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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01697657

Enrollment

131

Registered

2012-10-02

Start date

2001-09-30

Completion date

2002-11-30

Last updated

2017-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 1

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.

Interventions

DRUGinsulin detemir

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

DRUGinsulin NPH

DRUGinsulin aspart

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Incidence of total self-recorded hypoglycaemic episodes	—

Secondary

Measure	Time frame
HbA1c (glycosylated haemoglobin)	—
8-point plasma glucose profiles	—
Serum glucose profiles	—
Incidence of total major hypoglycaemic episodes	—
Within-subject variation in home-measured fasting plasma glucose	—
Incidence of adverse events	—
72-hours glucose profile	—

Countries

Australia, Croatia, Denmark, Italy, South Africa, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026