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

• Register: EUCTR
• Last refreshed on: 10 December 2012
• Main ID: EUCTR2008-004722-16-DE
• Date of registration: 25/11/2008
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public 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
• 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
• Date of first enrolment: 26/01/2009
• Target sample size: 2500
• 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: no

Countries of recruitment

Austria, Belgium, Denmark, Estonia, Finland, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
• Male, non-fertile female or female of childbearing potential using a medically approved birth control method
• Age in the range of 18-78 years inclusive at visit 1.
• 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.
• Agreement to maintain the same dose of metformin throughout the study.
• HbA1c of = 7.0 and = 9.5% at visit 1.
• Body Mass Index (BMI) in the range of 22-45 kg/m2 at visit 1.

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.

For detailed exclusion criteria, please refer to the full protocol.


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

Health Condition(s) or Problem(s) studied

Type 2 Diabetes

Intervention(s)

Product Name: Vildagliptin MR
Product Code: LAF237
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Vildagliptin
CAS Number: 274901-16-5
Current Sponsor code: LAF237
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: LAF237
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Vildagliptin
CAS Number: 274901-16-5
Current Sponsor code: LAF237
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
Product Name: Sitagliptin
Pharmaceutical Form: Tablet
INN or Proposed INN: Sitagliptin
CAS Number: 486460-32-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): The primary efficacy variable is change from baseline in HbA1c at Week 24 endpoint.

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 evaluate the safety and tolerability of vildagliptin MR (12.5 mg bid or 25 mg bid) compared to placebo and sitagliptin over 24 weeks of treatment as add-on therapy to metformin in patients with T2DM.

For detailed secondary objectives, please refer to the full protocol.

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 ID(s)

CLAF237B2224

2008-004722-16-HU