Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2026-01-24 @ 12:27 AM
Study NCT ID:
NCT02915250
Status:
COMPLETED
Last Update Posted:
2017-06-29
First Post:
2016-09-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to Compare Post Prandial Blood Glucose Control of BioChaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061268', 'term': 'Insulin Lispro'}, {'id': 'D000069036', 'term': 'Insulin Glargine'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D049528', 'term': 'Insulin, Long-Acting'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-28', 'studyFirstSubmitDate': '2016-09-21', 'studyFirstSubmitQcDate': '2016-09-23', 'lastUpdatePostDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delta AUC BG 0-2h (area under the blood glucose concentration-time curve)', 'timeFrame': 'From 0 to 2 hours', 'description': 'Mean of incremental areas under the blood glucose concentration-time curve from 0-2 hours after a standardised meal on Day 2 and Day 3'}], 'secondaryOutcomes': [{'measure': 'Partial delta AUCs BG and total AUCs BG', 'timeFrame': 'From 0 to 6 hours', 'description': 'Partial incremental AUCs BG and total AUCs BG in the 0-6 time range'}, {'measure': 'Mean and mean change from baseline of blood glucose at different time points', 'timeFrame': 'From 0 to 6 hours'}, {'measure': 'Delta BGmax and delta BGmin', 'timeFrame': 'From 0 to 6 hours', 'description': 'Maximum and minimum blood glucose excursions after a standardised meal'}, {'measure': 'BGmax and BGmin', 'timeFrame': 'From 0 to 6 hours', 'description': 'Maximum and minimum blood glucose concentrations after a standardised meal'}, {'measure': 'AUC Insulin', 'timeFrame': 'From 0 to 24 hours', 'description': 'Partial areas under the insulins plasma concentration time curve'}, {'measure': 'Cmax Insulin', 'timeFrame': 'From 0 to 6 hours', 'description': 'Maximum observed plasma insulins concentration'}, {'measure': 'tmax Insulin', 'timeFrame': 'From 0 to 6 hours', 'description': 'Time to maximum observed plasma insulins concentration'}, {'measure': 'Adverse Events', 'timeFrame': "Up to 12 weeks (maximum duration of subject's participation)"}, {'measure': 'Local tolerability', 'timeFrame': "Up to 12 weeks (maximum duration of subject's participation)"}, {'measure': 'Hypoglycaemic events', 'timeFrame': "Up to 12 weeks (maximum duration of subject's participation)"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This is a two-centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over study using a standardised solid meal test in subjects with type 2 diabetes to investigate postprandial glucose control of BioChaperone® Combo compared with Humalog® Mix25 and with simultaneous subcutaneous injections of Humalog® and Lantus® during three separate dosing visits.', 'detailedDescription': 'This is a two-centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over study using a standardised solid meal test in subjects with type 2 diabetes to investigate postprandial glucose control of BioChaperone® Combo compared with Humalog® Mix25 and with simultaneous subcutaneous injections of Humalog® and Lantus® during three separate dosing visits.\n\nFurthermore, this study aims to compare the pharmacokinetic (PK) profiles of the three different study treatments.\n\nDuring each dosing visit, subjects will be given 3 doses of IMP on three consecutive days (Day 1, Day 2 and Day 3). Dosing on Day 2 and Day 3 will be followed by a standardised solid meal test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subject aged 18-70 years (both inclusive)\n* Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months\n* HbA1c level between 7.5% and 9.5% (both inclusive)\n* Body mass index between 20.0 and 40.0 kg/m2 (both inclusive)\n* Treated with once daily injections with insulin glargine U-100 for ≥ 3 months prior to screening\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus\n* Known or suspected allergy to the IMPs or related products\n* Previous participation in this trial. Participation is defined as randomised.\n* Receipt of any medicinal product in clinical development within 60 days prior to this trial.\n* Clinically significant abnormal haematology, biochemistry, urinalysis or coagulation screening tests, as judged by the Investigator considering the underlying disease\n* Supine blood pressure at screening outside the range of 90-160 mmHg for systolic or 50-95 mmHg for diastolic and/or resting supine heart rate outside the range 50-90 beats per minute. This exclusion criterion also pertains to subjects being on antihypertensives.\n* Current treatment with premixed or intermediate insulin products, or with long acting insulins other than insulin glargine U-100. The use of short or rapid acting prandial insulin products will be allowed provided their use has been stable for ≥ 3 months prior to screening.\n* Use of GLP-1 receptor agonists or oral antidiabetic drugs (OADs) other than stable intake of metformin alone or metformin in combination with a DPP-4 inhibitor within 4 weeks prior to screening\n* Women of child bearing potential not willing to use contraceptive methods.'}, 'identificationModule': {'nctId': 'NCT02915250', 'briefTitle': 'A Trial to Compare Post Prandial Blood Glucose Control of BioChaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adocia'}, 'officialTitle': 'A Randomised, Double-blind, Double-dummy, Three-period Cross-over Trial to Compare Post Prandial Blood Glucose Control of BioChaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'BC3-CT022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BioChaperone® Combo', 'description': 'Individualised single subcutaneous of BioChaperone® Combo + injection of placebo (0.9% NaCl) to ensure the double dummy', 'interventionNames': ['Drug: BioChaperone® Combo', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Humalog® Mix25', 'description': 'Individualised single subcutaneous of Humalog® Mix25 + injection of placebo (0.9% NaCl) to ensure the double dummy', 'interventionNames': ['Drug: Humalog® Mix25', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Humalog® and Lantus®', 'description': 'Individualised simultaneous subcutaneous injections', 'interventionNames': ['Drug: Humalog®', 'Drug: Lantus®']}], 'interventions': [{'name': 'BioChaperone® Combo', 'type': 'DRUG', 'description': 'Injection of BioChaperone® Combo', 'armGroupLabels': ['BioChaperone® Combo']}, {'name': 'Humalog® Mix25', 'type': 'DRUG', 'description': 'Injection of Humalog® Mix25', 'armGroupLabels': ['Humalog® Mix25']}, {'name': 'Humalog®', 'type': 'DRUG', 'description': 'Injection of Humalog®', 'armGroupLabels': ['Humalog® and Lantus®']}, {'name': 'Lantus®', 'type': 'DRUG', 'description': 'Injection of Lantus®', 'armGroupLabels': ['Humalog® and Lantus®']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Injection of 0.9% NaCl', 'armGroupLabels': ['BioChaperone® Combo', 'Humalog® Mix25']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55116', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Profil Mainz GmbH & Co.KG', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '41460', 'city': 'Neuss', 'country': 'Germany', 'facility': 'Profil GmbH', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'overallOfficials': [{'name': 'Leona Plum-Mörschel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Profil Mainz GmbH & Co KG'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adocia', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}