Basal Bolus of Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes

• Registration Number: NCT00600626
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe and Asia. The aim of this trial is to compare basal bolus treatment with insulin aspart and insulin NPH to biphasic insulin aspart treatment on blood glucose control in type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2004-07
• Study Completion: 2004-07
• 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: 394

Inclusion Criteria

• Type 2 diabetes
• Currently treated with human insulin or insulin analogues for at least 3 months, with or without combination with OADs
• HbA1c between 8.0-10.5%
• Body mass index (BMI) below 35.0 kg/m2
• Able and willing to perform self-monitoring of blood glucose

Exclusion Criteria

• Total daily insulin dose of 1.80 IU/kg or more
• Known or suspected allergy to trial product or related products
• Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c	after 4 months of treatment

Secondary Outcome Measures

Name	Time	Method
safety profiles
changes in body weight and vital signs
8-point blood glucose profile
incidence of hypoglycaemic episodes

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 York, United Kingdom