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    Summary
    EudraCT Number:2010-024303-27
    Sponsor's Protocol Code Number:BIASP-3878
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-05-26
    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 ConcernedUK - MHRA
    A.2EudraCT number2010-024303-27
    A.3Full title of the trial
    A 20 weeks randomised, multinational, open labelled, 2 armed, parallel group comparison of twice daily subject-driven titration of biphasic insulin aspart (BIAsp) 30 versus twice daily investigator-driven titration of biphasic insulin aspart (BIAsp) 30 both in combination with metformin in subjects with type 2 diabetes inadequately controlled on basal insulin analogues
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 20 weeks randomised, multinational, open labelled,2 parallel group comparison of biphasic insulin aspart (BIAsp) 30 in combination with metformin in subjects with type 2 diabetes, which is inadequately controlled on basal insulin analogues. One treatment group use twice daily titration of biphasic insulin aspart 30 driven by the subject, the other group use twice daily titration of biphasic insulin aspart 30 driven by the investigator. Both groups combine their treatment with metformin.
    A.3.2Name or abbreviated title of the trial where available
    SimpleMix™
    A.4.1Sponsor's protocol code numberBIASP-3878
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1118-4096
    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 pre-filled 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.3.10 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
    Type 2 diabetes
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10063624
    E.1.2Term Type II diabetes mellitus inadequate control
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    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 confirm efficacy of subject-driven titration of biphasic insulin aspart (BIAsp) 30 twice daily in
    terms of glycaemic control assessed by change in glucosylated haemoglobin (HbA1c). This is done
    by showing that subject-driven titration of BIAsp 30 is non-inferior to investigator-driven titration
    of BIAsp 30 with respect to glycaemic control, as measured by HbA1c after 20 weeks of treatment
    in subjects with type 2 diabetes inadequately controlled on basal insulin analogues.
    E.2.2Secondary objectives of the trial
    - To assess and compare efficacy in terms of:
    - Fasting plasma glucose (FPG) values
    - 7-point Self Measured Plasma Glucose (SMPG) profile
    - To assess and compare safety and tolerability in terms of:
    - Hypoglycaemic episodes
    - Adverse events (AEs)
    - Clinical and laboratory assessments
    - Change in body weight
    - To assess time to plasma glucose (PG) target in terms of:
    2-point Self Measured Plasma Glucose (SMPG) profile
    - To evaluate insulin dose
    - To assess diabetes treatment satisfaction
    - To assess healthcare resource utilization
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female, age ≥18
    - Diagnosed with type 2 diabetes for a minimum of 12 months prior to Visit 1
    - Currently treated with a basal insulin analogue for at least 3 months prior to Visit 1
    - Stable treatment (no change in dose or regimen) with a total daily dose of at least 1500 mg
    metformin or maximum tolerated dose (minimum 1000 mg) ± additional OAD treatment. The
    metformin treatment must have been stable for at least 2 months prior to Visit 1
    - HbA1c ≥ 7.0% and ≤10.0%. (One re-test within one week of screening visit is allowed. The last
    sample will be conclusive.)
    - Body Mass Index (BMI) ≤ 40.0 kg/m2
    - Able and willing to eat at least 2 main meals each day during the trial
    - Able and willing to adhere to the protocol including compliance with performance of self
    measured plasma glucose (SMPG), injection regimen and titrating themselves according to the
    protocol
    - Experience in performing self measured plasma glucose (SMPG)
    E.4Principal exclusion criteria
    - Treatment with any thiazolidinedione (TZD) and Glucagon-like peptide-1 (GLP-1) receptor
    agonists or pramlintide within the last 3 months prior to Visit 1
    - Impaired hepatic function defined as alanine aminotransferase (ALAT)≥ 2.5 times upper
    referenced limit. (One re-test within one week of screening visit is allowed. The last sample will
    be conclusive.)
    - Impaired kidney function with serum creatinine ≥ 133 μmol/L (1.5 mg/dL) for males and ≥ 124
    μmol/L (1.4 mg/dL) for females. (One re-test within one week of screening visit is allowed. The
    last sample will be conclusive.)
    - Cardiac problems or uncontrolled treated/untreated severe hypertension (defined as systolic
    blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100 mmHg)
    - Previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed human
    preparations) or bolus insulin. Previous use of pre-mixed or bolus insulin products is allowed only in case of hospitalisation or a severe condition requiring intermittent use of premixed or bolus insulin products for less than 14 consecutive days, but not during the last 3 months prior to screening visit (Visit 1)
    E.5 End points
    E.5.1Primary end point(s)
    Change in HbA1c from baseline to week 20/end of trial
    E.5.1.1Timepoint(s) of evaluation of this end point
    from baseline to week 20/end of trial
    E.5.2Secondary end point(s)
    1- Change in fasting plasma glucose (FPG) (central laboratory values) from baseline to week
    20/end of trial
    2- Number of hypoglycaemic episodes during the trial
    3- Patient Reported Outcomes evaluated at baseline, at week 4 and at week 20/end of trial with:
    - Treatment-Related Impact Measures for Diabetes (TRIM-D)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1- from baseline to week
    20/end of trial
    - during the trial
    - at baseline, at week 4 and at week 20/end of trial with:
    - Treatment-Related Impact Measures for Diabetes (TRIM-D)
    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) No
    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
    Two methods of titration
    E.8.2.4Number of treatment arms in the trial2
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    China
    India
    Poland
    Spain
    Turkey
    United Kingdom
    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 years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days24
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days24
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 270
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 68
    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 state31
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 91
    F.4.2.2In the whole clinical trial 338
    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 Decision2011-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-07-13
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