Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT01630369
Status:
COMPLETED
Last Update Posted:
2014-05-19
First Post:
2012-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Insuman Basal/Comb/Rapid in 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': 'D007328', 'term': 'Insulin'}], 'ancestors': [{'id': 'D011384', 'term': 'Proinsulin'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 552}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-16', 'studyFirstSubmitDate': '2012-06-26', 'studyFirstSubmitQcDate': '2012-06-26', 'lastUpdatePostDateStruct': {'date': '2014-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decrease of Hb A1c ≥ 1%', 'timeFrame': 'Baseline, 6 months'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients with Hb A1c < 7.5%', 'timeFrame': '6 months'}, {'measure': 'Rate of hypoglycaemias (symptomatic, severe)', 'timeFrame': '6 months'}, {'measure': 'Middle dose of insulin per product (Insuman Basal, Insuman Comb, Insuman Rapid)', 'timeFrame': '6 months'}, {'measure': 'Change in FPG', 'timeFrame': 'Baseline 6 months'}, {'measure': 'Number of patients with adverse events', 'timeFrame': '6 months'}, {'measure': 'Assessment of efficacy of education courses in Diabetes Schools', 'timeFrame': 'Baseline, 6 months', 'description': 'Percentage of correct answers after second test compare to the testing of the initial level'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\n\\- To evaluate the decrease of Hb A1c ≥ 1% after 6 month treatment in patients with Type 2 Diabetes Mellitus (T2DM) uncontrolled on Oral Antidiabetics (OADs)\n\nSecondary Objectives:\n\n* To evaluate the percentage of patients with Hb A1c \\< 7.5%,\n* To evaluate the rate of hypoglycaemia (symptomatic, severe)\n* To evaluate the middle dose of insulin per product - Insuman Basal, Insuman Comb, Insuman Rapid after 6 month treatment\n* To evaluate the change in Fasting Plasma Glucose (FPG) after 6 month treatment\n* To assess the overall safety\n* To evaluate the efficacy of education courses in Diabetes Schools (% of correct answers after second test compare to the testing of the initial level)', 'detailedDescription': '6 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria :\n\n* T2DM patients uncontrolled by maximum tolerated dose of 1-2 OADs\n* Males and Female \\> 18 years\n* HbA1c \\> 7.5%\n* Patients with abilities of self-monitoring of Diabetes, managing of patient's diary, ability to obtain education in Diabetes School, completion of Questionnaire\n* It is expected that the patient will remain on a stable dose of OADs within 6 months of treatment\n\nExclusion criteria :\n\n* Type 1 diabetes\n* Current temporary insulin therapy (gestational diabetes, pancreas cancer, surgery, clinical trial)\n* Any clinically significant acute major organ or systemic diseases making interpretation of the evaluation results difficult\n* Patient planning a pregnancy now or in the next 6 months\n* The patient is participating in another clinical study now or in the last 28 days prior to Visit 1\n* The patient is a drug user (currently or in the past)\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01630369', 'acronym': 'SPIRIT', 'briefTitle': 'Efficacy and Safety of Insuman Basal/Comb/Rapid in Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Multicenter, Open, Non-randomized 6 Months Study to Evaluate Efficacy and Safety Insuman® Basal, Insuman® Comb 25, Insuman® Rapid in Insulin-naÏve Patients With T2DM Who Received Baseline Education Course in the Diabetes School.', 'orgStudyIdInfo': {'id': 'HUBIN_L_05574'}, 'secondaryIdInfos': [{'id': 'U1111-1128-8605', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Human Insulin', 'description': 'Dosage of human insulin (Insuman Basal/Comb/Rapid) will be individually adjusted in accordance with the Summary of Product Characteristics (SmPC). Patients will follow the titration algorithm recommended by the physician.', 'interventionNames': ['Drug: insulin human (HR1799)']}], 'interventions': [{'name': 'insulin human (HR1799)', 'type': 'DRUG', 'otherNames': ['Insuman Basal / Insuman Comb / Insuman Rapid'], 'description': 'Pharmaceutical form: solution for injection Route of administration: subcutaneous', 'armGroupLabels': ['Human Insulin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}