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    Summary
    EudraCT Number:2011-004930-33
    Sponsor's Protocol Code Number:BIASP-3963
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-01
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPortugal - INFARMED
    A.2EudraCT number2011-004930-33
    A.3Full title of the trial
    A 24 week randomised, open label, 3 parallel-group
    comparison of once and twice daily biphasic insulin
    aspart (BIAsp) 30 plus sitagliptin and twice daily BIAsp
    30, all in combination with metformin in insulin naïve
    type 2 diabetic subjects inadequately controlled on
    sitagliptin and metformin
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment intensification with biphasic insulin aspart 30 in subjects with type 2 diabetes inadequately controlled on sitagliptin and metformin
    A.3.2Name or abbreviated title of the trial where available
    SIT2MIX
    A.4.1Sponsor's protocol code numberBIASP-3963
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1125-0850
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovo Nordisk A/S
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovo Nordisk A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovo Nordisk A/S
    B.5.2Functional name of contact pointGlobal Clinical Registry (GCR,1452)
    B.5.3 Address:
    B.5.3.1Street AddressVandtaarnsvej 114,VTB
    B.5.3.2Town/ citySoeborg
    B.5.3.3Post codeDK-2860
    B.5.3.4CountryDenmark
    B.5.6E-mailclinicaltrials@novonordisk.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name NovoMix 30 FlexPen 100 U/mL suspension for injection in a prefilled pen.
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Suspension for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINSULIN ASPART
    D.3.9.1CAS number 116094-23-6
    D.3.9.4EV Substance CodeSUB08195MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetes Mellitus, Type 2
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy in terms of glycaemic control of biphasic insulin aspart 30 (BIAsp 30) twice daily + sitagliptin + metformin, BIAsp 30 twice daily + metformin and BIAsp 30 once daily + sitagliptin + metformin in subjects with type 2 diabetes inadequately controlled on sitagliptin and metformin (± other oral anti-diabetic drugs (OADs))
    E.2.2Secondary objectives of the trial
    To compare the safety, patient reported treatment impact and the health economic consequences of BIAsp 30 twice daily + sitagliptin + metformin, BIAsp 30 twice daily + metformin and BIAsp 30 once daily + sitagliptin + metformin in subjects with type 2 diabetes inadequately controlled on sitagliptin and metformin (± other OADs)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female, age ≥ 18 years
    - Diagnosed with type 2 diabetes for a minimum of 6 months prior to screening (Visit 1)
    - Stable treatment with a total daily dose of at least 1000 mg of metformin (± additional OAD treatment). The metformin dose must have been unchanged for at least 3 months prior to screening (Visit 1)
    - Stable treatment with a total daily dose of at least 100 mg sitagliptin. The sitagliptin dose must have been unchanged for at least 3 months prior to screening (Visit 1)
    - Subject is insulin-naïve (However, short term insulin use due to intermittent illness of up to 14 days or insulin treatment for gestational diabetes is allowed)
    - HbA1c 7.0-10.0 % (53-86 mmol/mol) (both inclusive) by central laboratory analysis demonstrating inadequate control on sitagliptin and metformin (± other OADs)
    - Body Mass Index (BMI) ≤ 40.0 kg/m^2
    - Able and willing to eat at least 2 meals (breakfast and dinner) every day during the trial
    E.4Principal exclusion criteria
    - Treatment with thiazolidinedione (TZD) or glucagon-like-peptide-1 (GLP-1) receptor agonist within the last 3 months prior to screening (Visit 1)
    - Cardiac disease, within the last 6 months prior to screening (Visit 1), defined as: decompensated heart failure New York Heart Association (NYHA) class III or IV; unstable angina pectoris; or myocardial infarction
    - Severe hypertension, systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≥ 100 mm Hg, after 5 minutes rest in the sitting position using mean value of 3 measurements at screening (Visit 1)
    - Anticipated change of dose of any systemic treatment with products, which in the investigator’s opinion could interfere with glucose metabolism (e.g., systemic corticosteroids)
    - Clinically significant diseases (except for conditions associated with type 2 diabetes) which, in the investigator’s opinion may confound the results of the trial or pose additional risk in administering trial product(s)
    - Impaired hepatic function as indicated by aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) > 2.5 times the upper normal range, according to central laboratory reference ranges
    - Impaired renal function as indicated by serum creatinine levels ≥ 133 μmol/L (1.5 mg/dL) for males and ≥ 124 μmol/L (1.4 mg/dL) for females or estimated creatinine clearance below 60 mL/min, based on the Cockroft & Gault formula and according to local practise for metformin use
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in HbA1c after 24 weeks of treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 24 weeks of treatment
    E.5.2Secondary end point(s)
    Key secondary endpoint supporting primary objective

    1. Responder for HbA1c, proportion of subjects achieving pre-defined HbA1c targets after 24 weeks of treatment
    2. Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment
    3. Prandial plasma glucose (PPG) increments at each meal (breakfast, lunch and dinner) and overall mean increment after 24 weeks of treatment

    Key secondary safety endpoints supporting the secondary objective

    4. Adverse Events (AEs) during the 24 week treatment period
    5. Number of treatment emergent hypoglycaemic episodes (nocturnal and day-time) during the 24 week treatment period classified both according to the American Diabetes Association (ADA) definition and to an additional definition for minor episodes

    Key secondary efficacy endpoints supporting the secondary objectives

    6. Change from baseline in Patient Reported Outcome after 24 weeks of treatment by use of the Treatment Related Impact Measure - Diabetes
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. After 24 weeks of treatment
    2. After 24 weeks of treatment
    3. After 24 weeks of treatment
    4. During the 24 week treatment period
    5. During the 24 week treatment period
    6. After 24 weeks of treatment
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    3 different combinations and dosing regimen
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Greece
    India
    Korea, Republic of
    Malaysia
    Portugal
    Thailand
    Turkey
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days14
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 488
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 85
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 573
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    N/A
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-03-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-10-18
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