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Cross-over, double-blind, randomized, single dose euglycemic hyperinsulinemic clamp study to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of NPH recombinant human insulin produced by Biomm/Bioton and the reference product Humulin® N produced by Eli Lilly in type 1 diabetic patients (T1DM).

Trial Profile

Cross-over, double-blind, randomized, single dose euglycemic hyperinsulinemic clamp study to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of NPH recombinant human insulin produced by Biomm/Bioton and the reference product Humulin® N produced by Eli Lilly in type 1 diabetic patients (T1DM).

Not yet recruiting
Phase of Trial: Phase I

Latest Information Update: 20 Jun 2018

At a glance

  • Drugs Insulin suspension isophane (Primary) ; Insulin
  • Indications Type 1 diabetes mellitus
  • Focus Pharmacodynamics; Pharmacokinetics
  • Most Recent Events

    • 20 Jun 2018 New trial record
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