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    Summary
    EudraCT Number:2020-004774-22
    Sponsor's Protocol Code Number:GIP-SEMA
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-03-12
    Trial 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 ConcernedDenmark - DHMA
    A.2EudraCT number2020-004774-22
    A.3Full title of the trial
    The separate and combined effects of long-term GIP and GLP-1 receptor activation in patients with type 2 diabetes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effects of long-term treatment with the gut hormones GIP and GLP-1 in patients with type 2 diabetes
    A.3.2Name or abbreviated title of the trial where available
    GIP-SEMA
    A.4.1Sponsor's protocol code numberGIP-SEMA
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1259-1491
    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 SponsorHerlev Gentofte Hospital
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHerlev Gentofte Hospital
    B.4.2CountryDenmark
    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 organisationHerlev Gentofte Hospital
    B.5.2Functional name of contact pointClinical Metabolic Research
    B.5.3 Address:
    B.5.3.1Street AddressGentofte Hospitalsvej 7
    B.5.3.2Town/ cityHellerup
    B.5.3.3Post code2900
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4538674266
    B.5.6E-mailfilip.krag.knop.01@regionh.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Ozempic
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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) 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 No
    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 No
    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 nameGlucose-dependent insulinotropic polypeptide
    D.3.2Product code GIP(1-42)
    D.3.4Pharmaceutical form Infusion
    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 INNGlucose-dependent insulinotropic polypeptide
    D.3.9.1CAS number 59392-49-3
    D.3.9.3Other descriptive nameGastric inhibitory polypeptide
    D.3.9.4EV Substance CodeSUB223924
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/l millimole(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.8
    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) 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 No
    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 No
    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 placeboInjection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection/infusion
    D.8.4Route of administration of the placeboSubcutaneous 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
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes (T2D), formerly known as adult-onset 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 20.0
    E.1.2Level PT
    E.1.2Classification code 10012601
    E.1.2Term Diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 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
    The present study will evaluate the glucose-lowering effect (assessed by continuous glucose monitoring (CGM)) of the native hormone GIP in the context of pharmacological GLP-1 receptor activation in patients with type 2 diabetes. We hypothesise that long-term GLP-1 receptor agonism during concomitant GIP receptor agonism will disclose new physiological insights into glucose homeostasis and body weight regulation that may be used therapeutically in the future.
    E.2.2Secondary objectives of the trial
    The study will delineate the modulating metabolic effects beyond glycaemic effects (body composition, liver status, lipid profile, inflammatory markers, and vital signs) and, thus, provide important mechanistic insights into long-term dual GLP-1/GIP receptor agonism in these patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
    2. Men and women 18 to 74 years of age (both inclusive) at the time of signing informed consent
    3. Diagnosed with type 2 diabetes for at least six months.
    - Treated only with diet and exercise or stable metformin treatment for at least 3 months and be willing to continue the metformin dose during the trial
    - Glycated haemoglobin (HbA1C) 58-91 mmol/mol for patients treated with diet and exercise
    - HbA1C 53-91 mmol/mol for patients treated with metformin
    4. Body mass index (BMI) >27 to 50 kg/m2
    5. Stable body weight (less than 3 kg self-reported change during the previous 90 days)
    E.4Principal exclusion criteria
    1. Type 1 diabetes
    2. Known or suspected hypersensitivity to trial product or related products.
    3. Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (e.g. diabetes ketoacidosis) within 90 days prior to screening
    4. Previous participation in this trial. Participation is defined as signed informed consent.
    5. Participation in another clinical trial within 90 days before screening.
    6. Woman who are pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
    7. Any laboratory safety parameter at screening outside the laboratory ranges
    8. Any disorder which in the investigator’s opinion might jeopardise participant’s safety or compliance with the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Change in 14-day mean glucose levels (assessed by blinded continuous glucose monitoring (CGM)) during the last 14 days of the intervention period as compared to 14-day mean glucose levels during the last 14 days of the run-in period (from screening to first dose semaglutide).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to answer in E.5.1
    E.5.2Secondary end point(s)
    - Glycaemic variability will be assessed by 14-day coefficient of variance (CV) of glucose levels (assessed by CGM) during the last 14 days of the intervention period as compared to 14-day CV of glucose levels during the last 14 days of the run-in period (from screening to first dose semaglutide).
    - Time in range (TIR): Percentage time spent in hypoglycaemia, near-normoglycemia and hyperglycaemia during the during the last 14 days of the intervention period as compared to 14-day CV of glucose levels during the last 14 days of the run-in period (from screening to first dose semaglutide)
    - Glycaemic control assessed by HbA1C: Changes from baseline (visit 2) to end of the study (visit 7) in mean HbA1C.
    - Liver composition: Changes from baseline (visit 2) to end of the study (visit 7) in liver composition including liver fat and liver “stiffness” (or fibrosis) will be assessed by FibroScan (ultrasound-based elastography). Liver fat will be assessed by the controlled attenuation parameter (CAP) score in decibel per meter (dB/m) and liver stiffness measured by shear wave velocity in kilopascal (kPa).
    - Body composition: Changes from baseline (visit 2) to end of the study (visit 7) in body composition, total body fat percentage, total muscle mass percentage, and bone density (by T-score), will be assessed by dual-energy X-ray absorptiometry (DXA).
    - Body weight: Changes from baseline (visit 2) to end of the study (visit 7) in body weight
    - Lipid profile (including cholesterol, HDL, LDL, VLDL and triglycerides): Changes from baseline (visit 2) to end of the study (visit 7).
    - Blood pressure: Change from baseline (visit 2) to end of the study (visit 7) in mean systolic and diastolic blood pressure.
    - Heart rate: Change from baseline (visit 2) to end of the study (visit 7) in mean resting heart rate.
    - Brown adipose tissue (BAT) activity: Change from baseline (visit 2) to end of the study (visit 7) in mean BAT activity as measured by neck skin temperature
    - Waist circumference: Change from baseline (visit 2) to end of the study (visit 7) in mean waist circumference in centimetre (cm)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to answer in E.5.2
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) 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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Last subject last visit. October 2023.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    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: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state60
    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)
    Upon completion, participants will be offered referral to a diabetes clinic at a regional hospital.
    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 Decision2021-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-29
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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