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Observational Study to Evaluate the Effectiveness and Safety of Levemir®, NovoMix® 30 and NovoRapid® in Insulin naïve Subjects With Type 2 Diabetes

Evaluation of Effectiveness and Safety of Levemir® (Insulin Detemir), NovoMix® (Biphasic Insulin Aspart) and/or NovoRapid® (Insulin Aspart) in Insulin naïve Subjects With Type 2 Diabetes.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00771680
Enrollment
10408
Registered
2008-10-13
Start date
2008-10-31
Completion date
2010-07-31
Last updated
2016-10-28

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 and Asia. The aim of this observational study is to evaluate the effectiveness and the incidence of serious adverse reactions while using Levemir®, NovoMix® and/or NovoRapid® in subjects with type 2 diabetes that have not used insulin previously under normal clinical practice conditions.

Interventions

DRUGinsulin detemir

Start dose and frequency at the discretion of the physician following clinical practice

DRUGbiphasic insulin aspart 30

Start dose and frequency at the discretion of the physician following clinical practice

DRUGinsulin aspart

Start dose and frequency at the discretion of the physician following clinical practice

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Any insulin näive type 2 diabetic patient that able to use the drug as judged by the investigator

Exclusion criteria

* In accordance with approved label

Design outcomes

Primary

MeasureTime frame
HbA1cat baseline visit and during 3, 6, 9 and 12 months
Serious adverse drug reactions including major hypoglycaemic eventsduring 12 months of treatment

Secondary

MeasureTime frame
Number of all minor (daytime and nocturnal) hypoglycaemic eventsDuring 4 weeks prior to each study visit
Weight (BMI) changeAt 6 and 12 months
Number of serious adverse drug reactionsduring 12 months of treatment
Average post-prandial blood glucose level (2h after dinner)At baseline visit and after 6 and 12 months treatment
Quality of Life (QoL) as assessed by patient questionnaireAt baseline and the end of 6 and 12 months treatment
Variability in fasting blood glucose values and average (mean) fasting blood glucose levelAt baseline visit and after 6 and 12 months treatment
Number of all major (daytime and nocturnal) hypoglycaemic eventsduring 12 months of treatment

Countries

Russia, Ukraine

Outcome results

None listed

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