Levemir(insulin detemir)
Metabolic· 366 cited findings· 2 source documents
Company: NOVO NORDISK INC
What the regulatory reviews say
Levemir (insulin detemir) is an insulin analog indicated for the treatment of diabetes. Regulatory review documents indicate an absolute bioavailability of 60% and a terminal half-life of 5 to 7 hours. Levemir was found to be bioequivalent in a randomized, single-center, two-way crossover study.
Clinical trials demonstrated reductions in HbA1c and Fasting Plasma Glucose (FPG). Mean changes from baseline in HbA1c ranged from -0.60% to -1.90%, and FPG mean changes from baseline ranged from -10.80 mg/dL to -45.00 mg/dL. In some trials, 70% to 74% of patients achieved an HbA1c of ≤ 7%.
Safety data reported major hypoglycemia events ranging from 0.027 to 0.083 events/subject/month, and minor hypoglycemia events ranging from 2.184 to 3.063 events/subject/month. Levemir received approval on April 11, 2007, under NDA 21-536.
Key figures — cited to the source page
| Absolute bioavailability | 60 | NOVO NORDISK INC — Levemir FDA Review (NDA/BLA 021536, 2020), p.10 |
| Terminal half-life | 5 to 7 | NOVO NORDISK INC — Levemir FDA Review (NDA/BLA 021536, 2020), p.10 |
| HbA1c mean change from baseline (%) | -1.90 | NOVO NORDISK INC — Levemir FDA Review (NDA/BLA 021536, 2020), p.66 |
| Proportion achieving HbA1c ≤ 7% | 74 | NOVO NORDISK INC — Levemir FDA Review (NDA/BLA 021536, 2020), p.66 |
| Major hypoglycemia (events/subject/month) | 0.027 | NOVO NORDISK INC — Levemir FDA Review (NDA/BLA 021536, 2020), p.70 |
| Minor hypoglycemia (events/subject/month) | 2.184 | NOVO NORDISK INC — Levemir FDA Review (NDA/BLA 021536, 2020), p.70 |
| NDA number | 21-536 | NOVO NORDISK INC — Levemir FDA Review (NDA/BLA 021536, 2020), p.49 |
| Approval status | Approval | NOVO NORDISK INC — Levemir FDA Review (NDA/BLA 021536, 2020), p.51 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.