Efficacy and Safety of a Fixed or a Flexible Supplementary Insulin Therapy in Type 2 Diabetes

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes

• Registration Number: NCT00274274
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. This trial aims for a comparison of the efficacy and safety of Insulin Aspart, given in a fixed or in a flexible supplementary insulin therapy, with or without Insulin Detemir plus Metformin, if needed, in subjects with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2006-01-09
• Study First Submitted QC: 2006-01-09
• Study First Posted: 2006-01-10
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-20
• Last Update Posted: 2014-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 373

Inclusion Criteria

• Type 2 Diabetes for more than 6 months
• Treatment with 1 or more oral anti-diabetic drugs or insulin, or a combination of these for more than 3 months
• Body Mass Index (BMI) less than or equal to 40 kg/m2
• HbA1c 7.0-11.0%

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Exclusion Criteria

• Treatment with short acting insulin(s) for longer than 10 days
• Current treatment with TZDs. A TZD medication must be stopped at least 14 days before the randomization
• Proliferative retinopathy or maculopathy requiring acute or laser treatment within the last 6 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c	after 52 weeks

Secondary Outcome Measures

Name	Time	Method
Quality of Life
Safety parameters
Frequency of BG measurements
Duration of education
Blood glucose profiles
Percentage of patients with HbA1c less than 7.0% after 52 weeks