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 March 2006
Completion Date December 2006
Primary Completion Date December 2006
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

January 2017

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

Source: ClinicalTrials.gov