Research study comparing a new medicine "fast-acting insulin aspart" to another already available medicine NovoRapid® in people with type 2 diabetes

• Register: EUCTR
• Last refreshed on: 30 April 2019
• Main ID: EUCTR2016-000878-38-GR
• Date of registration: 13/07/2017
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: Research study comparing a new medicine "fast-acting insulin aspart" to another already available medicine NovoRapid® in people with type 2 diabetes
• Scientific title: Efficacy and Safety of Fast-acting Insulin Aspart Compared to NovoRapid® both in Combination with Insulin Degludec with or without Metformin in Adults with Type 2 Diabetes - onset® 9
• Date of first enrolment: 02/08/2017
• Target sample size: 1262
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-000878-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: yes; Other trial design description: Treat-to-target; 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

Argentina, Bulgaria, Canada, Croatia, Czech Republic, European Union, Germany, Greece, Korea, Republic of, Russian Federation, Serbia, Spain, Ukraine, United States

Contacts

• Name: Clinical Disclosure (1452)
• Affiliation: Novo Nordisk A/S

• Name: Clinical Disclosure (1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

Inclusion criteria:
- Male or female, age = 18 years at the time of signing informed consent.
- Diagnosed with type 2 diabetes = 10 years prior to screening (Visit 1).
- Treated with a basal-bolus insulin regimen = 1 year prior to the day of screening (Visit 1). A
basal-bolus insulin regimen is defined as basal insulin once or twice daily and bolus insulin
analogue taken with meals at least 3 times daily. Treatment with premixed insulin or soluble
insulin combination is not considered a basal-bolus regimen.
- Treated with or without oral antidiabetic drugs including extended release formulations.
- HbA1c 7.0-10.0% (both inclusive) as assessed by central laboratory at screening (Visit 1).

Randomisation criterion:
- HbA1c = 9.0% measured by the central laboratory at Visit 13 (week -1).
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 965
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 107

Exclusion criteria:
- Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening (Visit 1).
- Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
- Planned coronary, carotid or peripheral artery revascularisation known on the day of screening (Visit 1).
- Treatment with injectable GLP-1 receptor agonists in a period of 90 days prior to screening (Visit 1).
- Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids).


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

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2
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]

Intervention(s)

Trade Name: Fiasp®
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin Aspart
CAS Number: 116094-23-6
Other descriptive name: INSULIN ASPART
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Trade Name: NovoRapid
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin Aspart
CAS Number: 116094-23-6
Other descriptive name: INSULIN ASPART
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Trade Name: Tresiba®
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin Degludec
CAS Number: 844439-96-9
Other descriptive name: INSULIN DEGLUDEC
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Secondary Objective: 1. To confirm superiority of fast-acting insulin aspart compared to NovoRapid® both in combination
with insulin degludec with or without metformin in adults with type 2 diabetes treated with a basal-bolus regimen in terms of:
- Postprandial glucose regulation
- Overall glycaemic control
- Postprandial glucose excursions

2. To compare the safety of fast-acting insulin aspart to NovoRapid® both in combination with insulin degludec with or without metformin in adults with type 2 diabetes treated with a basal-bolus regimen.

Main Objective: To confirm the effect in terms of glycaemic control of treatment with fast-acting insulin aspart compared to NovoRapid® both in combination with insulin degludec with or without metformin in adults with type 2 diabetes treated with a basal-bolus regimen, using a non-inferiority approach.

Primary end point(s): Change from baseline in HbA1c

Timepoint(s) of evaluation of this end point: 16 weeks after randomisation

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1.-2. 16 weeks after randomisation

Secondary end point(s): 1. Change from baseline in 1-hour postprandial glucose increment (meal test)
2. Change from baseline in 1,5-anhydroglucitol

Secondary ID(s)

2016-000878-38-BG

NN1218-4113

Source(s) of Monetary Support

Novo Nordisk A/S

Ethics review

Status: Approved
Approval date:
Contact: