Safety and Efficacy of Insulin Aspart in Subjects With Type 1 Diabetes

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1
• Interventions: Drug: insulin aspart; Drug: human soluble insulin; Drug: insulin NPH

• Registration Number: NCT01707134
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to evaluate the safety profile of insulin aspart in subjects with type 1 diabetes having participated in trial ANA/DCD/035.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-09
• Primary Completion: 2000-05
• Study Completion: 2000-05
• Study First Submitted: 2012-10-10
• Study First Submitted QC: 2012-10-15
• Study First Posted: 2012-10-16
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-03
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 753

Inclusion Criteria

• The subject must have completed the six month controlled treatment period in trial ANA/DCD/035

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
insulin aspart	insulin NPH	-
insulin aspart	insulin aspart	-
human insulin	human soluble insulin	-
human insulin	insulin NPH	-

Primary Outcome Measures

Name	Time	Method
Number of hypoglycaemic events

Secondary Outcome Measures

Name	Time	Method
Occurrence of adverse events
Incidence of hypoglycaemic episodes
Standard safety parameters: Haematology and biochemistry
HbA1c (glycosylated haemoglobin)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 York, United Kingdom