NCT00597233

Brief Summary

This trial is conducted in South America. This aim of this trial is to evaluate the comparative prandial blood glucose lowering profile 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
91

participants targeted

Target at P25-P50 for phase_4 diabetes

Timeline
Completed

Started Oct 2002

Shorter than P25 for phase_4 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

October 1, 2002

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2008

Completed
Last Updated

December 22, 2016

Status Verified

December 1, 2016

Enrollment Period

2 months

First QC Date

January 9, 2008

Last Update Submit

December 20, 2016

Conditions

DiabetesDiabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • Prandial blood glucose lowering profile

    between 1st and 2nd post prandial hours

Secondary Outcomes (3)

  • Hypoglycaemic events

  • Adverse events

  • Serious adverse events

Interventions

insulin aspartDRUG
soluble human insulinDRUG
insulin NPHDRUG

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
  • Treatment with insulin NPH
  • Body Mass Index (BMI) below 30 kg/m2

You may not qualify if:

  • Total daily insulin dose greater than 1.40 IU/kg
  • Treatment with oral antidiabetic drugs (OADs)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Junín, Argentina

Location

Related Publications (1)

  • Cintora H, Rodrigues M, Klyver MI, Claus-Hermerg H, González G, Kanevsky D, Medrano G, Sánchez A. Insulina Aspártica versus insulina soluble humana: Estudio comparativo cruzado en pacientes con diabetes tipo 1. Revista de la Sociedad Argentina de Diabetes 2004; 38 (4): 218-224

    RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Interventions

Insulin AspartInsulin, Isophane

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Long-Acting

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2008

First Posted

January 18, 2008

Study Start

October 1, 2002

Primary Completion

December 1, 2002

Study Completion

December 1, 2002

Last Updated

December 22, 2016

Record last verified: 2016-12

Locations

AR(1)