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CompletedNCT00184613Updated Oct 17, 2016

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

A Phase 1 interventional study of pump and insulin glargine in Diabetes, Diabetes Mellitus, Type 2 and Delivery Systems, sponsored by Novo Nordisk A/S. Completed at 1 site in Denmark. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-10-17.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
30 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 2
  • Delivery Systems
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 22 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Interventions

  • Devicepump
  • Druginsulin glargine
  • Druginsulin aspart
06

What researchers measure

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

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Århus C, 8000, Denmark
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00184613
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Sep 16, 2005
Start date
May 2005
Primary completion
Jan 2006
Completion
Jan 2006
Last update
Oct 17, 2016

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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