Human Insulin NPH and Insulin Aspart in Type 1 Diabetes

Phase 4

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1

• Registration Number: NCT00597233
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Primary Completion: 2002-12
• Study Completion: 2002-12
• Study First Submitted: 2008-01-09
• Study First Submitted QC: 2008-01-09
• Study First Posted: 2008-01-18
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-20
• Last Update Posted: 2016-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Prandial blood glucose lowering profile	between 1st and 2nd post prandial hours

Secondary Outcome Measures

Name	Time	Method
Adverse events
Serious adverse events
Hypoglycaemic events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇦🇷 Junin, Argentina