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CompletedNCT01548248Updated Jan 31, 2017

Efficacy and Safety of Levemir® Used as Basal Insulin

An observational study in Diabetes, Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in Slovakia. Per ClinicalTrials.gov, last updated 2017-01-31.

Sponsored by Novo Nordisk A/S · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
631
Sex
All
01

Study summary

This study is conducted in Europe. The aim of this study is to evaluate efficacy and safety of insulin detemir (Levemir®) used as basal insulin on the glycaemic control, weight and incidence of hypoglycaemic events in insulin treated subjects with type 1 or type 2 diabetes treated with insulin NPH under normal clinical practice conditions in Slovakia.

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
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 631 is above the median of 233 across 2,220 observational 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.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Any subject with type 1 or type 2 diabetes treated with human insulin NPH in whom at the discretion of the participating physicians it was decided to switch insulin treatment to the long-acting insulin analogue insulin detemir in combination with insulin aspart. The selection of the subjects was at the discretion of the participating physicians.

Eligibility criteria

Inclusion Criteria:

  • Type 1 or type 2 diabetes treated with insulin NPH
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
631 participants (actual)
Patient registry
No

Groups and cohorts

  • Levemir® users

    Drug: insulin detemir · Drug: insulin aspart

Interventions

  • Druginsulin detemir

    Prescribed insulin detemir and insulin aspart based on the clinical judgement of the physician. The insulin preparations were prescribed by the physician solely as a result of a normal clinical evaluation. The physician determined the starting dose and frequency, as well as later changes to either dose or frequency, if any.

  • Druginsulin aspart

    Prescribed insulin detemir and insulin aspart based on the clinical judgement of the physician. The insulin preparations were prescribed by the physician solely as a result of a normal clinical evaluation. The physician determined the starting dose and frequency, as well as later changes to either dose or frequency, if any.

06

What researchers measure

Primary outcomes

  1. Change in HbA1c (glycosylated haemoglobin)

Secondary outcomes

  1. Change in weight

  2. Change in fasting plasma glucose (FPG)

  3. Change in 4-points glucose profiles

  4. Change in lipid profile

  5. Number of hypoglycaemic events

  6. Number of adverse events

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Bratislava, 811 05, Slovakia
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References and documents

Publications

  • Zuzana N et al; Effect of Basal Insulin Detemir on Weight and Hypoglycemia in T1DM and T2DM; 2025-PO; 69th Scientific Sessions (2009); American Diabetes Association
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01548248
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Mar 8, 2012
Start date
Jan 2006
Primary completion
Oct 2006
Completion
Oct 2006
Last update
Jan 31, 2017

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 Jan 2017. You cannot join it, but the record below documents what was studied.

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