Patient preferences for Eucreas® versus Victoza® in Type 2 Diabetes mellitus patients

• Register: EUCTR
• Last refreshed on: 7 October 2014
• Main ID: EUCTR2011-003818-16-DE
• Date of registration: 12/10/2011
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma GmbH
• Public title: Patient preferences for Eucreas® versus Victoza® in Type 2 Diabetes mellitus patients
• Scientific title: A randomized, open-label, cross-over study to evaluate patient preferences for Eucreas® versus Victoza® as add-on to Metformin in Type 2 Diabetes mellitus patients who did not have adequate glycaemic control with metformin
• Date of first enrolment: 21/12/2011
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-003818-16
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Germany

Contacts

• Name: Medical Competence Center
• Affiliation: Novartis Pharma GmbH

• Name: Medical Competence Center
• Affiliation: Novartis Pharma GmbH

Key inclusion & exclusion criteria

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

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

Intervention(s)

Trade Name: Eucreas
Product Name: Eucreas
Product Code: LMF237
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: VILDAGLIPTIN
CAS Number: 274901-16-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: METFORMIN HYDROCHLORIDE
CAS Number: 1115-70-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-

Trade Name: Victoza
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: LIRAGLUTIDE
CAS Number: 204656-20-2
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6-

Trade Name: Metformin Stada
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: METFORMIN HYDROCHLORIDE
CAS Number: 1115-70-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-

Primary Outcome(s)

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.

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.

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.

Timepoint(s) of evaluation of this end point: 24 weeks

Secondary Outcome(s)

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

Secondary ID(s)

CLMF237ADE03

Source(s) of Monetary Support

Novartis Pharma GmbH