Insulin Profile of Biphasic Insulin Aspart 70 to That of Biphasic Insulin Aspart 30 in Healthy Volunteers
NCT ID: NCT01538511
Last Updated: 2017-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
59 participants
INTERVENTIONAL
2006-06-05
2007-03-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BIAsp 70
biphasic insulin aspart 70
Administered subcutaneously (s.c., under the skin) three times daily immediately before breakfast, lunch and dinner for 4 weeks. Dose individually adjusted
BIAsp 30
biphasic insulin aspart 30
Administered subcutaneously (s.c., under the skin) twice daily immediately before breakfast and dinner for 4 weeks. Dose individually adjusted
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
biphasic insulin aspart 70
Administered subcutaneously (s.c., under the skin) three times daily immediately before breakfast, lunch and dinner for 4 weeks. Dose individually adjusted
biphasic insulin aspart 30
Administered subcutaneously (s.c., under the skin) twice daily immediately before breakfast and dinner for 4 weeks. Dose individually adjusted
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects with type 2 diabetes mellitus
* Current treatment using intermediate-acting, long-acting or pre-mixed/biphasic insulin preparation (including insulin analogues) in once or twice daily (before breakfast and dinner) treatment regimen for at least 12 weeks (a temporary use \[maximum of one week in total\] of rapid-acting human insulin will be allowed)
* Age between 20-69 years, both inclusive
* HbA1c (glycosylated haemoglobin A1c) below 9.0%
* Body Mass Index (BMI) 18.5-25.0 kg/m\^2
* Total daily insulin dose (per day) above 0.2 U or IU/kg body weight and below 1.0 U or IU/kg body weight HEALTHY VOLUNTEERS
* Japanese subjects with considered generally healthy based on medical history and physical examination
* Age between 20-29 years, both inclusive
* Body Mass Index (BMI) 18.5-25.0 kg/m\^2
* Subjects with normal glucose tolerance (NGT); defined as fasting plasma glucose below 110 mg/dL and 2-hour post OGTT (oral glucose tolerance test) plasma glucose below 140 mg/dL
Exclusion Criteria
* Proliferative retinopathy or maculopathy requiring acute treatment
* Impaired hepatic function
* Impaired renal function
* Serious cardiac diseases
* Uncontrolled hypertension
* Known hypoglycaemia unawareness or recurrent major hypoglycaemia
* Current treatment or expected at the screening to start treatment with systemic corticosteroids HEALTHY VOLUNTEERS
* Any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) at the screening
* History or presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
* Subjects with a first-degree relative with diabetes mellitus
20 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novo Nordisk A/S
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novo Nordisk Investigational Site
Tokyo, , Japan
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Clinical Trials at Novo Nordisk
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BIASP-1638
Identifier Type: -
Identifier Source: org_study_id