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A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, BIAsp70, BIAsp50 and Fast-acting Human Insulin

This study has been completed.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00888732
First received: April 27, 2009
Last updated: April 27, 2011
Last verified: April 2011
  Purpose

The hypothesis is that an optimal formulation of fast acting and intermediary acting insulin analogues will improve post prandial glycaemic control in patients with type 1 diabetes


Condition Intervention Phase
Diabetes Mellitus, Type 1
Drug: Insulin Aspart, BIAsp 70, BIAsp50, Human Insulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, Biphasic Insulin Aspart 70 and 50 & Fast-acting Human Insulin in Patients With Type 1 Diabetes, A Randomised, Quadruple Crossover Trial

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Cmaxglu: Peak plasma glucose following test meal (breakfast). A comparison will be made between fast-acting human insulin vs. IAsp, BIAsp 50 and BIAsp 70, IAsp vs BIAsp 50 and BIAsp 70, BIAsp 50 vs. BIAsp 70. [ Time Frame: 12 hours following a standard test meal (breakfast) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUCglu: The area under the plasma glucose concentration (0-12, 0-6, 6-12, 0-4, 4-8, 8-12 hours after test meal) after a single injection of one of the four insulins: IAsp, Biphasic insulin aspart 50 and 70 & fast-acting human insulin [ Time Frame: 12 hours following a standard test meal (breakfast) ] [ Designated as safety issue: No ]
  • AUCins: The area under insulin aspart/human insulin concentration (0-12, 0-6, 6-12, 0-4, 4-8, 8-12 hours after test meal) after a single injection of one of the four insulins: IAsp, Biphasic insulin aspart 50 and 70 & fast-acting human insulin [ Time Frame: 12 hours following a standard test meal (breakfast) ] [ Designated as safety issue: No ]
  • tmaxins: Time to maximum serum insulin aspart/human insulin concentration [ Time Frame: 12 hours following a standard test meal (breakfast) ] [ Designated as safety issue: No ]
  • Serum GH, total IGF-I, IGF-I bioactivity, IGFBP-1, IGFBP-2, binary complex of IGF-I, IGFBP-3 and the acid-labile subunit (ALS) [ Time Frame: 12 hours following a standard test meal (breakfast) ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: June 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin therapy
Insulin Aspart, Biphasic Insulin Aspart 70 and 50 & Fast-acting Human Insulin
Drug: Insulin Aspart, BIAsp 70, BIAsp50, Human Insulin
0.2 U/IU/kg subcutaneous injection, single dose
Other Names:
  • - Insulin Aspart: NovoRapid
  • - BIAsp 50: NovoMix 50
  • - BIAsp 70: NovoMix 70
  • - Human Insulin: Actrapid

Detailed Description:

This trial is a single centre, open-label, randomised 4 period cross-over trial, comparing the pk and pd profiles of IAsp, BIAsp 50, BIAsp 70 and Fast-acting Human Insulin after a standard test meal in subjects with type 1 diabetes. The profiles will be derived over a 12-hour period after subcutaneous injection in the abdominal region with a single dose of IAsp, BIAsp 50, BIAsp 70 or Fast-acting Human Insulin at a test meal. The trial consists of a screening period of 4-21 days and 4 treatment visits.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities.
  • Diagnosed type 1 diabetes before the age of 40 and on insulin treatment within one year of diagnosis.
  • Insulin treatment of any regime for more than one year at time of inclusion.
  • Total insulin demand ≥ 0,4 U/IU/kg/24 hrs
  • HbA1c between 7% and 12% (both values included).
  • Age ≥ 18 years.
  • BMI between 18 and 35 kg /m2 (including both values).

Exclusion Criteria:

  • Known or suspected allergy to trial product(s) or related products.
  • Recurrent major hypoglycaemic episodes.
  • Heart: Unstable Angina Pectoris, AMI < 12 months or heart insufficiency classified according to NYHA III-IV
  • Blood Pressure: Severe uncontrolled hypertension with BP > 180/110 mmHg, sitting
  • Liver: Impaired hepatic function corresponding to serum-ALAT or basic phosphatase > 2 x upper reference limit of the local laboratory.
  • Kidneys: Impaired renal function corresponding to serum-creatinin > 150 μmol/l according to the local laboratory.
  • Any disease judged by the investigator to affect the trial.
  • Pregnancy, breast-feeding or the intention of becoming pregnant or fertile women not using adequate contraceptive measures - adequate contraceptive method is sterilisation, hysterectomy or current use of contraceptive pills or intra uterine device.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888732

Locations
Denmark
Dept of Medicine M, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Novo Nordisk A/S
Investigators
Principal Investigator: Jens S Christiansen, M.D University of Aarhus
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jens Sandahl Christiansen, M.D., University of Aarhus
ClinicalTrials.gov Identifier: NCT00888732     History of Changes
Other Study ID Numbers: Asp-BIAsp-HI-2008, 2008-007176-22
Study First Received: April 27, 2009
Last Updated: April 27, 2011
Health Authority: Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Biphasic Insulins
Insulin
Insulin Aspart
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014