Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-01-13 @ 1:24 PM
Study NCT ID:
NCT00511732
Status:
COMPLETED
Last Update Posted:
2012-04-30
First Post:
2007-08-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
18-Week, Randomized, Double-blind, Placebo Controlled, Forced Titration Study of 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 227}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-27', 'studyFirstSubmitDate': '2007-08-03', 'studyFirstSubmitQcDate': '2007-08-03', 'lastUpdatePostDateStruct': {'date': '2012-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c change from baseline (week 6) to end of treatment (week 17)', 'timeFrame': 'measured from week 6 (baseline) to week 17'}, {'measure': 'Area under the plasma glucose concentration versus time (AUCglucose) compared to week 6 (baseline.', 'timeFrame': 'at weeks 4, 6, 11 and 17', 'description': 'Timepoints: 0 minutes (before meal) and at 15, 30, 60, 90, 120, 180, 240, and 300 minutes after TI administration'}, {'measure': 'Area under the plasma glucose concentration versus time (AUCglucose) compared to week 6 (baseline)', 'timeFrame': 'at weeks 4, 6, 11 and 17', 'description': 'Timepoints: 0 minutes (before meal) and at 15, 30, 60, 90, 120, 180, 240, and 300 minutes after Technosphere Placebo administration'}], 'secondaryOutcomes': [{'measure': 'Fasting blood glucose concentration compared to week 6 (baseline)', 'timeFrame': 'at weeks 4, 6, 11 and 17'}, {'measure': 'Safety variables included adverse events (AEs), clinical laboratory tests, vital signs and physical examinations', 'timeFrame': '18 weeks'}]}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Designed to evaluate dose response of force-titrated prandial administration of TI as compared to placebo (TP) in subjects with Type 2 diabetes who were suboptimally controlled'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and females patients from 18 to \\<80 years of age\n* Clinical diagnosis of type 2 diabetes mellitus\n* Duration of diabetes of \\>3 years and \\<20 years\n* Glycemic control at upper end of acceptable level or sub-optimal in control (HbA1c between 7.0% and 12?0%)\n* Confirmation of diagnosis of diabetes such as a history of 2 hour postprandial blood glucose \\>11.1 mmol/L (200 mg/dL) or following a glucose tolerance test\n* A minimum of 2 months of treatment with a stable dose of one or more of the following anti-hyperglycemic agents: sulphonylureas, alpha glucosidase inhibitors, metformin, meglitinides, thiazolidinediones and/or Lantus basal insulin therapy\n* FBG:\\>6 mmol/L (108 mg/dL)\n* C-peptide: \\>0.5 nmol/L\n* BMI \\<38 kg/m2\n* Baseline DLco, FVC, FEV1 \\>75% of predicted normal\n* Subjects who, in the opinion of the Investigator, will be able to complete this study\n* Written informed consent\n\nExclusion Criteria:\n\n* Severe complications of diabetes including history of: blindness from or grade III or IV diabetic retinopathy, renal failure requiring dialysis or transplantation, amputation of limbs or digits related to diabetic vasculopathy or foot ulcers\n* Treatment with another investigational drug within 3 months prior to study entry and for the duration of the study\n* History of drug or alcohol dependency\n* Significant hepatic disease (as evidenced by ALT or AST \\>3 times the normal upper reference range or bilirubin \\>1.5 times the normal upper reference range)\n* Significant renal disease (as evidenced by creatinine \\>1.5 mg/dL for males or \\>1.3 mg/dL for females) or proteinuria \\>1,000 mg/24 hours\n* History of chronic obstructive pulmonary disease, or history of other known chronic pulmonary diseases, such as reactive airway disease, chronic bronchitis, emphysema, or asthma\n* Heart disease graded as class III or class IV according to New York Heart Association criteria\n* Prior treatment with , or participation in a clinical study involving an inhaled insulin product\n* Smokers\n* Current use of preprandial or prandially administered fast-acting or rapid acting insulin or insulin analogs\n* Previous participation in a TI or TP clinical trial\n* Allergy to insulin or to any drugs to be used as part of the clinical trial\n* History of malignancy within 5 years of study entry (other than basal cell carcinoma)\n* Anemia (hemoglobin level less than 11 g/dL for females or 12 g/dL for males at study entry)\n* Diagnosis of Acquired Immunodeficiency Syndrome (AIDS) and Aids Related Complex A major psychiatric disorder that will preclude satisfactory participation in this study\n* Subjects who have had a myocardial infarction or stroke within the preceding 6 months\n* Prior diagnosis of systemic autoimmune or collagen vascular disease requiring previous or current treatment with systemic corticosteroids, cytotoxic drugs, or penicillamine\n* History of severe or multiple allergies\n* Progressive fatal disease\n* Recent loss (within the past 2 months) of \\>5% of body weight\n* Evidence of "moderate" or greater ketones in urine or history of ketoacidosis\n* Use of medications known to modify glucose metabolism or the ability to recover from hypoglycemia such as oral, parenteral and inhaled steroids, or greater than 25 mg hydrochlorothiazide daily\n* Women who are pregnant or lactating\n* Women of childbearing potential practicing inadequate birth control (adequate birth control is defined as using oral contraceptives, condoms or diaphragms with spermicide, intrauterine devices, or surgical sterilization).'}, 'identificationModule': {'nctId': 'NCT00511732', 'briefTitle': '18-Week, Randomized, Double-blind, Placebo Controlled, Forced Titration Study of Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mannkind Corporation'}, 'officialTitle': 'A Randomized, Double-blind, Controlled, Stepwise Titration Study to Evaluate Dose Response to Prandial Administration of Inhaled Technosphere/Insulin or Technosphere in Patients With Type 2 Diabetes Mellitus Who Are Sub-optimally Treated', 'orgStudyIdInfo': {'id': 'MKC-TI-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Technosphere Insulin', 'interventionNames': ['Drug: Technosphere Insulin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Technosphere Inhalation Powder', 'interventionNames': ['Drug: Technosphere Placebo']}], 'interventions': [{'name': 'Technosphere Insulin', 'type': 'DRUG', 'description': 'Technosphere Insulin Inhalation Powder', 'armGroupLabels': ['Technosphere Insulin']}, {'name': 'Technosphere Placebo', 'type': 'DRUG', 'description': 'Technosphere Inhalation Powder', 'armGroupLabels': ['Technosphere Inhalation Powder']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Anders Boss', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mannkind Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mannkind Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}