Type 2 diabetes mellitus MedDRA version: 12.1 Level: LLT Classification code 10067585 Term: Type 2 diabetes mellitus
Conditions
Interventions
Trade Name: Galvus
Product Name: Vildagliptin
Product Code: LAF237
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •age: = 70 years inclusive at Visit 1. •female or male. •patients with a confirmed diagnosis of T2DM: i/treated with a stable dose of OADs for at least 12 weeks prior to Visit 1. OADs that are allowed in this study are metformin, sulfonylurea (SU), thiazolidinediones (TZDs), a-glucosidase inhibitors or meglitinides, used either as monotherapy or in combination. ii/drug-naive patients diagnosed at least 12 weeks prior to Visit 1 (drug-naive is defined as no treatment with OADs for at least 12 weeks prior to Visit 1 and no treatment with OADs for > 3 consecutive months at any time in the past). • HbA1c of = 7% and =10.0% by central laboratory at Visit 1 and assessed by the investigator to be inadequately controlled. • body mass index (BMI) in the range of 19-45 kg/m2 inclusive at Visit 1. • agreement to maintain a stable background medication dose throughout the study, if currently receiving OADs. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • FPG =270mg/dL (15mmol/L) at Visit 1. • use of any of the following medications as assessed at Visit 1: - prior use of insulin treatment (for = 7 consecutive days) in the preceding 12 weeks. - use of DPP-4 inhibitors or GLP-1 analogues in the preceding 12 weeks. - use of weight control products including weight-loss medications in the last 12 weeks. - use of oral (=7 consecutive days) or chronic parenteral or intra-articular corticosteroid treatment within the last 8 weeks. - treatment with growth hormone within the previous 6 months. - treatment with any drug 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. • 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, transient ischemic attack, or reversible ischemic neurologic deficit within the past 6 months. - unstable angina within the past 3 months. - sustained and clinically relevant ventricular arrhythmia (patients with premature ventricular contractions if deemed not clinically significant may be enrolled). - type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes (e.g. Cushing’s syndrome or acromegaly-associated diabetes). - 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. - 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. - acute infections which may affect blood glucose control within the past 4 weeks. •any of the following significant laboratory abnormalities as assessed at Visit 1 - clinically significant elevation or reduction of thyroid stimulating hormone (TSH) outside of the normal range. - clinically significant renal dysfunction: glomerular filtration rate (GFR) 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 virus (HCV) antibody test (anti-HCV). - elevated fasting triglycerides (TGs) > 500mg/dL (5.65mmol/L). • any of the following electrocardiographic abnormalities at Visit 1 - second or third degree atrio-ventricular block without a pacemaker. - long QT syndrome or QTc > 500ms. •history of hypersensitivity to DPP-4 inhibitors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study will be declared positive if at least one of the two hypotheses is significant: 1. to evaluate the efficacy of vildagliptin as initial or add-on therapy in elderly patients with T2DM who are drug-naive or inadequately controlled with oral anti-diabetic agents (OADs) by testing the hypothesis that the HbA1c reduction with vildagliptin is superior to that of placebo after 24 weeks of treatment. 2. to evaluate the proportion of elderly patients with T2DM who are drug-naive or inadequately controlled with OADs by testing the hypothesis that the proportion of patients reaching their investigator-defined individual target HbA1c while being treated with vildagliptin is superior to that of placebo after 24 weeks of treatment ;Secondary Objective: •to evaluate the safety and tolerability of vildagliptin as initial or add-on therapy in elderly patients with T2DM who are drug-naive or inadequately controlled with OADs during 24 weeks. •to evaluate the efficacy of vildagliptin as initial or add-on therapy in elderly patients with T2DM who are drug-naive or inadequately controlled with OAD by testing the hypothesis that the FPG reduction with vildagliptin is superior to that of placebo after 24 weeks of treatment. •to assess the responder rates of vildagliptin, as compared to placebo, in elderly patients with T2DM who are drug-naive or inadequately controlled with OADs. ;Primary end point(s): • HbA1c reduction. • percentage of patients reaching individual HbA1c target at week 24 or end of study. | — |
Countries
Belgium, Bulgaria, Finland, Germany, Slovakia, Spain, United Kingdom
Outcome results
None listed