Efficacy and Safety of NovoMix® 30 in Subjects With Type 2 Diabetes

Phase 4

Completed

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

• Registration Number: NCT01467401
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart (NovoMix®30) to that of biphasic human insulin (Mixtard® 30) in subjects with type 2 diabetes.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2002-08-19
• Primary Completion: 2003-05-15
• Study Completion: 2003-05-15
• Study First Submitted: 2011-11-04
• Study First Submitted QC: 2011-11-04
• Study First Posted: 2011-11-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 292

Inclusion Criteria

• Type 2 diabetes for at least 24 months
• Insulin treatment for the pase 3 months
• HbA1c (glycosylated haemoglobin) below 13%
• BMI (Body Mass Index) below 40 kg/m^2
• Ability and willingness to perform self-blood glucose monitoring

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Exclusion Criteria

• Receipt of any investigational drug within 4 weeks prior to this trial
• Treatment of OHAs (Oral Hypoglycaemic Agents) within 4 weeks prior to this trial
• Total daily insulin dosage less than or equal to 1.8 IU/kg

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	biphasic insulin aspart	-
B	biphasic human insulin	-

Primary Outcome Measures

Name	Time	Method
HbA1c (glycolated haemoglobin)

Secondary Outcome Measures

Name	Time	Method
7-point blood glucose profile
Number and severity of local tolerability issues at the injection site
Number and severity of hypoglycaemic episodes
Prandial increment in blood glucose
Number and severity of adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇪 Östersund, Sweden