Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-01-24 @ 8:24 AM
Study NCT ID:
NCT02081118
Status:
COMPLETED
Last Update Posted:
2016-08-09
First Post:
2014-02-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycaemic Control of Monthly LAPS-Exendin Versus Placebo in Subjects of 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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 209}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'dispFirstSubmitDate': '2016-08-08', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-08', 'studyFirstSubmitDate': '2014-02-24', 'dispFirstSubmitQcDate': '2016-08-08', 'studyFirstSubmitQcDate': '2014-03-05', 'dispFirstPostDateStruct': {'date': '2016-08-09', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants with Adverse Events by HM11260C', 'timeFrame': 'Up to day 155'}, {'measure': 'Number of Participants with Immunogenicity by HM11260C', 'timeFrame': 'Up to day 155'}], 'primaryOutcomes': [{'measure': 'Change in baseline in glycosylated haemoglobin (HbA1c) at 16 weeks', 'timeFrame': 'Up to day 155'}], 'secondaryOutcomes': [{'measure': 'Fasting plasma glucose levels (FPG)', 'timeFrame': 'Up to day 155'}, {'measure': '7-point glucose profile', 'timeFrame': 'Up to day 155'}, {'measure': 'Serum lipid profile', 'timeFrame': 'Up to day 155'}, {'measure': 'Body weight', 'timeFrame': 'Up to day 155'}, {'measure': 'Fasting insulin', 'timeFrame': 'Up to day 155'}, {'measure': 'C-peptide', 'timeFrame': 'Up to day 155'}, {'measure': 'Glucagon', 'timeFrame': 'Up to day 155'}, {'measure': 'Glycated albumin', 'timeFrame': 'Up to day 155'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the optimal dose or doses of HM11260C, when administered once a month under the skin, to improve the control of blood sugar levels in patients with early-stage type 2 diabetes mellitus (T2DM).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages eligible for study : 18 years to 74 years\n* Genders eligible for study : Male and Female\n* Diagnosed with T2DM\n* Taking a stable dose of metformin monotherapy\n* HbA1c levels of between ≥ 7.0% and ≤ 10.0%\n* Females of childbearing potential who are not pregnant and agree to use a reliable method of birth control\n* Written informed consent must be obtained\n\nExclusion Criteria:\n\n* Pregnant or nursing (lactating) women\n* Diagnosis of type 1 diabetes mellitus\n* Uncontrolled diabetes defined as a FPG level of \\> 240 mg/dL at screening\n* A significant change in body weight in the 3 months before screening\n* Any history of GI intolerance\n* Personal or family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC\n* Known history of acute or chronic pancreatitis\n* A history of alcohol or drug abuse or drug addiction'}, 'identificationModule': {'nctId': 'NCT02081118', 'briefTitle': 'Glycaemic Control of Monthly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanmi Pharmaceutical Company Limited'}, 'officialTitle': 'A Phase II, 16-week, Double-blind, Placebo-controlled, Parallel-group, Randomised, Multicentre Trial to Assess Effect on Glycaemic Control of Three Doses of HM11260C in Subjects With Inadequately Controlled Type 2 Diabetes Receiving a Stable Dose of Metformin', 'orgStudyIdInfo': {'id': 'HM-EXC-204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HM11260C (8 mg)', 'description': 'Monthly administration of 8 mg of HMC11260C by subcutaneous injection for 16 weeks', 'interventionNames': ['Drug: HM11260C']}, {'type': 'EXPERIMENTAL', 'label': 'HM11260C (12 mg)', 'description': 'Monthly administration of 12 mg of HMC11260C by subcutaneous injection for 16 weeks', 'interventionNames': ['Drug: HM11260C']}, {'type': 'EXPERIMENTAL', 'label': 'HM11260C (16 mg)', 'description': 'Monthly administration of 16 mg of HMC11260C by subcutaneous injection for 16 weeks', 'interventionNames': ['Drug: HM11260C']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Monthly administration of placebo by subcutaneous injection for 16 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'HM11260C', 'type': 'DRUG', 'otherNames': ['LAPS-Exendin-4'], 'description': 'HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)', 'armGroupLabels': ['HM11260C (12 mg)', 'HM11260C (16 mg)', 'HM11260C (8 mg)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo for HM11260C', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Hanmi pharmaceutical', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanmi Pharmaceutical Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}