Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:11 PM
Study NCT ID:
NCT01140893
Status:
UNKNOWN
Last Update Posted:
2016-08-23
First Post:
2010-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Exenatide on Glycemic Control and Weight in Continuous Subcutaneous Insulin Infusion (CSII) Type 2 Treated Patients 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': 'D000077270', 'term': 'Exenatide'}], 'ancestors': [{'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014688', 'term': 'Venoms'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'lastUpdateSubmitDate': '2016-08-22', 'studyFirstSubmitDate': '2010-05-03', 'studyFirstSubmitQcDate': '2010-06-09', 'lastUpdatePostDateStruct': {'date': '2016-08-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline to 6 months of centrally measured HbA1c', 'timeFrame': 'baseline to 6 months'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in weight, BMI, waist circumference, 6 points glucose profile, insulin doses, % of daily use of insulin as basal rate, % of daily use of insulin as bolus, quality of life questionnaire', 'timeFrame': 'baseline to 6 months'}, {'measure': 'Change from baseline in mean blood glucose value', 'timeFrame': 'baseline to 6 months', 'description': 'occurrence of hyperglycemia above 190 mg/dl expressed as Area under the Curve (high) above 190 mg/dl (10.5 mmol/l), occurrence of hypoglycemia below 70 mg/dl (3.9 mmol/l) expressed as Area Under the Curve (low) below 70 mg/dl, glycemic variability (MAGE index).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Type 2 diabetes', 'CSII', 'Exenatide', 'Double Blind Placebo Controlled Study'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether exenatide is effective to improve glycemic control among type 2 diabetic patients treated by insulin pump therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women aged 35 to 70\n* Type 2 diabetes diagnosed for at least 12 months, according the criteria of the American Diabetes Association :\n\n * presence of classic symptoms of diabetes mellitus with unequivocal elevation of plasma glucose (2-hour post-prandial or random glucose \\>200 mg/dL) or\n * fasting plasma glucose elevation on more than 1 occasion \\> 125 mg/dL or\n * patient currently undergoing pharmacological and/or non-pharmacological treatment for diabetes mellitus\n* CSII treatment using a rapid analog for at least 6 month (CSII being initiated in patients with HbA1c \\> 8 % despite a well-conducted MDI trial using a 2 to 5 daily injection regimen)\n* HbA1c ≥ 7,5% and ≤ 10 %\n* BMI ≥ 25 and ≤ 45\n* Stable body weight (≤10% variation) during the 3 last months\n\nExclusion Criteria:\n\n* Type 1 diabetes assessed by positive anti-GAD65 or anti-insulin or anti-IA2 antibodies\n* Monogenic diabetes (MODY, mitochondrial diabetes…)\n* Current treatment with OHA (OHA ought to be interrupted at least two months prior to inclusion in the study)\n* Current treatment specifically addressed for weight lost (orlistat, sibutramine, rimonabant may be interrupted at least 3 months prior to inclusion in the study)\n* Use of corticosteroid therapy for more than 10 days within the 3-past months, or patient who ought to be treated by corticosteroid during the study period\n* Clinically significant hepatic disease\n* Documented gastroparesis, or current use of drugs that directly affect gastrointestinal motility, or any significant abdominal disease that may increase the risk of adverse gastrointestinal effects induced by exenatide\n* Kidney failure (MDRD less than 50 ml/min)\n* Pregnancy/breastfeeding\n* Any social and/or mental condition rendering the subject unable to understand the scope and possible consequences of the study\n* Concurrent enrolment in another clinical trial\n* Geographically inaccessible for follow-up visits required by protocol'}, 'identificationModule': {'nctId': 'NCT01140893', 'acronym': 'EXEPUMP', 'briefTitle': 'Effects of Exenatide on Glycemic Control and Weight in Continuous Subcutaneous Insulin Infusion (CSII) Type 2 Treated Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Effects of EXEnatide on Glycemic Control and Weight Over 26 Weeks in Continuous Subcutaneous Insulin Infusion (CSII) Treated Patients With Type 2 Diabetes : a Phase 2/3 Double Blind randoMized Placebo-controlled Trial.', 'orgStudyIdInfo': {'id': 'EudraCT N° 2009-016384-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'exenatide', 'description': '55 subjects', 'interventionNames': ['Drug: Exenatide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '55 subjects', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Exenatide', 'type': 'DRUG', 'otherNames': ['Exenatide = BYETTA (R)'], 'description': 'Research drug (exenatide or placebo), will begin at V0, after randomization. The initial dosage for the first month will be 5 µg SC BID. Injections can be administered at any time within the 60 minute period before the morning and evening meal.\n\nFrom V1, research drug will be titrated from 5 to 10 µg SC BID. If gastro-intestinal adverse effects occur with 10 µg SC BID, the dosage will be back-titrated to 5 µg SC BID. Thus, the higher research drug dosage tolerated will be used during the study time.', 'armGroupLabels': ['exenatide']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'role': 'CONTACT', 'phone': '+33 2 31 06 45 75'}, {'name': 'Michael JOUBERT, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yves REZNIK, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Corbeil-Essonne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume Charpentier, MD', 'role': 'CONTACT'}], 'facility': 'CERIDT'}, {'city': 'Strasbourg', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nathalie Jeandidier, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Endocrinology Unit', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Michael Joubert, MD', 'role': 'CONTACT', 'email': 'joubert-m@chu-caen.fr'}, {'name': 'Yves Reznik, MD', 'role': 'CONTACT', 'email': 'reznik-y@chu-caen.fr'}], 'overallOfficials': [{'name': 'Michael JOUBERT, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Endocrinology Unit, University Hospital of Caen, FRANCE'}, {'name': 'Yves REZNIK, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Endocrinology Unit, University Hospital of Caen, FRANCE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}