A trial comparing the efficacy and safety of insulin degludec and insulin glargine 300 units/mL in subjects with type 2 diabetes mellitus inadequately treated with basal insulin with or without oral antidiabetic drugs

Phase 1

• Conditions: MedDRA version: 20.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]; Diabetes Mellitus, Type 2

• Registration Number: EUCTR2016-002801-20-DE
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-05
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1590

Inclusion Criteria

- Male or female, age above or equal to 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 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 by central laboratory analysis.
c. Hypoglycaemic symptom unawareness***.
d. Treated with insulin for more than 5 years.
e. 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).
- Subjects diagnosed (clinically) with type 2 diabetes mellitus.
- Treated with basal only insulin (once daily or twice-daily insulin (insulin detemir; insulin
glargine 100 U/mL, biosimilar of insulin glargine 100 U/mL or insulin Neutral Protamine
Hagedorn)) at least 90 days prior to the day of screening with or without any of the following
anti-diabetic drugs with stable doses for at least 90 days prior to screening:
a Metformin
b Dipeptidyl peptidase -4 inhibitor
c Sodium-glucose co-transporter 2 inhibitor
d Alpha-glucosidase-inhibitors (acarbose)
e Thiazolidinediones
f Marketed oral combination products only including the products listed in criteria 5a-
5e
- HbA1c below or equal to 9.5% (80 mmol/mol) at screening by central laboratory analysis.
- BMI below or equal to 45 kg/m^2.
* For this inclusion criterion the aim is to include minimum 80% of individuals with a previous
episode of hypoglycaemia (criterion e). The remaining subjects will have to fulfil at least one of
criteria a-d.
** An episode requiring assistance of another person to actively administer carbohydrate, glucagon,
or take other corrective actions. Plasma glucose concentrations may not be available during an
event, but neurological recovery following the return of plasma glucose to normal is considered
sufficient evidence that the event was induced by a low plasma glucose concentration.
*** History of impaired autonomic responses (tremulousness, sweating, palpitations, and hunger)
during hypoglycaemia.
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 994
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 596

Exclusion Criteria

- Treatment with any medication for the indication of diabetes or obesity other than stated in
the inclusion criteria in a period of 90 days before the day of screening.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: To compare the effects of insulin degludec once daily and insulin glargine 300 units/mL once daily<br> on hypoglycaemia in subjects with type 2 diabetes mellitus, inadequately treated with basal insulin<br> with or without oral anti-diabetic drugs.<br> ;<br> Secondary Objective: To compare insulin degludec and insulin glargine 300 units/mL in terms of basal insulin<br> requirement.<br> To compare insulin degludec and insulin glargine 300 units/mL in terms of safety and parameters of<br> glycaemic control.<br> ;Primary end point(s): 1. Number of severe or blood glucose confirmed symptomatic hypoglycaemic episodes ;Timepoint(s) of evaluation of this end point: 1. During maintenance 2 (36 weeks)