NCT01486940|CompletedPhase 3

Comparison of Insulin Detemir Plus Insulin Aspart With Insulin NPH Plus Human Soluble Insulin in Subjects With Type 1 Diabetes

A Multi-centre, Multinational, Open-labelled, Randomised, Parallel-Group Comparison of Insulin Detemir Plus Insulin Aspart With NPH Insulin Plus Human Soluble Insulin in Subjects With Type 1 Diabetes on a Basal-Bolus Regimen

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

NN304-1374

Study Type

interventional

Target

598

Locations

14 countries

Sites

Timeline

RegisteredDec 2011

StartedMar 2002

CompletionOct 2002

Brief Summary

This trial is conducted in Europe and South America. The aim of this trial is to compare the glycaemic control of insulin detemir plus insulin aspart with that of insulin NPH plus human soluble insulin in subjects with type 1 diabetes on a basal/bolus regimen.

Trial Health

On Track

Trial Health Score

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

Enrollment

598

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Mar 2002

Shorter than P25 for phase_3 diabetes

Geographic Reach

14 countries

74 active sites

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

7 months study duration

Study Start

First participant enrolled

March 1, 2002

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2002

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2002

Completed

9.2 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2011

Completed

2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed

Last Updated

January 27, 2017

Status Verified

January 1, 2017

Enrollment Period

7 months

First QC Date

December 5, 2011

Last Update Submit

January 26, 2017

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

HbA1c (glycosylated haemoglobin)

Secondary Outcomes (4)

Intra-subject variation in home measured blood glucose (3-point blood glucose profiles)
8-point blood glucose profiles
Incidence of self-recorded hypoglycaemic episodes
Incidence of adverse events

Study Arms (2)

Basal/bolus regimen 1

EXPERIMENTAL

Drug: insulin detemirDrug: insulin aspart

Basal/bolus regimen 2

ACTIVE COMPARATOR

Drug: insulin NPHDrug: human soluble insulin

Interventions

insulin detemirDRUG

Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily

Basal/bolus regimen 1

insulin aspartDRUG

Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals

Basal/bolus regimen 1

insulin NPHDRUG

Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily

Basal/bolus regimen 2

human soluble insulinDRUG

Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals

Basal/bolus regimen 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
Current treatment with any basal/bolus regimen or any biphasic insulin treatment for at least 6 months
BMI below or equal to 35 kg/m\^2
HbA1c below or equal to 12%

You may not qualify if:

Proliferative retinopathy or maculopathy requiring acute treatment
Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the Investigator)
Subjects with known hypoglycaemic unawareness as judged by the Investigator

Contact the study team to confirm eligibility.