Comparing Insulin Aspart With Fast-acting Insulin Human in Subjects With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01269606
First received: January 3, 2011
Last updated: June 15, 2012
Last verified: June 2012

January 3, 2011
June 15, 2012
January 2011
March 2011   (final data collection date for primary outcome measure)
  • Clearance at steady state (CLss) for IV treatment group [ Time Frame: from 180 min to 240 min ] [ Designated as safety issue: No ]
  • Area under the curve (AUC) for IM treatment group [ Time Frame: from 0 to 480 min after intramuscular injection ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01269606 on ClinicalTrials.gov Archive Site
  • Area under the curve (AUC) for IM treatment group [ Time Frame: from 0 minutes to infinite time after intramuscular injection ] [ Designated as safety issue: No ]
  • Steady state concentration (Css) for IV treatment group [ Time Frame: from 180 min to 240 min ] [ Designated as safety issue: No ]
  • Hypoglycaemic episodes [ Time Frame: from screening (visit 1) to follow-up visit (2-21 days after last trial product administration) ] [ Designated as safety issue: No ]
  • Adverse Events (AEs) [ Time Frame: from first trial related activity to follow-up visit (2-21 days after last trial product administration) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparing Insulin Aspart With Fast-acting Insulin Human in Subjects With Type 1 Diabetes
A Trial Comparing the Pharmacokinetic Properties of Insulin Aspart With Fast-acting Insulin Human Following Intravenous Infusion or Intramuscular Injection in Japanese Subjects With Type 1 Diabetes Mellitus

This trial is conducted in Japan. The aim of the trial is to compare pharmacokinetics (at which rate the body eliminates the substance from the body) of insulin aspart with fast-acting insulin human following intravenous (IV) infusion or intramuscular (IM) injection in Japanese subjects with type 1 diabetes mellitus.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Drug: insulin aspart
    At the first treatment visit, a single dose of insulin aspart at 0.2 U/kg via IM (in the muscle) injection is administered. At the second treatment visit, a single dose of fast-acting insulin human at 0.2 IU/kg via IM (in the muscle) injection is administered. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment visits.
  • Drug: insulin human
    At the first treatment visit, a single dose of fast-acting insulin human at 0.2 IU/kg via IM (in the muscle) injection is administered.At the second treatment visit, a single dose of insulin aspart at 0.2 U/kg via IM (in the muscle) injection is administered. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment periods.
  • Drug: insulin aspart
    At the first treatment visit, insulin aspart is intravenously infused for 24 minutes, with rate of 1.25 mU/kg/min at constant phase. At the second treatment visit, fast-acting insulin human is intravenously infused for 24 minutes, with rate of 1.25 mIU/kg/min at constant phase. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment visits.
  • Drug: insulin human
    At the first treatment visit, fast-acting insulin human is intravenously infused for 24 minutes, with rate of 1.25 mIU/kg/min at constant phase. At the second treatment visit, insulin aspart is intravenously infused for 24 minutes, with rate of 1.25 mU/kg/min at constant phase. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment periods.
  • Experimental: Treatment sequence 1 - IM treatment group
    Intervention: Drug: insulin aspart
  • Experimental: Treatment sequence 2 - IM treatment group
    Intervention: Drug: insulin human
  • Experimental: Treatment sequence 1 - IV treatment group
    Intervention: Drug: insulin aspart
  • Experimental: Treatment sequence 2 - IV treatment group
    Intervention: Drug: insulin human
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
March 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
  • Treated with multiple daily insulin injections for at least 12 months
  • Current daily basal insulin requirement above or equal to 0.3 U/kg/day
  • Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0%
  • Body Mass Index (BMI) 18.0-28.0 kg/m^2

Exclusion Criteria:

  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start (screening)
  • Surgery or trauma with significant blood loss (more than 500 mL) within 3 months prior to trial start (screening)
  • Subject who smokes more than 10 cigarettes or the equivalent per day
  • Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Both
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01269606
ANA-3877, U1111-1117-1353, Japic No
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Akane Shimizu Novo Nordisk Pharma Ltd.
Study Director: Kensuke Kanki Novo Nordisk Pharma Ltd.
Novo Nordisk A/S
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP