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

• Conditions: Diabetes Mellitus, Type 1; MedDRA version: 17.0Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-001930-32-PL
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-04
• Last Update Posted: 25 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 446

Inclusion Criteria

1. Male or female, age = 18 years at the time of signing informed consent
2. 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 definition, April 2013)
b) Moderate chronic renal failure, defined as glomerular filtration rate 30 - 59 mL/min/1.73 m^2 per CKD-Epi
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 (= 70 mg/dL [= 3.9 mmol/L])) within the last 12 weeks prior to Visit 1 (screening)
3. Type 1 diabetes mellitus (diagnosed clinically) = 52 weeks prior to Visit 1
4. Current treatment with a basal-bolus regimen (consisting of neutral protamine Hagedorn (NPH) insulin OD / BID or insulin detemir (IDet) OD / BID plus 2-4 daily injections of any rapid acting or fast acting meal time insulin) or CSII (with rapid acting insulin) for = 26 weeks prior to Visit 1
5. HbA1c = 10% by central laboratory analysis
6. BMI = 45 kg/m^2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 424
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

Exclusion Criteria

1. Treatment with IGlar or IDeg within the last 26 weeks prior to Visit 1 (short term use [= 2 weeks] is allowed, but not within 4 weeks prior to screening)
2. Use of any other anti-diabetic agent than those stated in the inclusion criteria within the last 26 weeks prior to Visit 1

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified