A 5-year study to compare the durability of glycemic control of a combination regimen with vildagliptin & metformin versus standard-of-care monotherapy with metformin, initiated in treatment-naive patients with type 2 diabetes mellitus
- Conditions
- Type 2 Diabetes MellitusMedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2011-003712-23-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2001
1.Written informed consent must be obtained before any assessment is performed;2.Confirmed diagnosis of T2DM by standard criteria;3.T2DM diagnosed = 24 months ago;4.HbA1c =6.5% and =7.5% at Visit 1;5.Patients who are treatment-naïve, defined in this protocol as:-Patients not having ever received any anti-diabetic medication;-Patients who, after the diagnosis of T2DM =24 months ago, have received anti-diabetic medication cumulatively for not more than 3 months, and have not received any antidiabetic treatment within 3 months prior to Visit 1;-Patients who initiated metformin within 1 month prior to Visit 1 and take a total daily dose of maximum 2000mg metformin at Visit 1; 6. Age =18 and =70 years old at Visit 1;7.Body mass index (BMI) =22 and =40 kg/m2 at Visit 1;8.Women of child-bearing potential must use effective methods of contraception during dosing of study treatment;9.Agreement to take the study medication as required by the study procedures;10.Agreement to continue current diet and exercise regime throughout the duration of the study, unless otherwise instructed by the investigator;11.Ability to comply with all study requirements and willingness to participate in a 5-year study.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1000
1.Pregnant or nursing (lactating) women;2.Use of any of the following medications as assessed at Visit 1:•Any anti-diabetic treatment within 3 months prior to visit 1 and any antidiabetic treatment for more than 3 consecutive months or adding up to a total of more than 3 months in the last 2 years;•Use of weight control products including weight-loss medications in the previous 3 months;•Chronic oral, parenteral or intra-articular corticosteroid treatment within 8 weeks prior to Visit 1;•Treatment with growth hormone within the previous 6 months;•Treatment with any drug or use of herbal medicine of known and frequent toxicity to a major organ, or that may interfere with the interpretation of the efficacy and safety data during the study;3.A history or evidence of any of the following:•Acute metabolic conditions such a ketoacidosis, lactic acidosis or hyperosmolar state (including coma) within the past 6 months;•Current diagnosis of congestive heart failure (NYHA III or IV);•Myocardial infarction within the past 6 months;•Coronary artery bypass surgery or percutaneous coronary intervention within the past 6 months;•Stroke or transient ischemic attack (TIA) within the past 6 months;•Unstable angina within the past 3 months;•Sustained and clinically relevant ventricular arrhythmia;•Active substance abuse, alcohol abuse (as defined by consumption of more than 24 alcohol units per week) and alcohol related history of disease within the past 2 years;•Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes;•Malignancy of an organ system treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases;•Hepatic disorder defined as:•acute or chronic liver disease, evidence of hepatitis, cirrhosis or portal hypertension;•history of imaging abnormalities that suggest liver disease (except hepatic steatosis), such as portal hypertension, capsule scalloping, cirrhosis;4.Any of the following significant laboratory abnormalities as assessed at Visit 1:•Clinically significant thyroid stimulating hormone (TSH) outside of the normal range;•Renal dysfunction defined as calculated creatinine clearance <60ml/min/1.73m2 via modified diet in renal disease (MDRD) formula;•Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN) at Visit 1, confirmed by repeat measure within 3 working days;•Total bilirubin > 2 x ULN and/or direct bilirubin > 1 x ULN confirmed by repeat measure within 3 working days;•Positive Hepatitis B surface antigen (HbsAg);•Positive Hepatitis C antibody test;•Elevated fasting triglycerides (TGs) >500mg/dL;•Clinically significant laboratory abnormalities which, in the opinion of the investigator,cause the patient to be considered inappropriate for inclusion in the study;5.Any of the following electrocardiogram (ECG) abnormalities at Visit 1:•Second or third degree atrio-ventricular block without a pacemaker;•Long QT syndrome or corrected QT >500ms;6.Previous or current participation in any vildagliptin clinical study;7.History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes;8.Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study. For more details see Sections 4.1 and 4.2 of the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method