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

• Register: EUCTR
• Last refreshed on: 30 April 2019
• Main ID: EUCTR2016-002801-20-HU
• Date of registration: 06/12/2016
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 19/01/2017
• Target sample size: 1590
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-002801-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Canada, Denmark, Estonia, European Union, Germany, Greece, Hungary, Norway, Poland, Serbia, United States

Contacts

• Name: Global Clinical Registry (GCR,1452)
• Affiliation: Novo Nordisk A/S

• Name: Global Clinical Registry (GCR,1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2
MedDRA version: 19.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Intervention(s)

Trade Name: Toujeo® 300 units/ml
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: INSULIN GLARGINE
CAS Number: 160337-95-1
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 300-

Trade Name: Tresiba® 200 units/ml
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: INSULIN DEGLUDEC
CAS Number: 844439-96-9
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 200-

Primary Outcome(s)

Primary end point(s): 1. Number of severe or blood glucose confirmed symptomatic hypoglycaemic episodes

Secondary Objective: To compare insulin degludec and insulin glargine 300 units/mL in terms of basal insulin
requirement.
To compare insulin degludec and insulin glargine 300 units/mL in terms of safety and parameters of
glycaemic control.

Main Objective: To compare the effects of insulin degludec once daily and insulin glargine 300 units/mL once daily
on hypoglycaemia in subjects with type 2 diabetes mellitus, inadequately treated with basal insulin
with or without oral anti-diabetic drugs.

Timepoint(s) of evaluation of this end point: 1. During maintenance period (week 16-52)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1. At 52 weeks
2. During maintenance period (week 16-52)
3. During 52 weeks
4. During maintenance period (week 16-52)
5. From baseline to 52 weeks
6. During 52 weeks
7. During 52 weeks
8. During 52 weeks

Secondary end point(s): 1. Basal insulin dose (units)
2. Number of nocturnal, severe or blood glucose confirmed symptomatic hypoglycaemic
episodes
3. Number of severe or blood glucose confirmed symptomatic hypoglycaemic episodes
4. Number of severe hypoglycaemic episodes
5. Change in HbA1c
6. Hypoglycaemia: Number of nocturnal, severe or blood glucose confirmed symptomatic
hypoglycaemic episodes
7. Hypoglycaemia: Number of severe hypoglycaemic episodes
8. Number of adverse events

Secondary ID(s)

2016-002801-20-DE

NN1250-4252

Source(s) of Monetary Support

Novo Nordisk A/S

Ethics review

Status: Approved
Approval date:
Contact: