A multi-center, randomized, double-blind study to evaluate the efficacy and long-term safety of vildagliptin modified release (MR) as monotherapy in patients with type 2 diabetes

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-004412-12-SK

Enrollment

450

Registered

2008-10-16

Start date

2009-02-27

Completion date

Unknown

Last updated

2013-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type II Diabetes

Interventions

Product Name: vildagliptin MR Product Code: LAF237B Pharmaceutical Form: Tablet INN or Proposed INN: vildagliptin Current Sponsor code: LAF237B Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Male, non-fertile female or female of childbearing potential using a medically approved birth control method •Patients at least 18 years of age at visit 1 •Drug naïve patients with T2DM diagnosed at least 2 months prior to visit 1 •HbA1c of = 7.0 and = 10.0% 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

Exclusion criteria: •Pregnant or nursing (lactating) women •FPG = 270 mg/dL (= 15.0 mmol/L) •Any of the following significant laboratory abnormalities: - Clinically significant TSH outside of normal range at visit 1 - Serum creatinine levels > 2.5 mg/dL (220 µmol/L) at visit 1. - 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 For detailed list of the exclusion criteria, please refer to the full protocol.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1.To demonstrate the efficacy of vildagliptin MR (25 mg qd or 50 mg qd) as monotherapy in patients with T2DM by testing the hypothesis that the HbA1c reduction with vildagliptin MR is superior to that of placebo after 24 weeks of treatment. ;Secondary Objective: 1.To demonstrate the efficacy of vildagliptin MR (25 mg qd or 50 mg qd) as monotherapy in patients with T2DM by testing the hypothesis that the FPG reduction with vildagliptin MR is superior to that of placebo after 24 weeks of treatment. 2.To evaluate the safety and tolerability of vildagliptin MR (25 mg qd or 50 mg qd) compared to placebo over 24 weeks of treatment as monotherapy in patients with T2DM. 3.To evaluate the long-term safety and tolerability of vildagliptin MR over the entire study duration as monotherapy in patients with T2DM. For detailed list please refer to the protocol ;Primary end point(s): The primary efficacy variable is change from baseline in HbA1c at Week 24 endpoint.	—

Measure

Time frame

Main Objective: 1.To demonstrate the efficacy of vildagliptin MR (25 mg qd or 50 mg qd) as monotherapy in patients with T2DM by testing the hypothesis that the HbA1c reduction with vildagliptin MR is superior to that of placebo after 24 weeks of treatment. ;Secondary Objective: 1.To demonstrate the efficacy of vildagliptin MR (25 mg qd or 50 mg qd) as monotherapy in patients with T2DM by testing the hypothesis that the FPG reduction with vildagliptin MR is superior to that of placebo after 24 weeks of treatment. 2.To evaluate the safety and tolerability of vildagliptin MR (25 mg qd or 50 mg qd) compared to placebo over 24 weeks of treatment as monotherapy in patients with T2DM. 3.To evaluate the long-term safety and tolerability of vildagliptin MR over the entire study duration as monotherapy in patients with T2DM. For detailed list please refer to the protocol ;Primary end point(s): The primary efficacy variable is change from baseline in HbA1c at Week 24 endpoint.

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Countries

Slovakia

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026