NCT01526941

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare the single dose and steady state pharmacodynamics of biphasic insulin aspart 30 and biphasic insulin aspart 70 in subjects with type 1 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 diabetes

Timeline
Completed

Started May 2001

Shorter than P25 for phase_1 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, 2001

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2001

Completed
10.6 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

2 months

First QC Date

February 1, 2012

Last Update Submit

January 4, 2017

Conditions

DiabetesDiabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • Steady state area under the glucose infusion rate profile, 6-12 hours

Secondary Outcomes (9)

  • GIRmax, the maximal glucose infusion rate value

  • tmax, time to maximum glucose infusion rate value

  • area under the glucose infusion rate profile

  • Time to 50% of area under the glucose infusion rate profile, 0-12 hours

  • Cmax, maximum concentration

  • +4 more secondary outcomes

Study Arms (2)

Treatment period 1

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

Treatment period 2

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

Interventions

biphasic insulin aspart 30DRUG

Dose individually adjusted. Administered subcutaneously (s.c., under the skin) three times a day for 1 week in each treatment period. A wash-out period of 2-6 weeks will take place between treatment periods

Treatment period 1Treatment period 2
biphasic insulin aspart 70DRUG

Dose individually adjusted. Administered subcutaneously (s.c., under the skin) three times a day for 1 week in each treatment period. A wash-out period of 2-6 weeks will take place between treatment periods

Treatment period 1Treatment period 2

Eligibility Criteria

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

You may qualify if:

  • Type 1 diabetes for at least 12 months
  • Currently on basal bolus treatment with soluble human insulin, Lispro and NPH insulin or Lantus. NPH insulin may be administered once or twice daily
  • BMI (Body Mass Index) maximum 35 kg/m\^2
  • Able and willing to perform self-blood glucose monitoring

You may not qualify if:

  • The receipt of any investigational drug within the last 30 days prior to this trial
  • Total daily insulin dose at least 1.8 U/kg/day
  • Currently being treated with insulin aspart products
  • A history of drug abuse or alcohol dependence within the last 5 years
  • Impaired hepatic function
  • Impaired renal function
  • Blood donation (exceeding 500 ml) within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory
  • Cardiac problems
  • Severe, uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

Related Publications (1)

  • Bott S, Tusek C, Heinemann L, Friberg HH, Heise T. The pharmacokinetic and pharmacodynamic properties of biphasic insulin Aspart 70 (BIAsp 70) are significantly different from those of biphasic insulin Aspart 30 (BIAsp 30). Exp Clin Endocrinol Diabetes. 2005 Oct;113(9):545-50. doi: 10.1055/s-2005-872852.

    PMID: 16235159RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Global Clinical Registry (GCR,1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
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, 2001

Primary Completion

July 1, 2001

Study Completion

July 1, 2001

Last Updated

January 5, 2017

Record last verified: 2017-01

Locations

DE(1)