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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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8 October 2021 |
Main ID: |
EUCTR2008-005767-34-FR |
Date of registration:
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06/08/2009 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A trial comparing efficacy and safety of NN5401 with
insulin glargine, both in combination with oral
antidiabetic drugs in subjects with type 2 diabetes
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Scientific title:
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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:
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04/11/2009 |
Target sample size:
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450 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005767-34 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no 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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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France
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Poland
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Sweden
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Key inclusion & exclusion criteria
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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:
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Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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type 2 diabetes mellitus MedDRA version: 12.0
Level: LLT
Classification code 10045242
Term: Type II diabetes mellitus
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Intervention(s)
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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(R) 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-
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Primary Outcome(s)
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Primary end point(s): Change from baseline in HbA1c after 26 weeks of treatment (analysed by central laboratory)
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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%.
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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
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Secondary ID(s)
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NN5401-3593
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2008-005767-34-SE
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 04/11/2009
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