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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00184613
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : October 17, 2016
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Delivery Systems Device: pump Drug: insulin glargine Drug: insulin aspart Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : May 2005
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Primary Outcome Measures :
  1. Variation in morning FPG [ Time Frame: Collected in hospital on the last 5 days of 7 days hospitalization, and on the morning of discharge ]

Secondary Outcome Measures :
  1. Variation of plasma endogenous insulin and insulin aspart/glargine collected in hospital on the last 5 days and the morning on discharged
  2. Variation of pre-dinner plasma glucose collected in hospital on the last 3 days

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00184613

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Novo Nordisk Investigational Site
Århus C, Denmark, 8000
Sponsors and Collaborators
Novo Nordisk A/S
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
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Responsible Party: Novo Nordisk A/S Identifier: NCT00184613    
Other Study ID Numbers: PDS253-1666
2005-000268-22 ( EudraCT Number )
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin Glargine
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs