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An Observational Study of Insulin Aspart and, if Necessary, Insulin Levemir (FlexPen®) in the Evening or at Bedtime

The Physiological Therapy of Type 2 Diabetes - NovoRapid® FlexPen® Before Meals, Additionally Levemir® FlexPen® in the Evening or at Bedtime if Needed

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01487421
Enrollment
2134
Registered
2011-12-07
Start date
2003-07-31
Completion date
2006-10-31
Last updated
2014-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

Brief summary

This study is conducted in Europe. The aim of this study is investigate the potential of a supplementary insulin therapy regimen (SIT) as intensification for insufficiently controlled patients with type 2 diabetes in a normal diabetes care setting.

Interventions

DRUGinsulin aspart

Subjects were observed over a time period of 12 weeks after initiation of a supplementary insulin therapy regimen (SIT) with insulin aspart at mealtimes. Administrated subcutaneously (s.c., under the skin)

DRUGinsulin detemir

Insulin detemir were added to insulin aspart in the evening or at bedtime, if needed. Administrated subcutaneously (s.c., under the skin)

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Type 2 diabetes * OAD monotherapy * OAD combination therapy * Therapy with OAD and basal insulin * Conventional insulin therapy with premixed insulin

Design outcomes

Primary

MeasureTime frame
HbA1c (glycosylated haemoglobin)

Secondary

MeasureTime frame
Fasting blood glucose (FBG)
2-hours postprandial blood glucose
Hypoglycemia
Weight development
Adverse Drug Reactions (ADRs) including Serious Adverse Drug Reactions (SADRs)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026