type-2 diabetes mellitus that do not reach adequate glycemic control on their current sulfonylurea monotherapy MedDRA version: 15.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Galvus
Product Name: Vildagliptin
Product Code: LAF237
Pharmaceutical Form: Tablet
INN or Proposed INN: VILDAGLIPTIN
CAS Number: 274901-16-5
Current Sponsor code: LAF237
Concentration unit
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age > 18 and =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. Patients who are taking any other anti-diabetes drug (oral or injection) other than an SU component in the preceding 12 weeks. 2. Use of any prohibited medication as per protocol section 6.6. 3. A history or evidence of any of the following: a. Acute metabolic conditions such a ketoacidosis, lactic acidosis or hyperosmolar state (including diabetic precoma or coma) within the past 6 months. b. Current diagnosis of congestive heart failure (NYHA III or IV). c. Myocardial infarction within the past 6 months. d. Coronary artery bypass surgery or percutaneous coronary intervention within the past 6 months e. Stroke, transient ischemic attack, or reversible ischemic neurologic deficit within the past 6 months. f. Unstable angina within the past 3 months. g. Sustained and clinically relevant ventricular arrhythmia (patients with premature ventricular contractions if deemed not clinically significant may be enrolled). h. Active substance abuse, alcohol abuse and history of alcohol-related diseases within the past 2 years. i. Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes (e.g. Cushing’s syndrome or acromegaly-associated diabetes). j. Malignancy of an organ system (other than localized basal cell carcinoma of the skin) treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. k. 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. l. Evidence of active pancreatitis within the 1 month prior to baseline assessment 4. Any of the following significant laboratory abnormalities as assessed at Visit 1: a. Clinically significant renal dysfunction: glomerular filtration rate (GFR) 3x upper limit of normal (ULN), confirmed by repeat measure within 3 working days. c. Total bilirubin (except patients with Gilbert`s disease) > 2x ULN, confirmed by repeat measure within 3 working days. d. Clinically significant laboratory abnormalities which, in the opinion of the investigator, cause the patient to be considered inappropriate for inclusion in the study. 5. Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study. 6. Patients who do not agree to take the study medication and do not want to follow the procedure as required by the study protocol. 7. Patients taking the SU component for longer than 5 years before Visit 1. 8. BMI 45 kg/m2 at Visit 1. 9. Donation of blood (500ml) or significant blood loss equaling to at least one unit of blood within the past 2 weeks of start of study or a blood transfusion within the past 12 weeks or planned regular transfusions during the study period. 10. Potentially unreliable, inability to comply with the study procedures or medications, and/or judged by the investigator to be unsuitable for the study. 11. Use of an investigative drug within 30 days or 5 half-lives of the drug, whichever is longer. 12. History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures 13. Study personnel or first de
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To demonstrate that add-on to glimeperide vildagliptin is superior to NPH insulin with respect to the incidence of the combined endpoint, defined as a blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic events (BG measurement < 3.9mM (71mg/dL)) and weight gain (+3%) in T2DM patients. 2. To demonstrate that add-on to glimepiride vildagliptin is superior to NPH insulin with respect to the rate of of confirmed hypoglycemic events (BG measurement < 3.9mM (71mg/dL)) in T2DM patients. ;Secondary Objective: • To evaluate the incidence of severe hypoglycemic events in patients treated with vildagliptin versus NPH insulin add-on to glimepiride. • To evaluate the incidence of symptomatic hypoglycemic events in patients treated with vildagliptin versus NPH insulin add-on to glimepiride. • To evaluate the proportion of patients treated with vildagliptin versus NPH insulin add-on to glimepiride who reach their blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic events. • To evaluate body weight changes between Visit 2 and study end in patients treated with vildagliptin versus NPH insulin add-on to glimepiride. • To evaluate the change in HbA1c, between Visit 2 and study end in patients treated with vildagliptin versus NPH insulin add-on to glimepiride. • To evaluate treatment satisfaction between Visit 2 and study end in patients treated with vildagliptin versus NPH insulin add-on to glimepiride by using the TSQM-9 questionnaire. ;Primary end point(s): 1. To demonstrate that add-on to glimeperide vildagliptin is superior to NPH insulin with respect to the incidence of the combined endpoint, defined as a blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic events (BG measurement < 3.9mM (71mg/dL)) and weight gain (+3%) in T2DM patients. 2. To demonstrate that add-on to glimepiride vildagliptin is superior to NPH insulin with respect to the rate of of confirmed hypoglycemic events (BG meas | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To evaluate the incidence of severe hypoglycemic events in patients treated with vildagliptin versus NPH insulin add-on to glimepiride. • To evaluate the incidence of symptomatic hypoglycemic events in patients treated with vildagliptin versus NPH insulin add-on to glimepiride. • To evaluate the proportion of patients treated with vildagliptin versus NPH insulin add-on to glimepiride who reach their blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic events. • To evaluate body weight changes between Visit 2 and study end in patients treated with vildagliptin versus NPH insulin add-on to glimepiride. • To evaluate the change in HbA1c, between Visit 2 and study end in patients treated with vildagliptin versus NPH insulin add-on to glimepiride. • To evaluate treatment satisfaction between Visit 2 and study end in patients treated with vildagliptin versus NPH insulin add-on to glimepiride by using the TSQM-9 questionnaire. ;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Countries
Germany
Contacts
Public ContactMedizinischer Infoservice
Novartis Pharma GmbH
Outcome results
None listed