Effect of Adding Vildagliptin on Beta Cell Function and Cardiovascular Risk Markers in Patients With Moderate Metabolic Control During Metformin Monotherapy
Overview[ - collapse ][ - ]
Purpose | The aim of this pilot-study is to investigate the effect of Vildagliptin in comparison to glimepiride on beta cell function and the cardiovascular risk profile in patients previously treated with Metformin monotherapy. |
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Condition | Diabetes Mellitus Type II |
Intervention | Drug: Metformin Drug: Metformin Drug: Vildagliptin Drug: Glimepiride |
Phase | Phase 4 |
Sponsor | ikfe-CRO GmbH |
Responsible Party | ikfe-CRO GmbH |
ClinicalTrials.gov Identifier | NCT01565096 |
First Received | March 23, 2012 |
Last Updated | March 26, 2012 |
Last verified | March 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | March 23, 2012 |
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Last Updated Date | March 26, 2012 |
Start Date | November 2011 |
Estimated Primary Completion Date | Not Provided |
Current Primary Outcome Measures | Postprandial increase in intact proinsulin levels in patient treated with Vildagliptin and Metformin compared to intact proinsulin levels in patients treated with Glimepiride and Metformin (Area under the curve 0-300 min) [Time Frame: One year] [Designated as safety issue: Yes] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Effect of Adding Vildagliptin on Beta Cell Function and Cardiovascular Risk Markers in Patients With Moderate Metabolic Control During Metformin Monotherapy |
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Official Title | Effect of Adding Vildagliptin on Beta Cell Function and Cardiovascular Risk Markers in Patients With Moderate Metabolic Control During Metformin Monotherapy |
Brief Summary | The aim of this pilot-study is to investigate the effect of Vildagliptin in comparison to glimepiride on beta cell function and the cardiovascular risk profile in patients previously treated with Metformin monotherapy. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Diabetes Mellitus Type II |
Intervention | Drug: Metformin Metformin 1000 mg BID Drug: Metformin Metformin 1000 mg BID Drug: Vildagliptin Vildagliptin 50 mg twice daily Drug: Glimepiride Glimepiride at individual dose |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 44 |
Estimated Completion Date | Not Provided |
Estimated Primary Completion Date | November 2012 |
Eligibility Criteria | Inclusion Criteria: - Diabetes mellitus type 2 - HbA1c > 6.5%* ≤ 9.5% * NOTE: Patients with cardiovascular preconditions (Coronary Heart Disease or Myocard Infarction) require an HbA1c > 7.0% ≤ 9.5% - Treatment with Metformin at maximal or maximal tolerated dosage, stable for at least 3 months with indication for treatment with an additional medication as judged by the investigator - Age 30 - 80 years - Patient consents that his/her family physician will be informed of trial participation Exclusion Criteria: - Pre-treatment with insulin, peroxisome proliferator activated receptor (PPAR) gamma agonists or other oral antidiabetic treatments (except Metformin) within the last three months - History of type-1-diabetes - Fasting blood glucose >240mg/dl - Uncontrolled hypertension (systolic blood pressure >160 and/or diastolic blood pressure >90) - Anamnestic history of acute infections - Anamnestic history of epilepsy - Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures - History of severe or multiple allergies - Hereditary galactose intolerance, lapp-lactase defect or glucose-galactose mal-absorption - Treatment with any other investigational drug within 3 months before trial entry - Pregnant or lactating women - Sexually active woman of childbearing age not practicing a highly effective method of birth control as defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices, sexual abstinence or vasectomized partner - Progressive fatal disease - History of drug or alcohol abuse in the past 2 years - State after kidney transplantation - Serum potassium > 5.5 mmol/L - Acute myocardial infarction, open heart surgery or cerebral event (stroke/transient ischemic attack) within the previous 6 months - Any elective surgery during study participation - Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to screening visit - History of pancreatitis - Anamnestic history of dehydration, diabetic precoma or diabetic ketoacidosis - Acute or scheduled investigation with iodine containing radiopaque material - Uncontrolled unstable angina pectoris - Anamnestic history of pericarditis, myocarditis, endocarditis, hemodynamic relevant aortic stenosis, aortic aneurysm or heart insufficiency NYHA III or IV - Anamnestic recent pulmonary embolism - History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (GFR < 60 ml), neurological, psychiatric and/or hematological disease as judged by the investigator - Lack of compliance or other similar reason that, according to investigator, precludes satisfactory participation in the study |
Gender | Both |
Ages | 30 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Thomas Forst, Prof. Dr. +49 6131 576 36 16 thomasf@ikfe.de |
Location Countries | Germany |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01565096 |
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Other Study ID Numbers | ikfe-Vilda-001 |
Has Data Monitoring Committee | No |
Information Provided By | ikfe-CRO GmbH |
Study Sponsor | ikfe-CRO GmbH |
Collaborators | Novartis Pharmaceuticals IKFE Institute for Clinical Research and Development |
Investigators | Principal Investigator: Thomas Forst, Prof. Dr. Ikfe GmbH |
Verification Date | March 2012 |
Locations[ + expand ][ + ]
ikfe GmbH | Mainz, Germany, 55116 Contact: Thomas Forst, Prof., MD | +49 6131 576 36 16 | thomasf@ikfe.deRecruiting |
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