Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-25 @ 3:45 PM
Study NCT ID:
NCT00971659
Status:
COMPLETED
Last Update Posted:
2009-09-04
First Post:
2009-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjunctive Therapy of Exenatide or Sitagliptin to Insulin Glargine in 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'}, {'id': 'D000077270', 'term': 'Exenatide'}, {'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}], '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'}, {'id': 'D014688', 'term': 'Venoms'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-03', 'studyFirstSubmitDate': '2009-09-03', 'studyFirstSubmitQcDate': '2009-09-03', 'lastUpdatePostDateStruct': {'date': '2009-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the unadjusted 6-hour postprandial blood glucose excursion (AUCBG0-6h) following ingestion of a standardized breakfast', 'timeFrame': 'after 4 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'mean daily blood glucose (BG) from 7-point 24h BG profiles, fasting BG, self-measured 7-point BG profiles, percentage of subjects achieving ADA HbA1c treatment goals, fasting lipid profiles, HOMA-IR index, hypoglycemic episodes', 'timeFrame': 'after 4 weeks of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['type 2 diabetes'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '20357372', 'type': 'DERIVED', 'citation': 'Arnolds S, Dellweg S, Clair J, Dain MP, Nauck MA, Rave K, Kapitza C. Further improvement in postprandial glucose control with addition of exenatide or sitagliptin to combination therapy with insulin glargine and metformin: a proof-of-concept study. Diabetes Care. 2010 Jul;33(7):1509-15. doi: 10.2337/dc09-2191. Epub 2010 Mar 31.'}]}, 'descriptionModule': {'briefSummary': 'This study investigated a 4-week adjunctive therapy of either a GLP-1 analog (exenatide), or a DPP-4 inhibitor (sitagliptin), given to a basal insulin analog (insulin glargine), and their effect on blood glucose control, versus insulin glargine alone as active comparator in type 2 diabetes.', 'detailedDescription': 'Due to the different mechanisms of action of the long-acting insulin analog insulin glargine and both a GLP-1 analog (exenatide) and a DPP-4-inhibitor (sitagliptin), it could be a promising approach to combine insulin glargine with either exenatide or sitagliptin for optimum control of fasting and postprandial blood glucose values. Thus, in the present study the influence of either exenatide or sitagliptin as a 4-week adjunctive therapy to a basal insulin (insulin glargine) was investigated versus insulin glargine alone as active comparator in subjects with type 2 diabetes. Preexisting metformin was continued, sulfonylureas, if any, were stopped. In particular, the effects on postprandial blood glucose excursion following ingestion of a standard breakfast, assessed after 4 weeks of treatment, the effects on mean daily blood glucose, on self-measured 7-point profiles, the percentage of subjects reaching ADA treatment goals (HbA1c \\< 7.0%) at the end of treatment, on fasting lipid profile, on HOMA index, weight, hypoglycemic episodes and general safety were assessed. The study consisted of a screening visit, a 4-8 week (depending on pre-treatment) run-in period, a 4-week treatment period, and a follow-up visit. There were weekly visits at the site and twice weekly telephone contacts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female subjects aged between 35 and 70 years, inclusive\n* type 2 diabetes with duration \\>6 months and \\<10 years\n* for at least 3 months: treatment solely with a long- or intermediate-acting insulin formulation (insulin glargine, insulin detemir, or NPH insulin) with or without a stable dose of metformin or treatment solely with a stable dose of metformin or combination of stable doses of metformin plus sulfonylureas\n* HbA1c \\>=7.0% and \\<=10.0%\n* if treated with antihypertensive or lipid lowering agents, the treatment regimen had to be stable during 3 months prior to study start\n* written informed consent\n\nExclusion Criteria:\n\n* history or presence of cancer or any clinically relevant diseases\n* chronic heart failure NYHA class III or IV, unstable angina pectoris or myocardial infarction within the previous 6 months\n* recurrent hypoglycemia\n* abnormal lab tests at screening (ALAT and/or ASAT \\>=3 times ULN), creatinine \\>1.6 mg/dL in males and \\>1.4 mg/dL in females\n* clinically relevant ECG findings at screening\n* treatment with a rapid-acting insulin or with a mixed insulin formulation during the previous 3 months\n* treatment with any other OHA than metformin or metformin plus sulfonylureas during the previous 3 months\n* any systemic or topical treatment with drugs known to influence glucose metabolism'}, 'identificationModule': {'nctId': 'NCT00971659', 'briefTitle': 'Adjunctive Therapy of Exenatide or Sitagliptin to Insulin Glargine in Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Profil Institut für Stoffwechselforschung GmbH'}, 'officialTitle': 'Acute Effect of a GLP-1-Analogue (Exenatide) and of a DPP-4-Inhibitor (Sitagliptin) in Subjects With Type 2 Diabetes Treated With Insulin Glargine Once Daily', 'orgStudyIdInfo': {'id': '49/0316-Adjunct'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'insulin glargine + exenatide + metformin', 'interventionNames': ['Drug: insulin glargine + exenatide + preexisting metformin']}, {'type': 'EXPERIMENTAL', 'label': 'Insulin glargine + sitagliptin + metformin', 'interventionNames': ['Drug: insulin glargine + sitagliptin + preexisting metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'insulin glargine + metformin', 'interventionNames': ['Drug: insulin glargine + preexisting metformin']}], 'interventions': [{'name': 'insulin glargine + exenatide + preexisting metformin', 'type': 'DRUG', 'otherNames': ['Lantus', 'Byetta'], 'description': 'insulin glargine once daily subcutaneously over 4 weeks, dose adjustment according to a treat-to-target algorithm, exenatide 5ug twice daily subcutaneously for 2 weeks, then 10ug twice daily for 2 weeks, continuation of preexisting metformin', 'armGroupLabels': ['insulin glargine + exenatide + metformin']}, {'name': 'insulin glargine + sitagliptin + preexisting metformin', 'type': 'DRUG', 'otherNames': ['Lantus', 'Januvia'], 'description': 'insulin glargine once daily subcutaneously over 4 weeks, dose adjustment according to a treat-to-target algorithm, sitagliptin 100 mg once daily in the morning over 4 weeks, continuation of preexisting metformin', 'armGroupLabels': ['Insulin glargine + sitagliptin + metformin']}, {'name': 'insulin glargine + preexisting metformin', 'type': 'DRUG', 'otherNames': ['Lantus'], 'description': 'insulin glargine once daily subcutaneously over 4 weeks, continuation of preexisting metformin', 'armGroupLabels': ['insulin glargine + metformin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41460', 'city': 'Neuss', 'country': 'Germany', 'facility': 'Profil Institut für Stoffwechselforschung GmbH', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'overallOfficials': [{'name': 'Sabine Arnolds, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Profil Institut für Stoffwechselforschung GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Christoph Kapitza, MD', 'oldOrganization': 'Profil Institut für Stoffwechselforschung GmbH'}}}}