Human Insulin NPH and Insulin Aspart in Type 1 Diabetes

December 20, 2016 updated by: Novo Nordisk A/S

Comparative Evaluation of Human NPH Insulin + Insulin Aspart and Human NPH Insulin + Human Soluble Insulin in Type 1 Diabetes Mellitus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Junin, Argentina
    - Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Type 1 diabetes for at least 12 months
Treatment with insulin NPH
Body Mass Index (BMI) below 30 kg/m2

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prandial blood glucose lowering profile Time Frame: between 1st and 2nd post prandial hours	between 1st and 2nd post prandial hours

Secondary Outcome Measures

Outcome Measure
Adverse events
Serious adverse events
Hypoglycaemic events

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Helpful Links

Clinical Trials at Novo Nordisk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

December 1, 2002

Study Completion (Actual)