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A 28-Week Extension to a Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 24 Weeks Treatment with LAF237 (50 mg qd or bid) to Placebo as Add-On Therapy in Patients with Type 2 Diabetes Inadequately Controlled with Metformin Monotherapy

A 28-Week Extension to a Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 24 Weeks Treatment with LAF237 (50 mg qd or bid) to Placebo as Add-On Therapy in Patients with Type 2 Diabetes Inadequately Controlled with Metformin Monotherapy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-002757-31-SE
Enrollment
38
Registered
2004-10-22
Start date
2004-12-16
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

Type 2 Dibetes

Interventions

Product Code: LAF237A Pharmaceutical Form: Tablet INN or Proposed INN: vildagliptin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the p

Sponsors

Novartis Sverige AB
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Details of inclusion and exclusion into the core study can be found in the core protocol. Inclusion criteria for Extension 1. Written informed consent to participate in the extension study. 2. Ability to comply with all study requirements. 3. Agreement to maintain the same dose of metformin as in the core study in the extension 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Premature discontinuation from the core study. 2. Concomitant medical conditions that interfere with the interpretation of study results as defined in the original protocol. 3. Failure to comply with the original study protocol. 4. Any patients that the primary investigator decides should not participate in the extension study.

Design outcomes

Primary

MeasureTime frame
Main Objective: 1. To assess the long-term safety of LAF237 in combination with metformin after 52 weeks of treatment. 2. To assess the long-term efficacy of LAF237 in combination with metformin by evaluating the effect on HbA1c after 52 weeks of treatment. ;Secondary Objective: To assess the long-term efficacy of LAF237 in combination with metformin by evaluating the effect on HbA1c and on FPG after 52 weeks of treatment as compared to the end of the core study (Week 24). To assess the mechanism of action of LAF237 in combination with metformin by evaluating the effect on beta-cell function (indexed by the fasting proinsulin concentration, fasting proinsulin/insulin ratio and HOMA B) and insulin resistance (indexed by the fasting insulin concentration and HOMA IR) after 52 weeks of treatment as compared to the baseline and compared to the end of the core study (Week 24). ;Primary end point(s):—

Countries

Sweden

Outcome results

None listed

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