Overview

A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes

Status:
Completed

Trial end date:
2016-01-11

Target enrollment:
0

Participant gender:
All

Summary

This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to compare the safety and efficacy of insulin degludec (IDeg) and insulin glargine (IGlar), both with insulin aspart (IAsp) as mealtime insulin in subjects with type 1 diabetes.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Novo Nordisk A/S

Treatments:

Insulin
Insulin Aspart
Insulin degludec, insulin aspart drug combination
Insulin Glargine
Insulin, Globin Zinc
Insulin, Long-Acting

Criteria

Inclusion Criteria: - Subjects fulfilling at least one of the below criteria: a)
Experienced at least one severe hypo episode within the last year (according to the ADA
(American Diabetes Association) definition, April 2013) b) Moderate chronic renal failure,
defined as glomerular filtration rate 30 - 59 mL/min/1.73 m^2 per CKD-Epi (chronic kidney
disease epidemiology collaboration) c) Hypoglycaemic symptom unawareness d) Diabetes
mellitus duration for more than 15 years e) Recent episode of hypoglycaemia (defined by
symptoms of hypoglycaemia and/or episode with low glucose measurement (below or equal to 70
mg/dL [below or equal to 3.9 mmol/L])) within the last 12 weeks prior to Visit 1
(screening) - Male or female, age at least 18 years at the time of signing informed consent
- Type 1 diabetes mellitus (diagnosed clinically) for at least 52 weeks prior to Visit 1 -
Current treatment with a basal-bolus regimen consisting of neutral protamine Hagedorn (NPH)
insulin OD (once daily) / BID (twice daily) or insulin detemir (IDet) OD / BID plus 2-4
daily injections of any rapid acting meal time insulin or CSII (with rapid acting insulin)
for at least 26 weeks prior to Visit 1 - HbA1c (glycosylated haemoglobin) below or equal to
10% by central laboratory analysis - BMI (body mass index) below or equal to 45 kg/m^2
Exclusion Criteria: - Treatment with IGlar or IDeg within the last 26 weeks prior to Visit
1 (short term use [less than or equal to 2 weeks] is allowed, but not within 4 weeks prior
to screening) - Use of any other anti-diabetic agent than those stated in the inclusion
criteria within the last 26 weeks prior to Visit 1