Glycaemic Control of Biphasic Insulin Aspart 70 and 30 in Subjects With Type 2 Diabetes

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Interventions: Drug: biphasic insulin aspart 30; Drug: biphasic insulin aspart 70; Drug: biphasic human insulin 30

• Registration Number: NCT01526980
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control of biphasic insulin aspart 70 + biphasic insulin aspart 30 with biphasic human insulin 30 in subjects with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05
• Primary Completion: 2002-11
• Study Completion: 2002-11
• Study First Submitted: 2012-02-01
• Study First Submitted QC: 2012-02-01
• Study First Posted: 2012-02-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-04
• Last Update Posted: 2017-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Subjects with Type 2 diabetes
• Treatment with BHI (biphasic human insulin) 30 twice daily for at least three months
• HbA1c maximum 10.0%
• BMI (Body Mass Index) maximum 35.0 kg/m2
• Able and willing to perform self-blood glucose monitoring (SBGM)

Exclusion Criteria

• The receipt of any investigational drug within the last 30 days prior to this trial
• Total daily insulin dose minimum 2.0 U/(kg·day)
• A history of drug abuse or alcohol dependence within the last 5 years
• Impaired hepatic function
• Impaired renal function
• Cardiac disease
• Severe, uncontrolled hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment period 2	biphasic insulin aspart 30	-
Treatment period 2	biphasic insulin aspart 70	-
Treatment period 1	biphasic insulin aspart 30	-
Treatment period 1	biphasic human insulin 30	-
Treatment period 2	biphasic human insulin 30	-
Treatment period 1	biphasic insulin aspart 70	-

Primary Outcome Measures

Name	Time	Method
Glucose average in 24-hour blood glucose profiles

Secondary Outcome Measures

Name	Time	Method
tmax, time of maximum concentration of total insulin
Post-meal excursion of glucose (0-4 hours)
Pre-meal glucose level
Adverse events
Cmax, maximum concentration of total insulin
The area under the 24-hour total insulin concentration time curve

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Newcastle, United Kingdom