A trial comparing efficacy and safety of NN5401 with insulin glargine, both in combination with oral antidiabetic drugs in subjects with type 2 diabetes

• Register: EUCTR
• Last refreshed on: 12 June 2012
• Main ID: EUCTR2008-005767-34-SE
• Date of registration: 03/08/2009
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: A trial comparing efficacy and safety of NN5401 with insulin glargine, both in combination with oral antidiabetic drugs in subjects with type 2 diabetes
• Scientific title: A trial comparing efficacy and safety of NN5401 with insulin glargine, both in combination with oral antidiabetic drugs in subjects with type 2 diabetes
• Date of first enrolment: 07/10/2009
• Target sample size: 450
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005767-34
• 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

Countries of recruitment

France, Poland, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
• Informed consent obtained before any trial-related activities. (Trial related activities are defined as any procedures that would not have been performed during standard management of the subject).
• Male or female = 18 years of age
• Type 2 diabetes mellitus (diagnosed clinically) for = 6 months
• Treatment with basal insulin regimen (insulin detemir, insulin glargine or neutral protamine Hagedorn [NPH] insulin) OD, for at least 3 months
• Ongoing treatment with: metformin with or without other OADs for at least 3 months prior to randomisation
• HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
• BMI = 40.0 kg/m²

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• Treatment with insulin regimens other than a basal insulin regimen (insulin detemir or insulin glargine or NPH insulin) OD within 3 months prior to Visit 1
• Total daily insulin dose above 1 U/kg
• Treatment with glucagon-like peptide 1(GLP-1) receptor agonists within 3 months prior to visit 1
• Current rosiglitazone users
• Anticipated significant lifestyle changes during the study, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits
• Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke;
decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty


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

Health Condition(s) or Problem(s) studied

type 2 diabetes mellitus
MedDRA version: 12.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus

Intervention(s)

Product Name: SIAC
Product Code: NN5401
Pharmaceutical Form: Solution for injection
CAS Number: 844439-96-9
Current Sponsor code: NNC 0100-0000-0454
Other descriptive name: insulin 454
Concentration unit: nmol/ml nanomole(s)/millilitre
Concentration type: equal
Concentration number: 420-
CAS Number: 116094-23-6
Other descriptive name: insulin aspart
Concentration unit: nmol/ml nanomole(s)/millilitre
Concentration type: equal
Concentration number: 180-

Trade Name: Lantus®
Pharmaceutical Form: Solution for injection
CAS Number: 160337-95-1
Other descriptive name: insulin glargine
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Secondary Objective: To confirm superiority of SIAC OD + metformin ± pioglitazone ± DPP-4 inhibitors over insulin
glargine + metformin ± pioglitazone ± DPP-4 inhibitors after 26 weeks of treatment in terms of
• Prandial plasma glucose (PG) increment
• Frequency of responders for HbA1c (<7%) without hypoglycaemic episodes
• Fluctuation in nocturnal interstitial glucose (IG)
• Nocturnal hypoglycaemic episodes
• Body weight
To compare efficacy and safety after 26 weeks of treatment in terms of:
• Fasting plasma glucose (FPG) from central laboratory
• 9-point self measured plasma glucose (SMPG) profile
• SMPG for dose adjustments
• Frequency of responders for HbA1c
• Glucose profile as measured with CGM in a sub-population
• Insulin dose
• Adverse events
• Hypoglycaemic episodes
• Clinical and laboratory assessments
• Patient reported outcome

Main Objective: To confirm the efficacy of SIAC OD + metformin ± pioglitazone ± DPP-4 inhibitors in controlling glycaemia with respect to change from baseline in HbA1c after 26 weeks of treatment. This is done by comparing the difference in change from baseline in HbA1c between SIAC OD + metformin ± pioglitazone ± DPP-4 inhibitors and insulin glargine OD + metformin ± pioglitazone ± DPP-4 inhibitors to a non-inferiority limit of 0.4%, and if non-inferiority is confirmed, to a superiority limit of 0%.

Primary end point(s): Change from baseline in HbA1c after 26 weeks of treatment (analysed by central laboratory)

Secondary ID(s)

NN5401-3593