An Observational Study in Patients Using NovoMix® 30 or Levemir® for Treatment of Type 1 or Type 2 Diabetes Mellitus

A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 1 or Type 2 Diabetes Mellitus in Macedonia

Sponsors

Lead Sponsor: Novo Nordisk A/S

Source Novo Nordisk A/S
Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate efficacy and safety of NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) in subjects with type 1 or 2 diabetes mellitus.

Overall Status Completed
Start Date 2006-03-01
Completion Date 2006-12-01
Primary Completion Date 2006-12-01
Study Type Observational
Primary Outcome
Measure Time Frame
HbA1c (glycosylated haemoglobin)
Secondary Outcome
Measure Time Frame
Percentage of subjects reaching HbA1c target of maximum 7.0%
Postprandial plasma glucose (PPG)
Fasting plasma glucose (FPG)
Change in body weight
Incidence of adverse events
Enrollment 1889
Condition
Intervention

Intervention Type: Drug

Intervention Name: biphasic insulin aspart 30

Description: Prescribed at the discretion of the physician

Arm Group Label: BIAsp 30 users

Intervention Type: Drug

Intervention Name: insulin detemir

Description: Prescribed at the discretion of the physician

Arm Group Label: IDet users

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

Inclusion Criteria: - Macedonian people with diabetes mellitus (Type 1 or Type 2)

Gender:

All

Minimum Age:

N/A

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Global Clinical Registry (GCR, 1452) Study Director Novo Nordisk A/S
Location
Facility: Novo Nordisk Investigational Site
Location Countries

Macedonia, The Former Yugoslav Republic of

Verification Date

2017-01-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: BIAsp 30 users

Label: IDet users

Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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