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

Phase 3

Completed

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

• Registration Number: NCT01697657
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-09
• Primary Completion: 2002-11
• Study Completion: 2002-11
• Study First Submitted: 2012-09-28
• Study First Submitted QC: 2012-09-28
• Study First Posted: 2012-10-02
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-26
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NPH	insulin NPH	-
Detemir	insulin detemir	-
Detemir	insulin aspart	-
NPH	insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Incidence of total self-recorded hypoglycaemic episodes

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇪 Trelleborg, Sweden