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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 ± 91.6LILLY — Humalog Mix 50/50 FDA Review (NDA/BLA 021018, 2020), p.20
Fasting Blood Glucose (Type 1 diabetes) (comparator)204.1 ± 89.3LILLY — Humalog Mix 50/50 FDA Review (NDA/BLA 021018, 2020), p.20
HbA1c (Type 1 diabetes)8.2 ± 1.5LILLY — Humalog Mix 50/50 FDA Review (NDA/BLA 021018, 2020), p.20
HbA1c (Type 1 diabetes) (comparator)8.2 ± 1.5LILLY — Humalog Mix 50/50 FDA Review (NDA/BLA 021018, 2020), p.20
Hypoglycemia events (Humalog a.c. + SU)0.03LILLY — Humalog Mix 50/50 FDA Review (NDA/BLA 021018, 2020), p.21
ContraindicationhypoglycemiaLILLY — Humalog Mix 50/50 FDA Review (NDA/BLA 021018, 2020), p.39
Indicationtreatment of patients with diabetes mellitus for the control of hyperglycemiaLILLY — Humalog Mix 50/50 FDA Review (NDA/BLA 021018, 2020), p.1
Approval DateSeptember 06, 2007LILLY — Humalog Mix 50/50 FDA Review (NDA/BLA 021018, 2020), p.1

Source documents

Explore the full evidence

All 133 cited findings for Humalog Mix 50/50 — searchable, comparable and answerable in plain language — are in the Metabolic research library →

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.