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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Efficacy and Safety of Insulin Aspart in a Fixed or Flexible Supplementary Insulin Therapy Regimen, With or Without Insulin Detemir in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00274274
• Other study ID #: NN304-1657
• Secondary ID: 2005-000319-87
• Status: Completed
• Phase: Phase 4
• First received: January 9, 2006
• Last updated: November 20, 2014
• Start date: September 2005
• Est. completion date: November 2006

Study information

• Verified date: November 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 373
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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%

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin detemir

• insulin aspart

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		after 52 weeks	No
Secondary	Blood glucose profiles			No
Secondary	Percentage of patients with HbA1c less than 7.0% after 52 weeks			No
Secondary	Quality of Life			No
Secondary	Frequency of BG measurements			No
Secondary	Safety parameters			No
Secondary	Duration of education			No

External Links

•   Clinical Trials at Novo Nordisk