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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:
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

February 20, 2012
February 20, 2012
June 2006
March 2007   (final data collection date for primary outcome measure)
Area under the plasma insulin concentration curve from 0 to 24 hours [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Insulin Profile of Biphasic Insulin Aspart 70 to That of Biphasic Insulin Aspart 30 in Healthy Volunteers
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • 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
  • 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
  • Drug: No treatment given
    Control group of non-treated healthy volunteers
  • Experimental: BIAsp 70
    Intervention: Drug: biphasic insulin aspart 70
  • Experimental: BIAsp 30
    Intervention: Drug: biphasic insulin aspart 30
  • No Intervention: Healty
    Intervention: Drug: No treatment given
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
March 2007
March 2007   (final data collection date for primary outcome measure)

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
Both
20 Years to 69 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01538511
BIASP-1638
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Tomio Sasaki Novo Nordisk Pharma Ltd
Novo Nordisk A/S
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP