Comparison of Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 50 to Biphasic Insulin Aspart 70 in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Comparison of the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 50 to Biphasic Insulin Aspart 70 in Non-obese and Obese With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00612599
• Other study ID #: BIASP-1526
• Status: Completed
• Phase: Phase 3
• First received: January 28, 2008
• Last updated: January 5, 2017
• Start date: September 2003
• Est. completion date: June 2004

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• biphasic insulin aspart

Locations

Country	Name	City	State
Denmark	Novo Nordisk Investigational Site	Århus C

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

References & 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 diab — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the serum glucose concentration profile during 24 hours		after 4 weeks of treatment	No
Secondary	Pharmacodynamics properties			No
Secondary	Pharmacokinetic properties			No
Secondary	8-point self-monitored blood glucose profiles			No
Secondary	Adverse events			No
Secondary	Hypoglycaemic episodes			No

External Links

•   Clinical Trials at Novo Nordisk