type 2 diabetes mellitus MedDRA version: 14.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
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 20
Exclusion criteria
Exclusion criteria: 1. FPG =270mg/dL (15.0 mmol/L) at Visit 1. 2. use of any of the following medications as assessed at Visit 1: a. Prior use of DPP-4 inhibitors or GLP-1 analogues. b. Prior use of insulin treatment (for =7 consecutive days) in the preceding 12 weeks. c. Prior use of sulfonylurea (for =7 consecutive days) in the preceding 12 weeks. d. Use of weight control products including weight-loss medications in the last 12 weeks. e. Use of oral (=7 consecutive days) or chronic parenteral or intra-articular corticosteroid treatment within the last 8 weeks. f. Treatment with growth hormone within the previous 6 months. g. 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. 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 (as defined by consumption of more than 24 units of alcohol per week) 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. Acute infections which may affect blood glucose control within the past 4 weeks. m. Acute conditions with the potential to alter renal function within the past 6 months, such as: •?dehydration •?severe infection •?shock •?intravascular administration of iodinated contrast agents n. Acute or chronic inflammatory bowel diseases. o. Acute or chronic diabetic gastroparesis p. Acute or chronic Thyroid diseases 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) at Visit 1, confirmed by repeat measure within 3 working days. c. Total bilirubin > 2x ULN and/or direct bilirubin > 1x 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to demonstrate that a higher proportion of subjects with T2DM and inadequate glycemic control have a preference for an oral treatment with the SPC of vildagliptin/metformin compared to an injectable treatment with liraglutide as add-on to metformin after experiencing both treatments. ;Secondary Objective: • To evaluate the subjective reason of preference for an oral or and injectable treatment after experiencing both treatments. • To evaluate individual treatment satisfaction after oral and injectable treatment by using the Treatment Satisfaction Questionnaire for Medication (TSQM-9)To evaluate tolerability of both treatments • To evaluate safety parameters of both treatments • To evaluate the efficacy with regard to FPG and HbA1c reduction of both treatments • To explore the investigators preference and rationale for the further antidiabetic treatment suggestion of the patient after experiencing both treatments. ;Primary end point(s): The primary outcome variable is the patient´s preference for one treatment. Individual patient preference will be assessed by a two-choice question regarding patient’s preference, which has to be completed by the patient and recorded in the data report form. ;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints FPG and HbA1c will be analyzed descriptively. ;Timepoint(s) of evaluation of this end point: 12 weeks and 24 weeks | — |
Countries
Germany
Contacts
Public ContactMedical Competence Center
Novartis Pharma GmbH
Outcome results
None listed