| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| E.1.1.1 | Medical condition in easily understood language |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10045242 |
| E.1.2 | Term | Type II diabetes mellitus |
| E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| 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. |
|
| E.2.2 | Secondary objectives of the trial |
• 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.
|
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Age: > 18 and < 80 years at Visit 1.
2. Patients with a confirmed diagnosis of T2DM:
3. Patients treated with a stable dose of 1000mg Metformin bid for at least 12 weeks prior to Randomization (Visit 2)
4. Patients with a medical indication, as assessed by the investigator, which requires the expansion of the current anti diabetic therapy
5. HbA1c of ≥ 6.5% and ≤ 9.0% by central laboratory at Visit 1 and assessed by the investigator to be inadequately controlled.
6. Body mass index (BMI) in the range of 19-35kg/m2 inclusive at Visit 1.
7. Agreement to maintain their current diet and exercise habits during the full course of the study.
8. Signed informed consent to participate in the study.
|
|
| E.4 | Principal 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) <60mL/min/1.73m2 (via modification of diet in renal disease (MDRD) formula).
b. alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 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.
5. Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
6. Donation of blood 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.
7. Potentially unreliable, inability to comply with the study procedures or medications, and/or judged by the investigator to be unsuitable for the study.
8. Use of an investigative drug within 30 days or 5 half-lives of the drug, whichever is longer.
9. History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
10. Study personnel or first degree relatives of investigator(s) must not be included in the study.
11. Women
o who are pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml))
o who are menstruating and capable of becoming pregnant* and not practicing a medically approved method of contraception (Pearl Index <1**) during and up to at least 4 weeks after the end of treatment. A negative pregnancy test (serum) for all women and for girls entering menarche is required with sufficient lead time before inclusion
|
|
| E.5 End points |
| E.5.1 | 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. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | Secondary end point(s) |
| The secondary endpoints FPG and HbA1c will be analyzed descriptively. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | Yes |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | Yes |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 11 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | 0 |
Print
