Pharmacokinetics of IAsp Following CSII in Patients With T1DM

NCT00497536 | Completed Phase 4 DMC

• 1 other identifier: 2007-001912-21
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to compare SSPIAsp during CSII giving one bolus per hour compared with multiple boluses per hour. The secondary objective is to compare SSPIAsp during continuous subcutaneous insulin infusion (CSII) versus continuous intravenous insulin infusion (CIII).

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes Mellitus; Continuous Subcutaneous Insulin Infusion (CSII)

Outcome Measures

Primary Outcomes (1)

• CV SSPIasp

  6 hours

Secondary Outcomes (1)

• • Δ SSPIAsp (S.C. /I.V.) • AUC IAsp • Tmax IAsp • Cmax IAsp - Bioequivalence of Iasp under SS (GIR, S-FFA, S-glycerol)

  6 hours

Study Arms (3)

1

ACTIVE COMPARATOR

≈ bolus protocol.

Drug: Insulin Aspart (IAsp)

2

ACTIVE COMPARATOR

≈ CSII protocol

Drug: Insulin Aspart (IAsp).

3

ACTIVE COMPARATOR

≈ CIII protocol.

Drug: Insulin Aspart (IAsp)

Interventions

Insulin Aspart (IAsp) DRUG

IAsp 100 U. ≈ bolus protocol: From 6 pm until 6 am • 50 % of habitual 24 hour insulin need/24 hours = basal rate (per hour) From 8 am until 6 pm 1 dose/h + 50 % s.c. (≈ bolus).

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Type 1 diabetes mellitus (T1DM)
• Insulin pump users' ≥ 48 hours, 24 h dose \< 80 U
• Insulin dose ≥ 0,4 IE/kg/24hours
• years \< age \< 50 years
• Time since diagnosis of T1DM ≥ 5 years
• HbA1c ≤ 8,5 %
• Safe anticonceptive for fertile women
• Being able to understand and read Danish

You may not qualify if:

• Dysregulation of endocrine disorders other than type 1 diabetes mellitus
• Severe dysregulation of diabetes mellitus
• Other severe adverse disease
• Pregnancy, planning pregnancy, or nursing

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Medicinsk Endokrinologisk Afdeling M

Aarhus C, Central Jutland, 8000, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Torsten Lauritzen, MD

  University of Aarhus

  STUDY DIRECTOR

• Torben Laursen, MD

  University of Aarhus

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 4, 2007
• First Posted: July 6, 2007
• Study Start: July 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: February 5, 2009

Record last verified: 2009-02

Locations

DK (1)