NCT01526980

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control of biphasic insulin aspart 70 + biphasic insulin aspart 30 with biphasic human insulin 30 in subjects with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_2 diabetes

Timeline
Completed

Started May 2002

Shorter than P25 for phase_2 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed
9.3 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2012

Completed
Last Updated

January 5, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

February 1, 2012

Last Update Submit

January 4, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Glucose average in 24-hour blood glucose profiles

Secondary Outcomes (6)

  • Pre-meal glucose level

  • Post-meal excursion of glucose (0-4 hours)

  • Cmax, maximum concentration of total insulin

  • tmax, time of maximum concentration of total insulin

  • The area under the 24-hour total insulin concentration time curve

  • +1 more secondary outcomes

Study Arms (2)

Treatment period 1

EXPERIMENTAL
Drug: biphasic insulin aspart 30Drug: biphasic insulin aspart 70Drug: biphasic human insulin 30

Treatment period 2

ACTIVE COMPARATOR
Drug: biphasic insulin aspart 30Drug: biphasic insulin aspart 70Drug: biphasic human insulin 30

Interventions

biphasic insulin aspart 30DRUG

Administrated subcutaneously (s.c., under the skin) once daily before dinner for 30 days in each treatment period

Treatment period 1Treatment period 2
biphasic insulin aspart 70DRUG

Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and lunch for 30 days in each treatment period

Treatment period 1Treatment period 2
biphasic human insulin 30DRUG

Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and dinner for 30 days in each treatment period

Treatment period 1Treatment period 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with Type 2 diabetes
  • Treatment with BHI (biphasic human insulin) 30 twice daily for at least three months
  • HbA1c maximum 10.0%
  • BMI (Body Mass Index) maximum 35.0 kg/m2
  • Able and willing to perform self-blood glucose monitoring (SBGM)

You may not qualify if:

  • The receipt of any investigational drug within the last 30 days prior to this trial
  • Total daily insulin dose minimum 2.0 U/(kg·day)
  • A history of drug abuse or alcohol dependence within the last 5 years
  • Impaired hepatic function
  • Impaired renal function
  • Cardiac disease
  • Severe, uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Newcastle, United Kingdom

Location

Related Publications (1)

  • Dashora U, Ashwell SG, Home PD. An exploratory study of the effect of using high-mix biphasic insulin aspart in people with type 2 diabetes. Diabetes Obes Metab. 2009 Jul;11(7):680-7. doi: 10.1111/j.1463-1326.2008.01024.x.

    PMID: 19527481RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70biphasic human insulin 30

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Global Clinical Registry (GCR,1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2012

First Posted

February 6, 2012

Study Start

May 1, 2002

Primary Completion

November 1, 2002

Study Completion

November 1, 2002

Last Updated

January 5, 2017

Record last verified: 2017-01

Locations

GB(1)