Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-02-28 @ 5:57 PM
Study NCT ID:
NCT02206568
Status:
WITHDRAWN
Last Update Posted:
2020-07-15
First Post:
2014-07-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Ultra-Rapid-Acting Insulin Lispro (URAL) in Type 1 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-14', 'studyFirstSubmitDate': '2014-07-30', 'studyFirstSubmitQcDate': '2014-07-30', 'lastUpdatePostDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics of URAL', 'timeFrame': '1 day', 'description': 'Area under the serum insulin lispro concentration-time curve from 0-30 minutes after administration'}], 'secondaryOutcomes': [{'measure': 'Onset of appearance of serum insulin lispro', 'timeFrame': '1 day', 'description': 'Measurement of time to reach insulin lispro concentration \\>30 pmol/L in the serum'}, {'measure': 'Number of subjects with adverse events', 'timeFrame': '1 day', 'description': 'Assessment of safety and tolerability of URAL'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diabetes mellitus', 'phase 1', 'insulin lispro', 'male subjects'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'To compare the early pharmacokinetic exposure of URAL and insulin lispro (ILisp).', 'detailedDescription': 'To compare the total pharmacodynamic response of URAL and insulin lispro.\n\nTo compare the total pharmacokinetic exposure between URAL and insulin lispro.\n\nTo assess the safety and tolerability of URAL and insulin lispro.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Signed informed consent\n2. Male subjects age 18-65 years inclusive\n3. Type 1 diabetes mellitus diagnosed clinically \\>= 12 months\n4. Treatment with multiple daily insulin injections or CSII \\>= 12 months\n5. Current total daily insulin treatment \\<1.2 (I)U/kg/day\n6. Current total daily bolus insulin treatment \\<0.7 (I)U/kg/day\n7. Body mass index 18.0-30.0 kg/m2 inclusive\n8. HbA1c =\\<9.0% by local laboratory analysis (one retest within a week is permitted with the result of the last test being conclusive)\n9. C-peptide =\\< 0.30 nmol/L\n\nExclusion Criteria:\n\n1. Known or suspected hypersensitivity to trial products or related products\n2. Previous participation in this trial. .\n3. Receipt of any non-marketed investigational product within 3 months\n4. Clinically significant abnormal haematology, biochemistry, liver enzymes, or coagulation screening tests\n5. Suffer from or history of a life threatening disease or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal , neurological, psychiatric diseases or other major disorders\n6. History of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in 1st degree relatives\n7. Cardiac problems defined as decompensated heart failure (New York Heart Association class III and IV) at any time and/or angina pectoris within the last 12 months and/or acute myocardial infarction at any time.\n8. Supine blood pressure at screening outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic . Pulse outside 50 to 90 bpm.\n9. Clinically significant abnormal ECG at screening.\n10. Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy.\n11. Any disease or condition that, in the opinion of the Investigator, would represent an unacceptable risk for the subject's safety.\n12. Subject positive for HBs-Ag, HCV-Ab\n13. Positive result to the screening test for HIV-1 antibodies, HIV-2 antibodies, or HIV-1 antigen according to locally used diagnostic testing.\n14. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.\n15. Subject who has donated blood or plasma in the past month or more than 500 mL within 3 months.\n16. Surgery or trauma with significant blood loss (more than 500 mL) within 3 months.\n17. Current treatment with systemic (oral, IV, or inhaled) corticosteroids, monoamine oxidase inhibitors, NSAID, prostaglandin blockers, systemic non-selective beta-blockers, growth hormone (last 3 months), non-routine vitamins or herbal products (last 2 weeks). Thyroid hormones are not allowed unless the use of these has been stable during the last 3 months. Routine vitamins are permitted up to 48 hours prior to dosing.\n18. Significant history of alcoholism and/or drug/chemical abuse as per Investigator's judgement or a positive result in the urine drug/alcohol breath test screen at the screening visit.\n19. Heavy smoker\n20. Not able or willing to refrain from smoking and use of nicotine.\n21. Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemia event during the last 12 months) or hypoglycaemic unawareness.\n22. Subject with mental incapacity or language barriers precluding adequate understanding.\n23. Potentially non-compliant or uncooperative during the trial.\n24. Any condition that would interfere with trial participation or evaluation of results.\n25. No relevant lipodystrophy within the area of drug administration and Doppler sonography."}, 'identificationModule': {'nctId': 'NCT02206568', 'briefTitle': 'Pharmacokinetics of Ultra-Rapid-Acting Insulin Lispro (URAL) in Type 1 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'AMAG Pharmaceuticals, Inc.'}, 'officialTitle': 'A Randomised Trial Investigating Pharmacokinetic Properties of Ultra-Rapid-Acting Insulin Lispro (URAL) in Subjects With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'PER511'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'URAL vs. Insulin lispro', 'description': 'Each subject will randomly be allocated to a treatment sequence consisting of 2 dosing visits during which the subject in a euglycaemic clamp setting will receive either a single dose of insulin lispro or URAL at predefined fixed dose levels in a randomized order.', 'interventionNames': ['Drug: URAL']}], 'interventions': [{'name': 'URAL', 'type': 'DRUG', 'otherNames': ['Ultra-Rapid-Acting Insulin Lispro'], 'armGroupLabels': ['URAL vs. Insulin lispro']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Neuss', 'country': 'Germany', 'facility': 'Profil Institut fur Stoffwechselforschung GmbH', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'overallOfficials': [{'name': 'Alin Stirban, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Profil Institut fur Stoffwechselforschung GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Profil Institut für Stoffwechselforschung GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}