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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01538511
First Posted: February 24, 2012
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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

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

Enrollment: 59
Actual Study Start Date: June 5, 2006
Study Completion Date: March 13, 2007
Primary Completion Date: March 13, 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

  Eligibility

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01538511


Locations
Japan
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01538511     History of Changes
Other Study ID Numbers: BIASP-1638
First Submitted: February 20, 2012
First Posted: February 24, 2012
Last Update Posted: October 6, 2017
Last Verified: October 2017

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