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

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin aspart; Drug: insulin detemir

• Registration Number: NCT01487421
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Study First Submitted: 2011-11-25
• Study First Submitted QC: 2011-12-05
• Study First Posted: 2011-12-07
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-23
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2134

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SIT	insulin aspart	-
SIT	insulin detemir	-

Primary Outcome Measures

Name	Time	Method
HbA1c (glycosylated haemoglobin)

Secondary Outcome Measures

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