Humalog Mix 50/50
Metabolic· 133 cited findings· 1 source document
Company: Eli Lilly and Company →
What the regulatory reviews say
Humalog Mix 50/50 is indicated for the treatment of patients with diabetes mellitus for the control of hyperglycemia. In clinical studies, for Type 1 diabetes, Fasting Blood Glucose was 209.5 ± 91.6 mg/dL compared to 204.1 ± 89.3 mg/dL for the comparator. One-Hour Postprandial Glucose was 232.4 ± 97.7 mg/dL compared to 250.0 ± 96.7 mg/dL for the comparator, and Two-Hour Postprandial Glucose was 200.9 ± 95.4 mg/dL compared to 231.7 ± 103.9 mg/dL for the comparator. HbA1c was 8.2 ± 1.5 % for both Humalog Mix 50/50 and its comparator.
For Type 2 diabetes, Fasting Blood Glucose was 192.1 ± 67.9 mg/dL compared to 183.1 ± 66.1 mg/dL for the comparator. One-Hour Postprandial Glucose was 238.1 ± 79.7 mg/dL compared to 250.0 ± 75.2 mg/dL for the comparator, and Two-Hour Postprandial Glucose was 217.4 ± 83.2 mg/dL compared to 236.5 ± 80.6 mg/dL for the comparator. HbA1c was 8.2 ± 1.3 % compared to 8.2 ± 1.4 % for the comparator.
Safety findings include weight gain of 0.6 kg with Humulin NPH + SU, 1.2 kg with Humalog a.c. + SU, and 1.5 kg with Humalog a.c. + Humulin N h.s. Hypoglycemia events were 0.11 events/mo with Humulin NPH + SU, 0.03 events/mo with Humalog a.c. + SU, and 0.09 events/mo with Humalog a.c. + Humulin N h.s. Contraindications include hypoglycemia and sensitivity to insulin lispro or any of the excipients. The drug received approval on September 06, 2007.
Key figures — cited to the source page
| Fasting Blood Glucose (Type 1 diabetes) | 209.5 ± 91.6 | LILLY — Humalog Mix 50/50 FDA Review (NDA/BLA 021018, 2020), p.20 |
| Fasting Blood Glucose (Type 1 diabetes) (comparator) | 204.1 ± 89.3 | LILLY — Humalog Mix 50/50 FDA Review (NDA/BLA 021018, 2020), p.20 |
| HbA1c (Type 1 diabetes) | 8.2 ± 1.5 | LILLY — Humalog Mix 50/50 FDA Review (NDA/BLA 021018, 2020), p.20 |
| HbA1c (Type 1 diabetes) (comparator) | 8.2 ± 1.5 | LILLY — Humalog Mix 50/50 FDA Review (NDA/BLA 021018, 2020), p.20 |
| Hypoglycemia events (Humalog a.c. + SU) | 0.03 | LILLY — Humalog Mix 50/50 FDA Review (NDA/BLA 021018, 2020), p.21 |
| Contraindication | hypoglycemia | LILLY — Humalog Mix 50/50 FDA Review (NDA/BLA 021018, 2020), p.39 |
| Indication | treatment of patients with diabetes mellitus for the control of hyperglycemia | LILLY — Humalog Mix 50/50 FDA Review (NDA/BLA 021018, 2020), p.1 |
| Approval Date | September 06, 2007 | LILLY — Humalog Mix 50/50 FDA Review (NDA/BLA 021018, 2020), p.1 |
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.