Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-02-03 @ 8:18 AM
Study NCT ID:
NCT00553020
Status:
COMPLETED
Last Update Posted:
2007-11-02
First Post:
2007-10-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Duration of Metabolic Effect of a Single Bolus of sc Injected Lantus Compared to NPH Insulin 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': 'D000069036', 'term': 'Insulin Glargine'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-10-31', 'studyFirstSubmitDate': '2007-10-31', 'studyFirstSubmitQcDate': '2007-10-31', 'lastUpdatePostDateStruct': {'date': '2007-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the duration of the metabolic effect of a sc injected single dose of either insulin glargine (LantusT) or NPH-insulin (ProtaphanT) on blood glucose control in patients with type 2 diabetes', 'timeFrame': 'during the study conduct'}], 'secondaryOutcomes': [{'measure': 'To evaluate the effect of insulin glargine (LantusT) and NPH-insulin (ProtaphanT) on suppression of endogenous glucose production, endogenous insulin secretion, and lipolysis', 'timeFrame': 'during the study conduct'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'To assess the duration of the metabolic effect of a sc injected single dose of either insulin glargine (LantusT) or NPH-insulin (ProtaphanT) on blood glucose control in patients with type 2 diabetes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes mellitus of either gender as defined by the American Diabetes Association (3) for more than 6 months\n* BMI (as defined in Appendix A of the protocol) between 28 kg/mý and 32 kg/mý (before implementation of Amendment 1) or between 26 kg/mý and 34 kg/mý (after implementation of Amendment 1)\n* Having required treatment with insulin for at least 6 months\n* Stable glycemic control with glycohemoglobin (HbA1c) \\>7.5% and \\<9.5% (before implementation of Amendment 1) or \\>7.0% and \\<9.5% (after implementation of Amendment 1\n* Fasting serum C-peptide \\>0.2 pmol/mL. According to Amendment 3, five additional subjects with "low" (defined as less than or equal to 0.4 pmol/mL) and 5 subjects with "high" (defined as \\>0.4 pmol/mL) fasting C-peptide were to be enrolled.\n* Negative pregnancy test in female subjects of childbearing potential (only for those who were not surgically sterile or who were less than 2 years postmenopausal) at the beginning of the study\n* No findings in medical history and physical examination (cardiovascular system, chest and lungs, thyroid, abdomen, nervous system, skin and mucosae, and muscular-skeletal system) which were clinically relevant and interfering with the conduct of the study\n* Normal ECG, blood pressure, pulse rate and core body temperature unless the investigator considered an abnormality to be clinically irrelevant and not interfering with the conduct of the study\n\nExclusion Criteria:\n\n* Subjects with "brittle" diabetes or predisposition to severe hypoglycemia, e.g. 2 or more severe hypoglycemic episodes (i.e. requiring assistance of another person) within the past year, or any hospitalization or emergency room visit due to poor diabetic control within the past 6 months\n* Subjects who had been treated with insulin with a total insulin dose of \\>1.5 IU/kg/day\n* Pregnant and nursing women\n* Female subjects of childbearing potential (those who are not surgically sterile or who are less than 2 years postmenopausal) unwilling or unable to use reliable contraceptive measures. Reliable contraceptive measures included the following: systemic contraceptive (oral, implant, injection), diaphragm with intravaginal spermicide, cervical cap, intrauterine device, or condom with spermicide.\n* Any condition requiring the regular use of any medication if the regular use of this medication interfered with the study conduct\n* Abuse of alcoholic beverages (as defined in Appendix B of the protocol)\n* Treatment with oral antidiabetic drugs within the last 4 weeks\n* Treatment in the previous 3 months with any drug known to have a well-defined potential for toxicity concerning vital organs\n* Symptoms of any major internal medical disease in the 4 weeks before the study which, according to the investigator\'s opinion, could interfere with the purposes of the study\n* History of hypersensitivity to any drugs that have a similar chemical structure to the study drug\n* History or presence of gastrointestinal, liver, or kidney disease or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs\n* Blood donation during the previous 3 months\n* Positive HIV- or hepatitis B/C-test\n* Progressive fatal disease\n\nThe above information is not intended to contain all considerations relevant to a patient\'s potential participation in a clinical trial.'}, 'identificationModule': {'nctId': 'NCT00553020', 'briefTitle': 'Assessment of Duration of Metabolic Effect of a Single Bolus of sc Injected Lantus Compared to NPH Insulin in Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Assessment of Duration of Metabolic Effect of a Single Bolus of Subcutaneous Injected Lantus Compared to NPH-Insulin(Protaphan)in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'HOE901_4050'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Insulin glargine', 'type': 'DRUG', 'description': 'Lantus (commercial formulation, Reference):\n\n10 mL vials (100 IU/mL) solution Dose: 0.3 IU per kg BW injected subcutaneously in the patients usual injection site (either abdomen or thigh)\n\nNPH-insulin (Protaphan) (Test):\n\n10 mL vials (100 IU/mL) solution Dose: 0.3 IU per kg BW injected subcutaneously in the patients usual injection site (either abdomen or thigh)'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Karim El-Haschimi', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}}}}