Comparison of Insulin Glargine Against Insulin Aspart Infused Under the Skin in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00184613
First received: September 12, 2005
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

This trial is conducted in Europe. The objective of the study is to investigate the effect and safety of continously basal delivered insulin aspart given by a pump versus once daily injection of insulin glargine.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Delivery Systems
Device: pump
Drug: insulin glargine
Drug: insulin aspart
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Randomised, In-patient, Cross Over PK/PD Trial Investigating the Pharmackinectic and Pharmacodynamic Profiles Following Continuous Subcutaneous Infusion of Insulin Aspart or Injection of Insulin Glargine in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Variation in morning FPG [ Time Frame: Collected in hospital on the last 5 days of 7 days hospitalization, and on the morning of discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Variation of plasma endogenous insulin and insulin aspart/glargine collected in hospital on the last 5 days and the morning on discharged [ Designated as safety issue: No ]
  • Variation of pre-dinner plasma glucose collected in hospital on the last 3 days [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: May 2005
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with type 2 diabetes for more than 2 years
  • Subjects currently treated with unchanged insulin glargine dose (10 -100 units) for 2 weeks
  • Subjects currently treated with unchanged dose(s) for at least 1 month on one or two Oral Anti-diabetic drugs
  • BMI 25 - 40 kg/m2
  • HbA1c < 9.5 %

Exclusion Criteria:

  • Known or suspected allergy to trial product(s) or related products
  • Previous randomisation in this trial
  • Pregnancy, breast-feeding, intention of becoming pregnant or pre-menopausal women judged not to be using adequate contraceptive measures (Only sterilisation, intra uterine devices and contraceptive pills are considered adequate contraceptive methods)
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding and co-operation.
  • Any other significant illness such as endocrine, cardiac, neurological, malignant or other pancreatic illness judged by Investigator
  • Participation in other studies within the last three months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00184613

Locations
Denmark
Aarhus, Denmark
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Peter Kruse, MD, PhD Novo Nordisk A/S
Study Director: Birgitte K. Berg, MSc Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00184613     History of Changes
Other Study ID Numbers: PDS253-1666, 2005-000268-22
Study First Received: September 12, 2005
Last Updated: June 20, 2012
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014