NCT01697657|CompletedPhase 3

Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir in Well Controlled Subjects With Type 1 Diabetes

A Randomised, Open Label, Cross-over, Multi-centre, Multinational Trial Comparing the Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir and NPH Insulin in Well Controlled Subjects With Type 1 Diabetes on a Basal-bolus Regimen

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

NN304-1375

Study Type

interventional

Target

131

Locations

6 countries

Sites

Timeline

RegisteredOct 2012

StartedSep 2001

CompletionNov 2002

Brief Summary

This trial is conducted in Africa, Europe and Oceania. The aim of this trial is to investigate whether insulin detemir combined with insulin aspart compared to NPH insulin combined with insulin aspart could reduce the frequency of hypoglycaemic episodes whilst maintaining the same degree of glycaemic control subjects with type 1 diabetes.

Trial Health

On Track

Trial Health Score

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

Enrollment

131

participants targeted

Target at below P25 for phase_3 diabetes

Timeline

Completed

Started Sep 2001

Geographic Reach

6 countries

11 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

1.2 years study duration

Study Start

First participant enrolled

September 1, 2001

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2002

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed

9.9 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

October 2, 2012

Completed

Last Updated

January 27, 2017

Status Verified

January 1, 2017

Enrollment Period

1.2 years

First QC Date

September 28, 2012

Last Update Submit

January 26, 2017

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

Incidence of total self-recorded hypoglycaemic episodes

Secondary Outcomes (7)

Incidence of total major hypoglycaemic episodes
HbA1c (glycosylated haemoglobin)
8-point plasma glucose profiles
Serum glucose profiles
72-hours glucose profile
+2 more secondary outcomes

Study Arms (2)

Detemir

EXPERIMENTAL

Drug: insulin detemirDrug: insulin aspart

NPH

ACTIVE COMPARATOR

Drug: insulin NPHDrug: insulin aspart

Interventions

insulin detemirDRUG

Subjects were dosed according to individual requirements. Injected subcutaneously (s.c. under the skin) twice daily in the morning and at bedtime for 10 weeks after an initial 6-week titration in treatment period 1 followed by 10 weeks after an initial 6-week titration in treatment period 2

Detemir

insulin NPHDRUG

NPH

insulin aspartDRUG

Subjects were dosed according to individual requirements. Injected subcutaneously (s.c. under the skin) twice daily before meals for 10 weeks after an initial 6-week titration in treatment period 1 followed by 10 weeks after an initial 6-week titration in treatment period 2

DetemirNPH

Eligibility Criteria

Age18 Years - 100 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 1 diabetes
Fasting c-peptide below lower limit of normal fasting range
Duration of type 1 diabetes for at least 12 months
Current treatment: Basal - bolus regimen for at least 4 months with intermediate or long-acting insulin once, twice or three times daily as basal insulin and 3-4 premeal insulin aspart or lispro injections
HbA1c maximum 9.0% (using Biorad Variant method)
Able and willing to perform self-monitoring of blood glucose
Basal insulin requirement at least 30% of the total daily insulin dose
BMI (body Mass Index) maximum 35 kg/m\^2

You may not qualify if:

Proliferative retinopathy or maculopathy requiring acute treatment
Total daily insulin dose above 1.4 IU/kg/day
Known unawareness of hypoglycaemia
Impaired hepatic function
Impaired renal function
Cardiac problems
Uncontrolled, treated/untreated hypertension
Known or suspected allergy to trial product or related products

Contact the study team to confirm eligibility.