NCT03220425|CompletedPhase 3FDA Drug

Evaluation of the Efficacy and Safety of Insulin Detemir Compared With That of NPH Insulin in Subjects With Type 1 Diabetes.

A Six Month, Multi-centre, Open-label, Parallel Efficacy and Safety Comparison of Insulin Detemir and NPH 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

NN304-1335

Study Type

interventional

Target

752

Locations

10 countries

Sites

Timeline

RegisteredJul 2017

StartedFeb 2001

CompletionNov 2001

Brief Summary

The aim of this trial is to evaluate the efficacy and safety of insulin detemir using the 2400 nmol/mL formulation to optimise dosing in subjects with type 1 diabetes on a basal (once daily)-bolus regimen.

Trial Health

On Track

Trial Health Score

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

Enrollment

752

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Feb 2001

Shorter than P25 for phase_3

Geographic Reach

10 countries

93 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

9 months study duration

Study Start

First participant enrolled

February 1, 2001

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2001

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2001

Completed

15.7 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2017

Completed

5 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed

Last Updated

July 18, 2017

Status Verified

July 1, 2017

Enrollment Period

9 months

First QC Date

July 13, 2017

Last Update Submit

July 17, 2017

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

The change in the level of glycosylated haemoglobin(HbA1c)
From start of treatment visit 2 (week 0) until end of treatment visit 8 (week 26)

Study Arms (2)

Insulin detemir

EXPERIMENTAL

Drug: Insulin detemir

NPH insulin

ACTIVE COMPARATOR

Drug: NPH insulin

Interventions

Insulin detemirDRUG

Insulin detemir

NPH insulinDRUG

NPH insulin

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Signed and dated informed consent obtained before any trial-related activities
Type 1 diabetes diagnosed and classified according to aetiology
Duration of type 1 diabetes equal to or more than 12 months
Glycosylated haemoglobin less than or equal to 12 percent based on analysis from central laboratory
Able and willing to perform self-blood glucose monitoring

You may not qualify if:

Proliferative retinopathy
Total basal insulin dose of more than 100 IU per day
Recurrent major hypoglycaemia - that would interfere with trial participation (as judged by the investigator)
Known unawareness of hypoglycaemia
Previous treatment with insulin detemir

Contact the study team to confirm eligibility.