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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00184613
• Other study ID #: PDS253-1666
• Secondary ID: 2005-000268-22
• Status: Completed
• Phase: Phase 1
• First received: September 12, 2005
• Last updated: October 14, 2016
• Start date: May 2005
• Est. completion date: January 2006

Study information

• Verified date: October 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Delivery Systems
• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Device:
• pump

Drug:
• insulin glargine

• insulin aspart

Locations

Country	Name	City	State
Denmark	Novo Nordisk Investigational Site	Århus C

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation in morning FPG		Collected in hospital on the last 5 days of 7 days hospitalization, and on the morning of discharge	No
Secondary	Variation of plasma endogenous insulin and insulin aspart/glargine collected in hospital on the last 5 days and the morning on discharged			No
Secondary	Variation of pre-dinner plasma glucose collected in hospital on the last 3 days			No

External Links

•   Clinical Trials at Novo Nordisk