Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2026-01-03 @ 8:24 PM
Study NCT ID:
NCT02514850
Status:
COMPLETED
Last Update Posted:
2015-12-02
First Post:
2015-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to Compare the Pharmacodynamic and Pharmacokinetic Properties 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': 'C482266', 'term': 'insulin lispro, isophane insulin lispro drug combination (25:75)'}, {'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', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-30', 'studyFirstSubmitDate': '2015-07-29', 'studyFirstSubmitQcDate': '2015-07-31', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the glucose infusion rate curve (AUCGIR) 12-30h (mg/kg)', 'timeFrame': 'from 12h to 30 hours', 'description': 'Area under the glucose infusion rate curve from 12 hours to 30 hours'}], 'secondaryOutcomes': [{'measure': 'AUCGIR 0-last (mg/kg)', 'timeFrame': 'Up to 30 hours', 'description': 'Area under the glucose infusion rate curve from 0 hours until the end of clamp'}, {'measure': 'GIRmax (mg/kg/min)', 'timeFrame': 'Up to 30 hours', 'description': 'Maximum glucose infusion rate'}, {'measure': 'tGIRmax', 'timeFrame': 'Up to 30 hours', 'description': 'Time to maximum glucose infusion rate'}, {'measure': 'AUCLis 0-30h', 'timeFrame': 'Up to 30 hours', 'description': 'Area under the insulin lispro plasma concentration time curve'}, {'measure': 'AUCGla 0-30h', 'timeFrame': 'Up to 30 hours', 'description': 'Area under the insulin glargine plasma concentration time curve'}, {'measure': 'tmax Gla', 'timeFrame': 'Up to 30 hours', 'description': 'Time to maximum insulin glargine plasma concentration'}, {'measure': 'tmax Lis', 'timeFrame': 'Up to 30 hours', 'description': 'Time to maximum insulin lispro plasma concentration'}, {'measure': 'Adverse events', 'timeFrame': 'Up to 9 weeks', 'description': 'Number of adverse events'}, {'measure': 'Hypoglycaemic episodes', 'timeFrame': 'Up to 9 weeks', 'description': 'Number of Hypoglycaemic episodes'}, {'measure': 'Local tolerability', 'timeFrame': 'Up to 9 weeks', 'description': 'Number and intensity of injection site reactions'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This is a single centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over, euglycaemic clamp study in subjects with type 2 diabetes on stable insulin treatment. Each subject will be randomly allocated to a treatment sequence and will be administered single subcutaneous doses of 0.8 U/kg Biochaperone® Combo, 0.8 U/kg Humalog® Mix25 or simultaneous subcutaneous injections of 0.2 U/kg Humalog® and 0.6 U/kg Lantus® during three separate dosing visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months\n* HbA1c levels ≤ 9.0%\n* Total insulin dose of \\< 1.2 U/kg/day\n* Body mass index between 20.0 and 35.0 kg/m2 (both inclusive)\n* Body weight ≤ 125.0 kg\n* Fasting serum C-peptide ≤ 1 nmol/L\n* Treated with a stable insulin regimen for ≥ 3 months prior to screening\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus\n* Known or suspected allergy to the trial products or related products\n* Previous participation in this trial. Participation is defined as randomised\n* Participation in any clinical trial within 3 months prior to this trial\n* Clinically significant abnormal haematology, biochemistry, lipids, or urinalysis 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* Use of GLP-1 receptor agonists or oral antidiabetic drugs (OADs) other than stable intake of metformin within 4 weeks prior to screening\n* Women of child bearing potential, not willing to use contraceptive methods'}, 'identificationModule': {'nctId': 'NCT02514850', 'briefTitle': 'A Trial to Compare the Pharmacodynamic and Pharmacokinetic Properties 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, Single Dose, Double-blind, Double-dummy, Three-period Cross-over Trial to Compare the Pharmacodynamic and Pharmacokinetic Properties of Biochaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'BC3-CT018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biochaperone Combo', 'description': 'single subcutaneous injection of 0.8 U/kg + injection of placebo (0.9% NaCl) to ensure the double dummy', 'interventionNames': ['Drug: Biochaperone Combo', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Humalog Mix25', 'description': 'single subcutaneous dose of 0.8 U/kg + 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': 'simultaneous subcutaneous injections of 0.2 U/kg Humalog and 0.6 U/kg Lantus', '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 saline 0.9% solution', 'armGroupLabels': ['Biochaperone Combo', 'Humalog Mix25']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41460', 'city': 'Neuss', 'country': 'Germany', 'facility': 'Profil Institut für Stoffwechselforschung GmbH', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'overallOfficials': [{'name': 'Ulrike Hövelmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Profil Institut Für Stoffwechselfforschung GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adocia', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}