Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2

• Registration Number: NCT00605020
• 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 an intensified treatment regimen with preprandial insulin aspart and insulin detemir once or twice daily to a more convenient regimen with biphasic insulin aspart 30 twice daily on blood glucose control in subjects with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12-02
• Primary Completion: 2005-03-03
• Study Completion: 2005-03-03
• Study First Submitted: 2008-01-17
• Study First Submitted QC: 2008-01-17
• Study First Posted: 2008-01-30
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-26
• Last Update Posted: 2017-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 719

Inclusion Criteria

• Type 2 diabetes
• Duration of type 2 diabetes for at least 6 months since diagnosis
• Current treatment with one or two oral antidiabetic drugs for at least 3 months or with one or two oral antidiabetic drugs, given for at least 3 months in combination with intermediate or long-acting insulin/insulin analogue once daily
• BMI below 40 kg/m2
• HbA1c between 7-12%
• Able and willing to perform self-monitoring of capillary blood glucose

Exclusion Criteria

• Current antidiabetic treatment with combination of three or more oral antidiabetic drugs
• Previous treatment with short-acting human insulin, short-acting insulin analogue or biphasic insulin/insulin analogue within the last 6 months (7 days or less within the last 6 months is allowed)
• Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
• Known or suspected allergy to trial product or related products
• Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures
• Receipt of any investigational drug within 4 weeks prior to this trial
• Previous participation in this trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c	after 6 months of treatment

Secondary Outcome Measures

Name	Time	Method
Incidence of hypoglycaemic episodes
Adverse events
Difference of HbA1c change between the two groups	after 13 weeks of treatment
Fasting plasma glucose of treatment	after 13 and 26 weeks
Change in weight

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇨🇭 Zürich, Switzerland