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Completed

NCT Number: NCT00184613

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

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.

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Key information

Conditions

Diabetes Delivery Systems Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Århus C, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pump

Device

insulin glargine

Drug

insulin aspart

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 16, 2005
Registry last updated
Oct 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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