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Clinical Trials/NCT01520753
NCT01520753
Completed
Phase 3

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

Novo Nordisk A/S1 site in 1 country16 target enrollmentMarch 1999

Overview

Phase
Phase 3
Intervention
biphasic insulin aspart 50
Conditions
Diabetes
Sponsor
Novo Nordisk A/S
Enrollment
16
Locations
1
Primary Endpoint
Fasting serum glucose
Status
Completed
Last Updated
9 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
March 1999
End Date
June 1999
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

BIAsp 70 + BIAsp 50

Intervention: biphasic insulin aspart 50

BIAsp 70

Intervention: biphasic insulin aspart 70

BIAsp 70 + BIAsp 50

Intervention: biphasic insulin aspart 70

Outcomes

Primary Outcomes

Fasting serum glucose

Secondary Outcomes

  • 24-hour serum glucose profiles
  • Incidence of hypoglycaemic episodes
  • 24-hour insulin profiles
  • Incidence of adverse events

Study Sites (1)

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