Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-01-22 @ 6:08 PM
Study NCT ID:
NCT01720303
Status:
COMPLETED
Last Update Posted:
2017-02-20
First Post:
2012-10-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Repaglinide Combined With Insulin in Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C072379', 'term': 'repaglinide'}, {'id': 'D007336', 'term': 'Insulin, Isophane'}, {'id': 'D007328', 'term': 'Insulin'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-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': 'D011384', 'term': 'Proinsulin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 159}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2003-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-17', 'studyFirstSubmitDate': '2012-10-31', 'studyFirstSubmitQcDate': '2012-10-31', 'lastUpdatePostDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c'}], 'secondaryOutcomes': [{'measure': 'Change in FBG (Fasting Blood Glucose)'}, {'measure': 'Change in body weight'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Asia. The aim of this trial is to compare oral anti-diabetic drug (OAD) combined with insulin vs. insulin alone in subjects with type 2 diabetes not adequately controlled on the current OAD therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HbA1c between 7.5 % and 13.0% (both inclusive)\n* Fasting C-peptide above or equal to 0.33 nmol/l\n* BMI (Body Mass Index) between 25 and 32 kg/m2 (both inclusive)\n\nExclusion Criteria:\n\n* Medical history of treatment with insulin within the last 6 months\n* Impaired renal function, defined as serum creatinine above to 1.7 mg/dl (150 µmol/l)'}, 'identificationModule': {'nctId': 'NCT01720303', 'briefTitle': 'Efficacy and Safety of Repaglinide Combined With Insulin in Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Multi-centre, Open, Randomised, Parallel, Controlled Trial to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime Insulin With Insulin Alone in Type 2 Diabetic Subjects Inadequately Controlled With Sulphonylurea ± Biguanide Therapy', 'orgStudyIdInfo': {'id': 'AGEE-3020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rep + NPH', 'interventionNames': ['Drug: repaglinide', 'Drug: isophane human insulin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Premixed insulin/NPH', 'interventionNames': ['Drug: insulin']}], 'interventions': [{'name': 'repaglinide', 'type': 'DRUG', 'description': '2 mg (tablets) before each main meal', 'armGroupLabels': ['Rep + NPH']}, {'name': 'isophane human insulin', 'type': 'DRUG', 'description': 'Injection s.c. (under the skin) at bedtime', 'armGroupLabels': ['Rep + NPH']}, {'name': 'insulin', 'type': 'DRUG', 'description': 'Injection s.c. (under the skin) twice daily', 'armGroupLabels': ['Premixed insulin/NPH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100101', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}