Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 12:07 AM
Study NCT ID:
NCT00814294
Status:
COMPLETED
Last Update Posted:
2021-05-26
First Post:
2008-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Two Doses of Oral HDV-Insulin and Placebo With Background Metformin Treatment in Patients With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 239}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'dispFirstSubmitDate': '2021-05-03', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-24', 'studyFirstSubmitDate': '2008-12-23', 'dispFirstSubmitQcDate': '2021-05-03', 'studyFirstSubmitQcDate': '2008-12-23', 'dispFirstPostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective of this trial is to compare the reduction in mean glycated hemoglobin levels (HbA1c) between 2 doses of oral HDV-I and placebo in type 2 diabetic patients on background metformin therapy at the end of 18 weeks of treatment.', 'timeFrame': '18 weeks'}], 'secondaryOutcomes': [{'measure': 'To evaluate the effects of oral HDV-I versus placebo on the 7-point glucose test', 'timeFrame': '18 weeks'}, {'measure': 'To evaluate the effects of oral HDV-I versus placebo on fasting plasma glucose (FPG) and insulin', 'timeFrame': '18 weeks'}, {'measure': 'To evaluate the effects of oral HDV-I versus placebo on the homeostasis model assessment of insulin resistance (HOMA-IR)and homeostasis model assessment of β-cell function (HOMA-β)', 'timeFrame': '18 Weeks'}, {'measure': 'To evaluate the effects of oral HDV-I versus placebo on frequency of hypoglycemic events, body weight, and lipid levels', 'timeFrame': '18 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial is to compare the reduction in mean glycated hemoglobin levels (HbA1c) between 2 doses of oral HDV-I and placebo in type 2 diabetic patients on background metformin therapy at the end of 18 weeks of treatment.\n\nThe secondary objectives are:\n\n* To evaluate the effects of oral HDV-I versus placebo on the 7-point glucose test, fasting plasma glucose (FPG), insulin, homeostasis model assessment of insulin resistance (HOMA-IR), homeostasis model assessment of β-cell function (HOMA-β), frequency of hypoglycemic events, body weight, and lipid levels; and\n* To evaluate the safety and tolerability of oral HDV-I.', 'detailedDescription': 'This is a multicenter, randomized, double-blind, placebo-controlled study with a washout/stabilization period of up to 12 weeks in duration and an 18-week double-blind treatment period. There will be a total of 8 visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 70 years, inclusive;\n* Diagnosis of type 2 diabetes mellitus;\n* Fasting plasma glucose \\<=250 mg/dL;\n* BMI \\<=45 kg/m2;\n* HbA1c levels as follows at Screening:\n* On a stable dose of metformin monotherapy with an HbA1c \\>=7.5% and \\<=9.5%;\n* On metformin and 1 other OAD (excluding TZD, exenatide, or insulin) with an HbA1c \\>=6.8% and \\<=9.0%;\n* Naïve to antidiabetic therapy or have not been on a stable dose of metformin monotherapy for \\<12 weeks with an HbA1c \\>=8.0% and \\<=10.5%;\n* Understanding of the study procedures and agreement to participate in the study, giving written informed consent;\n* Women may be enrolled if all of the following criteria (in addition to the above criteria) are met:\n* They are not pregnant (women of childbearing potential must have a negative serum pregnancy test at Visit 1);\n* They are not breast-feeding;\n* They do not plan to become pregnant during the study; and\n* They have had a hysterectomy or tubal ligation 6 months prior to the study, have been post-menopausal for 1 year, or will practice a method of birth control throughout the study.\n\nExclusion Criteria:\n\n* History of type 1 diabetes and/or history of ketoacidosis;\n* History of chronic (\\>2 months) use of insulin therapy or recent initiation of insulin use intended for chronic administration;\n* Use of TZD (pioglitazone or rosiglitazone) or exenatide within 3 months prior to Screening;\n* Use of prescription or over the counter weight loss agents within 1 month prior to Screening;\n* Use of any lipid-altering, antihypertensive, and other chronic use medication not stable for 1 month prior to Screening;\n* Use of any medication that may alter blood glucose analyses;\n* Any serious disorder including cardiac, pulmonary, hepatic, uncontrolled endocrine/metabolic, hematologic/oncologic (within the last 5 years), neurologic, and psychiatric diseases that would interfere with the conduct of the study or interpretation of the data;\n* Require regular use of medication that interferes with the oral absorption and/or metabolism of insulin or metformin;\n* History of pancreatitis;\n* History of acquired immune deficiency syndrome or human immunodeficiency virus;\n* History of drug or alcohol abuse within the past 2 years;\n* Hospitalization for any cause within 14 days prior to the study;\n* History of an allergic or toxic response to oral HDV-I;\n* Uncontrolled hypertension: systolic blood pressure \\>160 mmHg and diastolic blood pressure \\>95 mmHg;\n* Triglycerides \\>400 mg/dL;\n* Aspartate aminotransferase or alanine aminotransferase \\>2.5 times the upper limit of normal (ULN);\n* Creatine phosphokinase \\>3 times the ULN;\n* Patients on a weight loss program with ongoing weight loss, or starting an intensive exercise program within 4 weeks of starting the study;\n* Use of any investigational drug within 30 days preceding the first dose of study medication; or\n* Employment by the research center.'}, 'identificationModule': {'nctId': 'NCT00814294', 'briefTitle': 'Study of Two Doses of Oral HDV-Insulin and Placebo With Background Metformin Treatment in Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Diasome Pharmaceuticals'}, 'officialTitle': 'An 18-Week Randomized, Double-Blind, Multicenter, Comparator Study of Two Doses of Oral HDV-Insulin and Placebo With Background Metformin Treatment in Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'DP 01-2007-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1; Placebo', 'description': 'Patients receive a sugar pill.', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': '2; Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5)', 'description': 'Patients receive Oral HDV-Insulin (U-5).', 'interventionNames': ['Drug: Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5)']}, {'type': 'EXPERIMENTAL', 'label': '3; Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15)', 'description': 'Patients receive Oral HDV-Insulin (U-15).', 'interventionNames': ['Drug: Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15)']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'description': 'placebo capsule,0 units, quater in die (QID) for 18 weeks', 'armGroupLabels': ['1; Placebo']}, {'name': 'Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15)', 'type': 'DRUG', 'description': 'Oral HDV-I Caps; 15 U; quater in die (QID) for 18 weeks.', 'armGroupLabels': ['3; Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15)']}, {'name': 'Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5)', 'type': 'DRUG', 'description': 'Oral HDV-I; Caps; 5 U; quater in die (QID) for 18 weeks.', 'armGroupLabels': ['2; Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35661', 'city': 'Muscle Shoals', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.74481, 'lon': -87.66753}}, {'zip': '85340', 'city': 'Litchfield Park', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.49337, 'lon': -112.35794}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '90723', 'city': 'Paramount', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.88946, 'lon': -118.15979}}, {'zip': '95825', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94401', 'city': 'San Mateo', 'state': 'California', 'country': 'United 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