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Register:	EUCTR
Last refreshed on:	24 July 2012
Main ID:	EUCTR2008-004722-16-IT
Date of registration:	17/11/2008
Prospective Registration:	Yes
Primary sponsor:	NOVARTIS FARMA
Public title:
Scientific title:	A multi-center, randomized, double-blind study to evaluate the efficacy and long-term safety of vildagliptin modified release (MR) as add-on therapy to metformin in patients with type 2 diabetes - ND
Date of first enrolment:	18/11/2008
Target sample size:	2400
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-004722-16
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: triple-dummy If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: yes Other specify the comparator: - same IMP used at different dosage
Phase:

Countries of recruitment
Austria	Belgium	Denmark	Estonia	Finland	Germany	Greece	Hungary
Italy	Latvia	Lithuania	Sweden	United Kingdom

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
Patients eligible for inclusion in this study have to fulfill all of the following criteria: 1. Age in the range of 18-78 years inclusive at visit 1. 2. Patients with T2DM treated with metformin for at least 3 months and a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1. 3. Agreement to maintain the same dose of metformin throughout the study. 4. HbA1c of ≥ 7.0 and ≤ 9.5% at visit 1. 5. Body Mass Index (BMI) in the range of 22-45 kg/m2 at visit 1. 6. Male, non-fertile female or female of childbearing potential using a medically approved birth control method based on local regulations: A non-fertile female is defined as: post menopausal (12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml); 6 weeks post bilateral oophorectomy with or without hysterectomy; post hysterectomy; or sterilized by tubal ligation. A female of childbearing potential is defined as any woman physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means. Medically approved birth control method may include: hormonal contraceptives, IUD, and double-barrier contraception (if accepted by local regulatory authority and ethics committee). Acceptable methods of contraception may include total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the subject ensures compliance. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study. 7. Agreement to continue their current diet/exercise regimen throughout the duration of the study unless otherwise instructed by the trial?s physician. 8. Patients must give written informed consent before any assessment is performed.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Pregnant or nursing (lactating) women, where pregnancy is 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). 2. FPG ≥ 270 mg/dL (≥ 15.0 mmol/L). 3. Any of the following significant laboratory abnormalities: Clinically significant TSH outside of normal range at visit 1 Clinically significant renal dysfunction as indicated by serum creatinine levels ≥ 1.5 mg/dL (132 μmol/L) for males and ≥ 1.4 mg/dL (123 μmol/L) for females at visit 1, or a history of abnormal creatinine clearance Elevated fasting triglycerides > 500 mg/dL at visit 1, confirmed by a repeat measure within 3 working days Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 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 > ULN at visit 1, confirmed by repeat measure within 3 working days Positive Hepatitis B surface antigen (HbsAg) Positive Hepatitis C antibody test (anti-HCV) Clinically significant laboratory abnormalities at the opinion of the investigator 4. Congestive heart failure requiring pharmacological treatment. 5. A history of: type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. Cushing?s syndrome and acromegaly. acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months. Liver disease, such as cirrhosis, or chronic active hepatitis B or C. active substance abuse (including alcohol and alcohol related hepatic disease) within the past 2 years. hypersensitivity to any of the study drugs or to drugs of similar chemical classes. malignancy of any 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. 6. Patients taking vildagliptin, other DPP-4 inhibitors, GLP-1 mimetics (e.g. exenatide), GLP-1 analogues (e.g. liraglutide) within 6 months prior to visit 1 whether in a clinical trial or as marketed product. 7. Acute infections which may affect blood glucose control within 4 weeks prior to visit 1. PLS SEE PROTOC.

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

Health Condition(s) or Problem(s) studied

type 2 Diabetes
MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus

Intervention(s)

Product Name: vildagliptin MR
Product Code: LAF237B
Pharmaceutical Form: Tablet
INN or Proposed INN: vildagliptin MR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: vildagliptin MR
Product Code: LAF237B
Pharmaceutical Form: Tablet
INN or Proposed INN: vildagliptin MR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: JANUVIA
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: SITAGLIPTIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To demonstrate the efficacy of vildagliptin MR (12.5 mg bid or 25 mg bid) as add-on therapy to metformin in patients with T2DM by testing the hypothesis that the HbA1c reduction with vildagliptin MR added to metformin is superior to that of placebo added to metformin after 24 weeks of treatment.

Secondary Objective: To demonstrate the efficacy of vildagliptin MR (12.5 mg bid or 25 mg bid) as add-on therapy to metformin in patients with T2DM by testing the hypothesis that the HbA1c reduction with vildagliptin MR added to metformin is at least not inferior to that of sitagliptin 50 mg bid added to metformin after 24 weeks of treatment. To demonstrate the efficacy of vildagliptin MR (12.5 mg bid or 25 mg bid) as add-on therapy to metformin in patients with T2DM by testing the hypothesis that the FPG reduction with vildagliptin MR added to metformin is superior to that of placebo added to metformin after 24 weeks of treatment. To demonstrate the efficacy of vildagliptin MR (12.5 mg bid or 25 mg bid) as add-on therapy to metformin in patients with T2DM by testing the hypothesis that the FPG reduction with vildagliptin MR added to metformin is at least not inferior to that of sitagliptin 50 mg bid added to metformin after 24 weeks of treatment. PLS SEE PROTOC.

Primary end point(s): The primary hypotheses tested are the superiority of vildagliptin MR (12.5 mg bid or 25 mg bid) added to metformin over placebo added to metformin for the effect of reducing HbA1c after 24 weeks of treatment.

Secondary Outcome(s)

Secondary ID(s)

2008-004722-16-HU

CLAF237B2224

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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