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
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: 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, Globin Zinc
Glargine
Insulin
Insulin, Long-Acting
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014