Pharmacology of Insulin Injected With Jet-injection in Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      A previous study showed that absorption and glucose-lowering action of rapid-acting insulin
      analogues occurred twice as fast when these analogues were administered by jet injection
      technology rather than by conventional insulin pen in healthy non-diabetic subjects. This
      study investigates if the rapid-acting insulin analogue aspart (Novorapid®) injected with
      jet-injection or a conventional insulin pen prior to a standardised meal in patients with
      diabetes shows the same difference in the pharmacokinetic and pharmacodynamic profile.
    

Detailed description: 
      A previous study showed that absorption and glucose-lowering action of rapid-acting insulin
      analogues occurred twice as fast when these analogues were administered by jet injection
      technology rather than by conventional insulin pen in healthy non-diabetic subjects. This
      study investigates if the rapid-acting insulin analogue aspart (Novorapid®) injected with
      jet-injection or a conventional insulin pen prior to a standardised meal in patients with
      diabetes (type 1 and type 2) shows the same difference in the pharmacokinetic and
      pharmacodynamic profile.The pharmacokinetic and pharmacodynamic profile of insulin aspart
      will be derived from the time-action profiles of insulin and glucose, respectively, in
      response to insulin injected directly prior to a standardised meal. All patients will be
      investigated twice, where on one occasion the jet-injector device will be used to inject an
      individualised dose of insulin and a conventional insulin pen to inject a placebo solution,
      and on the other occasion insulin will be injected with the conventional pen and placebo with
      the jet-injector. The order of these occasions will be randomised and blinded to both the
      investigator and the participating patient. The primary endpoint is the hyperglycaemic burden
      as reflected by area under the baseline-subtracted plasma glucose concentration time-curve
      from time 0 to 2 h after insulin injection and meal ingestion (BG-AUC0-2h). Secondary study
      endpoints are the area under the baseline-subtracted plasma glucose concentration time-curve
      from time 0 to 6 h (BG-AUC0-6h), maximal glucose excursion (BGmax), time to maximal glucose
      excursion (T-BGmax), time until plasma glucose has returned to baseline (T-BGBL), maximal
      insulin concentration (C-INSmax), time to maximal insulin concentration (T-INSmax), area
      under the insulin concentration curve (INSAUC) and time until 50% of insulin absorption
      (T-INSAUC50%) after insulin injection and meal ingestion.
    

Intervention name(s): jet injection device
Intervention type(s): Device
Intervention description(s): Rapid-acting insulin analogue aspart (Novorapid®) administration by means of a jet injector or a conventional insulin pen in the subcutaneous tissue. Dosage of insulin will be determined by the normal dosage of insulin used by the patient before breakfast.
Other intervention name(s): Jet injector: InsuJet™ from the European Pharma Group; Insulin device: NovoPen® 3 from Novo Nordisk
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Insulin action; Jet injector; Diabetes Mellitus; Pharmacodynamics; Pharmacokinetics; Insulin analogs; Insulin aspart