Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen® in Insulin Naive Subjects With Type 2 Diabetes

Phase 4

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2

• Registration Number: NCT00600366
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on blood glucose control in insulin naive type 2 diabetes failing on secondary oral hypoglycaemic agent (OHA).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2005-01
• Study Completion: 2005-01
• Study First Submitted: 2008-01-14
• Study First Submitted QC: 2008-01-14
• Study First Posted: 2008-01-25
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-05
• Last Update Posted: 2017-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• Type 2 diabetes
• Insulin naive diabetes
• Current treatment with OHA, secondary failure
• Body mass index (BMI) below 40 kg/m2
• HbA1c over 8.5%
• Willing and able to start with insulin therapy and to perform self-blood glucose monitoring

Exclusion Criteria

• History of drug or alcohol abuse
• Receipt of the investigational drug within the last month prior to this trial
• Known or suspected allergy to trial products or related products
• Severe uncontrolled hypertension
• Any disease or condition, which the Investigator feels, would interfere with the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
HbA1c	after 12 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Blood glucose profiles
Incidence of hypoglycaemic episodes
Incidence of adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; Novi Sad, Former Serbia and Montenegro

Novo Nordisk Investigational Site

Novi Sad, Former Serbia and Montenegro