NCT01526980
Completed
Phase 2
A Single-Centre, Randomised, Open-Labelled, Two-Period, Crossover Trial In Subjects With Type 2 Diabetes Comparing the Glycaemic Control of Two Treatment Regimens: A Thrice Daily Regimen With Biphasic Insulin Aspart 70 and - 30 and a Twice Daily Regimen With Biphasic Human Insulin 30
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Glucose average in 24-hour blood glucose profiles
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment period 2
Active Comparator
Intervention: biphasic insulin aspart 70 (Drug)
Treatment period 1
Experimental
Intervention: biphasic insulin aspart 30 (Drug)
Treatment period 1
Experimental
Intervention: biphasic insulin aspart 70 (Drug)
Treatment period 1
Experimental
Intervention: biphasic human insulin 30 (Drug)
Treatment period 2
Active Comparator
Intervention: biphasic insulin aspart 30 (Drug)
Treatment period 2
Active Comparator
Intervention: biphasic human insulin 30 (Drug)
Outcomes
Primary Outcomes
Glucose average in 24-hour blood glucose profiles
Secondary Outcomes
- tmax, time of maximum concentration of total insulin
- The area under the 24-hour total insulin concentration time curve
- Post-meal excursion of glucose (0-4 hours)
- Pre-meal glucose level
- Adverse events
- Cmax, maximum concentration of total insulin
Investigators
Study Sites (1)
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