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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
biphasic insulin aspart 70
biphasic insulin aspart 70
biphasic insulin aspart 50
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

BIAsp 70

BIAsp 70 + BIAsp 50

Arm Description

Outcomes

Primary Outcome Measures

Fasting serum glucose

Secondary Outcome Measures

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

Full Information

First Posted
January 25, 2012
Last Updated
January 3, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01520753
Brief Title
Comparison of Two Biphasic Insulin Aspart Treatments in Subjects With Type 2 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
June 1999 (Actual)
Study Completion Date
June 1999 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIAsp 70
Arm Type
Experimental
Arm Title
BIAsp 70 + BIAsp 50
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart 70
Intervention Description
Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart 70
Intervention Description
Administered subcutaneously (s.c., under the skin) at breakfast and lunch
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart 50
Intervention Description
Administered subcutaneously (s.c., under the skin) at dinner
Primary Outcome Measure Information:
Title
Fasting serum glucose
Secondary Outcome Measure Information:
Title
24-hour serum glucose profiles
Title
24-hour insulin profiles
Title
Incidence of hypoglycaemic episodes
Title
Incidence of adverse events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR,1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Århus C
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
14617230
Citation
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(6):438-45. doi: 10.1046/j.1463-1326.2003.00299.x.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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