Comparison of Two Biphasic Insulin Aspart Treatments in Subjects With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Randomised, Double-blind, 4-week, Crossover Trial on Two Treatment Regimens With Biphasic Insulin Aspart 70 and 50 in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01520753
• Other study ID #: BIASP-1074
• Status: Completed
• Phase: Phase 3
• First received: January 25, 2012
• Last updated: January 3, 2017
• Start date: March 1999
• Est. completion date: June 1999

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 two different active treatment regimens of biphasic insulin aspart in subjects with type 2 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 1999
• Est. primary completion date: June 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Type 2 diabetes

• Duration of diabetes for longer than 12 months

• Body mass index (BMI) below 35.0 kg/m^2

• HbA1c below 11.0 %

• Treatment with BHI (biphasic human insulin) 20 or 30 twice daily for at least three months and in the last month as sole anti-diabetic treatment (i.e., no additional oral hypoglycaemic medication or daily use of short-acting insulin supplement)

Exclusion Criteria:

• Current treatment with agents affecting glucose metabolism

• History of drug or alcohol dependence

• Impaired hepatic function

• Impaired renal function

• Cardiac disease

• Proliferative retinopathy

• Recurrent severe hypoglycaemia or advanced neuropathy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy 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 70
Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner
• biphasic insulin aspart 70
Administered subcutaneously (s.c., under the skin) at breakfast and lunch
• biphasic insulin aspart 50
Administered subcutaneously (s.c., under the skin) at dinner

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)

Ejskjaer N, Rasmussen M, Kamp N, Lindholm A, Christiansen JS. Comparison of thrice daily 'high' vs. 'medium' premixed insulin aspart with respect to evening and overnight glycaemic control in patients with type 2 diabetes. Diabetes Obes Metab. 2003 Nov;5( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting serum glucose			No
Secondary	24-hour serum glucose profiles			No
Secondary	24-hour insulin profiles			No
Secondary	Incidence of hypoglycaemic episodes			No
Secondary	Incidence of adverse events			No

External Links

•   Clinical Trials at Novo Nordisk