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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00612599
• Date of registration: 28/01/2008
• Prospective Registration: No
• Primary sponsor: Novo Nordisk A/S
• Public title: Comparison of Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 50 to Biphasic Insulin Aspart 70 in Type 2 Diabetes
• Scientific 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
• Date of first enrolment: September 2003
• Target sample size: 75
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00612599
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Denmark

Contacts

• Name: Global Clinical Registry (GCR, 1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

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)



Age minimum: 30 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes

Diabetes Mellitus, Type 2

Intervention(s)

Drug: biphasic insulin aspart

Primary Outcome(s)

Area under the serum glucose concentration profile during 24 hours [Time Frame: after 4 weeks of treatment]

Secondary Outcome(s)

Pharmacokinetic properties

8-point self-monitored blood glucose profiles

Hypoglycaemic episodes

Adverse events

Pharmacodynamics properties

Secondary ID(s)

BIASP-1526

Source(s) of Monetary Support

Please refer to primary and secondary sponsors