Insulin Profile of Biphasic Insulin Aspart 70 to That of Biphasic Insulin Aspart 30 in Healthy Volunteers

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Two-centre, Randomised, Open-labelled, Four-week, Parallel-group Pharmacokinetics Trial in Japanese Type 2 Diabetic Subjects Characterising the Insulin Profile of Thrice Daily Regimen With Biphasic Insulin Aspart 70 (NN2000-Mix70) With Reference to That of Twice Daily Regimen With Biphasic Insulin Aspart 30 (NN-X14Mix30) and Physiological Insulin Profile in Japanese Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01538511
• Other study ID #: BIASP-1638
• Status: Completed
• Phase: Phase 1
• First received: February 20, 2012
• Last updated: October 4, 2017
• Start date: June 5, 2006
• Est. completion date: March 13, 2007

Study information

• Verified date: October 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Japan. The aim of this trial is to compare biphasic insulin aspart 70 (NN2000-Mix70) in subjects with type 2 diabetes with that of biphasic insulin aspart 30 (NN-X14Mix30) in healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 13, 2007
• Est. primary completion date: March 13, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

SUBJECTS WITH TYPE 2 DIABETES

• 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:

SUBJECTS WITH TYPE 2 DIABETES

• 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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma insulin concentration curve from 0 to 24 hours
Secondary	Area under the concentration curve of plasma insulin from 0 to 4 hours after meals
Secondary	Maximum plasma insulin concentration observed from 0 to 4 hours after meals
Secondary	Time to reach the maximum plasma insulin concentration from 0 to 4 hours after meals
Secondary	The 24-hour plasma insulin profile deviances in Japanese type 2 diabetic subjects
Secondary	Pre-meal plasma glucose concentration before meals
Secondary	Postprandial plasma glucose (PPPG) excursion from 0 to 4 hours after meals
Secondary	The maximum plasma glucose concentration observed from 0 to 4 hours after meals
Secondary	The time to reach the maximum plasma glucose concentration of observed from 0 to 4 hours after meals
Secondary	Average of plasma glucose concentration from 0 to 24 hours
Secondary	The area under the plasma C-peptide concentration curve from 0 to 24 hours derived from the 24-hour plasma C-peptide profile
Secondary	Frequency of hypoglycaemic episodes
Secondary	Frequency of adverse events

External Links

•   Clinical Trials at Novo Nordisk