in the US or outside the US.

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.6

OAMs=oral anti-diabetic medications.

type 1 diabetes

comparable A1C REDUCTION

BASAGLAR demonstrated noninferiority to Lantus products (approved in the US or outside the US) as measured by A1C reduction in adult patients with type 1 diabetes1,7

Type 1 diabetes: change in A1C from baseline at 24 weeks

Type 1 diabetes: change in A1C from baseline at 24 weeks

*One patient randomized to the BASAGLAR group was not included in the full analysis set. Observed A1C data at 24 weeks were available from 256 (96%) and 258 (97%) patients randomized to the BASAGLAR and Lantus products (approved in the US or outside the US) groups, respectively.

Approved in the US or outside the US.

CI=confidence interval.

A comparable percentage of adult patients with type 1 diabetes achieved A1C <7% at 24 weeks1,7*

Percentage of adult patients with type 1 diabetes achieved A1C <7% at 24 weeks

*Secondary endpoint.

Full analysis set; n values reflect maximum sample size.

Approved in the US or outside the US.

Trial design: 52-week phase 3, randomized, open-label study of 535 adult patients with type 1 diabetes who were also treated with insulin lispro. The primary endpoint was noninferiority of BASAGLAR to Lantus products (approved in the US or outside the US) as measured by change in A1C from baseline at 24 weeks.1,7

Patients started on the same dose of BASAGLAR or Lantus products (approved in the US or outside the US) and at the same time of day as their prestudy basal insulin; mealtime insulin was replaced with insulin lispro at doses equivalent to prestudy mealtime insulin; titrations were investigator-driven based on self-measured fasting plasma glucose to achieve glycemic targets (A1C <7%, fasting plasma-equivalent glucose ≤108 mg/dL, and other preprandial capillary blood glucoses [70 to 130 mg/dL]).7

type 1 diabetes

ADVERSE EVENTS

This trial was not designed to evaluate the relative safety between BASAGLAR and Lantus products (approved in the US or outside the US), and comparator adverse event rates are not an adequate basis for comparison of rates between the products.

BASAGLAR vs Lantus products (approved in the US or outside the US): severe symptomatic hypoglycemia over 52 weeks of treatment7

4%

*Full analysis set; n values reflect maximum sample size.

Approved in the US or outside the US.

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 symptomatic hypoglycemia was defined as an event with symptoms consistent with hypoglycemia that required assistance of another person, and was associated with either blood glucose levels below 50 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration.1,7

Rates of reported hypoglycemia depend upon the definition of hypoglycemia used, diabetes type, insulin dose, intensity of glucose control, background therapies, and other intrinsic and extrinsic factors. For these reasons, comparing rates of hypoglycemia in clinical trials for BASAGLAR with the incidence of hypoglycemia for other products may be misleading, and may not be representative of hypoglycemia rates that will occur in clinical practice.

Type 1 diabetes: adverse reactions occurring in ≥5% of adult patients over 52 weeks1,8

Type 1 diabetes: adverse reactions occurring in ≥5% of adult patients over 52 weeks

*Approved in the US or outside the US.

Infections other than nasopharyngitis or upper respiratory tract infection.

Infections were a category of treatment-emergent adverse events that were reported during the 52-week trial and included events such as influenza, urinary tract infection, bronchitis, gastroenteritis, and sinusitis. Excluded were nasopharyngitis and upper respiratory tract infection.9