NCT00612599

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 50 three times a day to biphasic insulin aspart 70 three times a day in non-obese and obese with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at below P25 for phase_3 diabetes

Timeline
Completed

Started Sep 2003

Shorter than P25 for phase_3 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 11, 2008

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

9 months

First QC Date

January 28, 2008

Last Update Submit

January 5, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Area under the serum glucose concentration profile during 24 hours

    after 4 weeks of treatment

Secondary Outcomes (5)

  • Pharmacodynamics properties

  • Pharmacokinetic properties

  • 8-point self-monitored blood glucose profiles

  • Adverse events

  • Hypoglycaemic episodes

Interventions

biphasic insulin aspartDRUG
Also known as: BIASP

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes for at least 12 months
  • Stable glycaemic control, having been on the existing treatment for at least 1 month
  • BMI between 23-28 kg/m2 (non-obese) or between 30-35 kg/m2 (obese)
  • HbA1c below 9.0%
  • Willing to eat three main meals per day during the trial period and perform Self-Monitoring of Blood Glucose (SBGM) regularly

You may not qualify if:

  • A history of drug abuse or alcohol dependence
  • Blood donation within the last 3 months
  • Currently being treated with systemic corticosteroids, Mono Amine Oxidase (MAO) inhibitors, beta-adrenergic blocking agents, anabolic steroids or any other drug affecting blood glucose
  • Severe, uncontrolled hypertension
  • Proliferative retinopathy or maculopathy requiring acute treatment
  • Pregnancy, breast-feeding, intention of becoming pregnant or judged not to be using adequate contraceptive measures (for women of childbearing potential only contraceptive pills and intra uterine devices are considered as adequate contraceptive methods)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Århus C, 8000, Denmark

Location

Related Publications (1)

  • Parkner T, Dyrskog SE, Laursen T, Chen JW, Mouritzen U, Brondsted L, Hermansen K, Lauritzen T, Christiansen JS. Obesity does not influence the unique pharmacological properties of different biphasic insulin aspart preparations in patients with type 2 diabetes. Diabetes Obes Metab. 2010 May;12(5):414-20. doi: 10.1111/j.1463-1326.2009.01178.x.

    PMID: 20415689RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2008

First Posted

February 11, 2008

Study Start

September 1, 2003

Primary Completion

June 1, 2004

Study Completion

June 1, 2004

Last Updated

January 6, 2017

Record last verified: 2017-01

Locations

DK(1)