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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01538511
First received: February 20, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart 70
Drug: biphasic insulin aspart 30
Drug: No treatment given
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the plasma insulin concentration curve from 0 to 24 hours [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the concentration curve of plasma insulin from 0 to 4 hours after meals [ Designated as safety issue: No ]
  • Maximum plasma insulin concentration observed from 0 to 4 hours after meals [ Designated as safety issue: No ]
  • Time to reach the maximum plasma insulin concentration from 0 to 4 hours after meals [ Designated as safety issue: No ]
  • The 24-hour plasma insulin profile deviances in Japanese type 2 diabetic subjects [ Designated as safety issue: No ]
  • Pre-meal plasma glucose concentration before meals [ Designated as safety issue: No ]
  • Postprandial plasma glucose (PPPG) excursion from 0 to 4 hours after meals [ Designated as safety issue: No ]
  • The maximum plasma glucose concentration observed from 0 to 4 hours after meals [ Designated as safety issue: No ]
  • The time to reach the maximum plasma glucose concentration of observed from 0 to 4 hours after meals [ Designated as safety issue: No ]
  • Average of plasma glucose concentration from 0 to 24 hours [ Designated as safety issue: No ]
  • The area under the plasma C-peptide concentration curve from 0 to 24 hours derived from the 24-hour plasma C-peptide profile [ Designated as safety issue: No ]
  • Frequency of hypoglycaemic episodes [ Designated as safety issue: No ]
  • Frequency of adverse events [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: June 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIAsp 70 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
Experimental: BIAsp 30 Drug: biphasic insulin aspart 30
Administered subcutaneously (s.c., under the skin) twice daily immediately before breakfast and dinner for 4 weeks. Dose individually adjusted
No Intervention: Healty Drug: No treatment given
Control group of non-treated healthy volunteers

  Eligibility

Ages Eligible for Study:   20 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01538511

Locations
Japan
Tokyo, Japan, 103
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Tomio Sasaki Novo Nordisk Pharma Ltd
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01538511     History of Changes
Other Study ID Numbers: BIASP-1638
Study First Received: February 20, 2012
Last Updated: February 20, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Biphasic Insulins
Insulin
Insulin Aspart
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin, Globin Zinc
Insulin, Isophane
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014