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    Summary
    EudraCT Number:2008-006215-20
    Sponsor's Protocol Code Number:0941-018
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-12-09
    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 ConcernedSweden - MPA
    A.2EudraCT number2008-006215-20
    A.3Full title of the trial
    A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
    of MK-0941 in Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Insulin
    A.4.1Sponsor's protocol code number0941-018
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Sharp & Dohme (Sweden) AB
    B.1.3.4CountrySweden
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    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.3.1Product nameMK-0941
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.IMP: 2
    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 No
    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.3.1Product nameMK-0941
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 2 diabetes mellitus
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    After 20 weeks, to assess the effect of treatment with MK-0941
    compared with placebo on A1C when added to basal insulin.
    E.2.2Secondary objectives of the trial
    (1) To assess the safety and tolerability of MK-0941. (2) After 20 weeks, to assess the effect of treatment with MK-0941 compared with placebo on fasting plasma glucose when added to basal insulin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient is between 21 and 70 years of age.
    2. Patient has type 2 diabetes mellitus and meets one of the following criteria:
    • On a stable dose of Lantus insulin monotherapy >=15 units/day for at least 6 weeks and has a Visit 1/Screening Visit A1C of ≥7.5% and 11.0%
    • On any injectable insulin (other than Lantus) at a stable dose of >=15 units/day, either alone or in combination with an oral monotherapy agent for at least 6 weeks and has a Visit 1/Screening A1C of ≥7.0% and 10.5%
    • On any injectable insulin at a stable dose of >=15 units/day, in combination with two oral agents for at least 6 weeks and has a Visit 1/Screening A1C of ≥6.5% and <=10.0%
    3. Patient is a male or a female who is highly unlikely to conceive (i.e., patient is a male, patient is not of reproductive potential, patient is of reproductive potential and agrees to remain abstinent or use 2 acceptable methods of birth control).
    E.4Principal exclusion criteria
    1. Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis.
    2. Patient has received more than 1 week of dosing of TZD therapy within the past 8 weeks.
    3. Patient has a history of severe hypoglycemia defined as 2 or more episodes during his/her lifetime or one episode within the past year that resulted in hypoglycemic seizures and/or cerebral impairment (e.g. coma, severe confusion, etc.) or patient has had hypoglycemia unawareness (i.e.,fingerstick glucose <50 mg/dL [2.8 mmol/L] without symptoms) within the past 3 months.
    4. Patient has a contraindication to Lantus insulin.
    5. Patient is allergic to ophthalmologic dilation medications (i.e., cyclophenylate, phenylephrine)
    6. Patient meets one of the following medication exclusions:
    • Taking weight loss medication (e.g. orlistat, sibutramine, rimonabant, etc) within 8 weeks of Visit 1/Screening Visit.
    • Currently taking or likely to require treatment with > 14 consecutive days or repeated courses of pharmacological doses of systemic (oral, injectable/parenteral) or ocular corticosteroids during the study. (NOTE: oral corticosteroids used for physiologic replacement therapy (e.g. in patients with adrenal insufficiency) and inhaled, nasal, and topical (i.e. dermatological) corticosteroids are allowed).
    • Currently on or likely to require treatment with warfarin or warfarin-like anticoagulants, digoxin, or any other medication with a narrow therapeutic index.
    • Under treatment with anti-thyroid medication or radioactive iodine for hyperthyroidism.
    • Currently treated or likely to require treatment with the following glaucoma medications: ecothiophate, pilocarpine, or carbachol
    7. Patient meets one of the following medical exclusions:
    • New or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months
    • Any of the following in the past 6 months: acute coronary syndrome, cerebral vascular accident, or TIA
    • NYHA Class II-IV cardiac status or severe peripheral vascular disease
    • Chronic myopathy or a progressive neurological or neuromuscular disorder
    • A systolic blood pressure of ≥160mm Hg or diastolic blood pressure of ≥90mm Hg.
    • Active nephropathy
    • Active liver disease (other than non-alcoholic hepatic steatosis), active viral hepatitis, cirrhosis, or symptomatic gallbladder disease
    • HIV positive
    • Clinically significant hematological disorder
    • History of malignancy < 5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer (NOTE: Melanoma, leukemia, myeloproliferative disorders and renal cell carcinoma of any duration are excluded)
    • Ocular herpes, uveitis, or iritis within 3 months prior to screening or has a history of recurrent episodes of any of these three conditions.
    • Poorly controlled hypertension
    • Any other condition which, in the opinion of the investigator, might pose a risk to the patient or make participation not in the patient's best interest, that might confound the results of the study, or interfere with the patient's participation for the full duration of the study
    8. Patient has undergone surgery within 30 days prior to Visit 1/Screening Visit or has planned major surgery.
    9. Patient has had coronary artery intervention (e.g. coronary artery bypass graft or percutaneous transluminal coronary angioplasty within the past 6 months
    10. Patient has had, or is anticipated to have intraocular surgery within 6 months prior to Visit 1 or during the study or has had laser eye surgery within 3 months prior to screening (LASIK is permitted).
    11. Patient has any existing condition which will preclude Lens Opacities Classification System (LOCS) III examination and retinal examination in both eyes. Note: Patients with history of unilateral or bilateral cataract extraction which occurred more than 6 months prior to screening may participate.
    12. At randomization (Visit 5/Day 1) patient has a site fasting fingerstick glucose <130 mg/dL (7.2 mmol/L) or >240 mg/dL (13.3 mmol/L).
    13. Patient is pregnant or breast-feeding, or expecting to conceive during the duration of the study.
    14. Patient is currently participating, or has participated in a study with an investigational compound or device within 3 months of signing informed consent and is not willing to refrain from participating in another study for 3 months after completing this study.
    15. Patient is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history of drug abuse or increased alcohol consumption.
    16. Patient has poor mental function or any other reason to expect that the patient may have difficulty in complying with the requirements of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in A1C at Week 20.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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 Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    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
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 87
    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 Decision2009-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-02-17
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