Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
Study NCT ID:
NCT00272012
Status:
COMPLETED
Last Update Posted:
2009-12-07
First Post:
2006-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
OPAL - Insulin Glulisine, Diabetes Mellitus
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': 'C479079', 'term': 'insulin glulisine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 396}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'lastUpdateSubmitDate': '2009-12-04', 'studyFirstSubmitDate': '2006-01-02', 'studyFirstSubmitQcDate': '2006-01-02', 'lastUpdatePostDateStruct': {'date': '2009-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c.', 'timeFrame': 'from baseline to study endpoint.'}], 'secondaryOutcomes': [{'measure': 'Change of pre-, 2 h postprandial and nocturnal blood glucose values', 'timeFrame': '8-point profile'}, {'measure': 'Fasting blood glucose', 'timeFrame': '8-point blood glucose profile values'}, {'measure': 'Responder rate HbA1c smaller 7 %', 'timeFrame': 'at study endpoint'}, {'measure': 'Insulin dose', 'timeFrame': 'rapid-acting, basal and total daily doses'}, {'measure': 'Weight, BMI', 'timeFrame': 'study follow-up'}, {'measure': 'Hypoglycemic events', 'timeFrame': 'study follow-up'}, {'measure': 'Adverse events.', 'timeFrame': 'study follow-up'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus Type 2']}, 'descriptionModule': {'briefSummary': 'Primary objective:\n\nThe primary study objective is to compare efficacy of Insulin glulisine, once a day at breakfast vs. Insulin glulisine given once a day at main meal in combination with insulin glargine + OAD in terms of change in HbA1c, from baseline to endpoint for the individual patient. The aim of the study is to demonstrate two-sided equivalence between the two therapy regimens receiving two different injection timing of Insulin glulisine.\n\nSecondary objective:\n\nSecondary study objectives are to compare efficacy and safety of Insulin glulisine, once a day at breakfast vs. Insulin glulisine given once a day at main meal in combination with insulin glargine + OAD in terms of:\n\n* Change of fasting-, pre-/2h-postprandial-, mean daily and nocturnal blood glucose (baseline to endpoint)\n* Change of fasting plasma glucose (baseline to endpoint)\n* Response rate: Responders will be those patients with HbA1c smaller than 7.0% at study endpoint\n* Insulin dose (rapid-acting, basal and total daily doses)\n* Weight, body-mass index\n* Hypoglycemic events\n* Adverse events'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Type 2 Diabetes mellitus, previously treated with combination therapy of insulin glargine + OAD (maximal tolerated dose / approved in combination with insulin according to local SPCs (Summary of Product Characteristics), not including use of a-glucosidase inhibitors) for at least 3 months\n* Pre-screening HbA1c value greater/equal 7% - smaller/equal 9%\n* FBG (Fasting Blood Glucose) smaller/equal 120 mg/dl (6.6 mmol/l)\n* Women are either not of childbearing potential (surgically sterile, or postmenopausal for more than 2 years) or are not pregnant and agree to use a reliable contraceptive measure for the duration of the study. Reliable contraceptive measures include the following: systemic contraceptive (oral, implant, injections), diaphragm with intravaginal spermicide, cervical cap, intrauterine device, or condom with spermicide.\n* Ability and willingness to perform blood glucose monitoring using the sponsor-provided blood glucose meter and subject diary at home\n\nExclusion criteria:\n\n* More than two FBG greater 120 mg/dl (6.6 mmol/l) as measured on 5 consecutive days before visit II\n* Active proliferative diabetic retinopathy, as defined by the application of focal or panretinal photocoagulation or vitrectomy, in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require surgical treatment (including laser photocoagulation)\n* Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult\n* Known impaired hepatic and renal function\n* History of drug or alcohol abuse\n* History of hypersensitivity to insulin or insulin analogues or any of the excipients in the Insulin glulisine formulation\n* Treatment with any investigational drug in the last month before visit I\n* Pregnant or breast-feeding women, or women planning to become pregnant during the study\n* Treatment or likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol\n* Night shift workers if they are unable to comply with the treatment regimen'}, 'identificationModule': {'nctId': 'NCT00272012', 'briefTitle': 'OPAL - Insulin Glulisine, Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Efficacy and Safety of Insulin Glulisine Given as a Single Injection at Breakfast + Insulin Glargine+OAD (Oral Antidiabetic Drug) vs Insulin Glulisine Given as a Single Injection at Main Meal+Insulin Glargine+OAD in Type 2 Diabetic Patients for Which Glycemic Control is Suboptimal Using Insulin Glargine+ OAD Alone', 'orgStudyIdInfo': {'id': 'HMR1964A_3507'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Insulin glulisine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Wolfgang Landgraf, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Heinz Riederer / Medical Director', 'oldOrganization': 'Sanofi-aventis Germany'}}}}