Overview

A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, With or Without OADs in Subjects With Type 2 Diabetes

Status:
Completed
Trial end date:
2015-12-04
Target enrollment:
0
Participant gender:
All
Summary
This trial is conducted in 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) with or without OADs (oral anti-diabetic drugs) excluding SUs (sulfonylureas)/glinides in subjects with type 2 diabetes.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Treatments:
Insulin
Insulin Glargine
Insulin, Globin Zinc
Insulin, Long-Acting
Criteria
Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed
consent - Subjects fulfilling at least one of the below criteria: a) Experienced at least
one severe hypoglycaemic episode within 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) by central laboratory analysis, c) Hypoglycaemic symptom
unawareness, d) Exposed to insulin for more than 5 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) - Type 2 diabetes mellitus (diagnosed clinically) for at
least 26 weeks prior to Visit 1 - Current treatment with any basal insulin (OD or BID) ±
any combination of OADs (metformin, DPP-4 inhibitor, alpha-glucosidase inhibitor,
thiazolidinediones, and SGLT2-inhibitor) for 26 weeks or longer prior to Visit 1 For
subjects on BID the total daily dose should be below 75 units - HbA1c (glycosylated
haemoglobin) below or equal to 9.5 % by central laboratory analysis - BMI (body mass index)
below or equal to 45 kg/m^2 Exclusion Criteria: - Treatment with a bolus insulin separately
or contained in an insulin mix product within the last 26 weeks prior to Visit 1 - Use of
any other anti-diabetic agent(s) than those stated in the inclusion criteria within the
last 26 weeks prior to Visit 1