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Type 1: FDA OKs Levemir for Two- to Five-Year-Olds
The US Food and Drug Administration has approved the use of Novo Nordisk's Levemir basal insulin for type 1 children aged two to five years. The FDA decision makes Levemir (insulin detemir [rDNA origin]) the only basal insulin approved for use in this age group.
Levemir, introduced to the US market in 2006, was previously approved for older children and adults with type 1 diabetes, as well as insulin-using type 2s.
The new FDA approval was based on Levemir's performance in reducing the risk of severe hypoglycemic episodes in the two-to-five year age group. Type 1 children in that group who received Levemir and a rapid-acting insulin analog, NovoLog (insulin aspart [rDNA origin] injection), experienced a lower rate of hypoglycemia than those taking NPH and NovoLog. None of the young patients treated with Levemir had a severe hypoglycemic episode, whereas six episodes were reported in three patients treated with NPH over the one-year study period.
Source: Novo Nordisk press release
Categories: Basal, Diabetes, Diabetes Health, FDA, Hypoglycemic Episodes, Insulin, Levemir, Novolog, Type 1, Type 1 Diabetes, Type 1 Issues
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Jun 7, 2012
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Diabetes Health
Diabetes Health is the essential resource for people living with diabetes- both newly diagnosed and experienced as well as the professionals who care for them. We provide balanced expert news and information on living healthfully with diabetes. Each issue includes cutting-edge editorial coverage of new products, research, treatment options, and meaningful lifestyle issues.
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Topics
- Diabetic / Diabetes Health
- Type 1 / 1.5 Diabetes
- Type 2 Diabetes
- Blood Glucose / Sugar
- High/Low Blood Sugar / Fast Acting Glucose
- Insulin- Pumps, Pens & Syringes
- Continuous Glucose Monitors, CGM, Infusion Sets
- Type 2 Medications
- Hyperglycemia
- Hypoglycemia
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