A 28-week extension to a multicenter, randomized, double-blind, active controlled study to compare the effect of 24 weeks treatment with LAF237 50 mg bid to rosiglitazone 8 mg qd in drug naïve patients with type 2 diabetes Extensión de 28 semanas del estudio multicéntrico, aleatorizado, doble ciego, con control activo que compara el efecto de 24 semanas de tratamiento con 50 mg bid de LAF237 frente a 8 mg qd de rosiglitazona en pacientes naive con diabetes Tipo 2.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002644-10-ES

Enrollment

660

Registered

2004-12-07

Start date

2005-01-19

Completion date

Unknown

Last updated

2015-02-02

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

Conditions

Diabetes Mellitus II

Interventions

Product Name: LAF237 Product Code: LAF237 Pharmaceutical Form: Tablet INN or Proposed INN: LAF237 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Written informed consent to participate in the extension study. Ability to comply with all study requirements. Details of inclusion and exclusion into the core study can be found in the core protocol 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: Premature discontinuation from the core study. Concomitant medical conditions that interfere with the interpretation of study results as defined in the core protocol. Failure to comply with the core study protocol. Any patients that the primary investigator decides should not participate in the extension study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the long-term safety of LAF237 compared to rosiglitazone during 52 weeks of treatment. To assess the long-term efficacy of LAF237 compared to rosiglitazone by evaluating the effect on HbA1c after 52 weeks of treatment as compared to the baseline. ;Secondary Objective: To assess the long-term efficacy of LAF237 compared to rosiglitazone by evaluating the effect on HbA1c after 52 weeks of treatment To assess the long-term efficacy of LAF237 compared to rosiglitazone by evaluating the effect on FPG after 52 weeks of treatment To assess the mechanism of action of LAF237 compared to rosiglitazone by evaluating the effect on beta-cell function and insulin resistance after 52 weeks of treatment To assess the ancillary clinical benefits of LAF237 compared to rosiglitazone by evaluating the effect on fasting plasma lipid profiles and body weight after 52 weeks of treatment To assess the ancillary benefits of LAF237 compared to rosiglitazone by evaluating the effect on quality of life, patient satisfaction, and work productivity after 52 weeks of treatment. ;Primary end point(s): HbA1c	—

Measure

Time frame

Main Objective: To assess the long-term safety of LAF237 compared to rosiglitazone during 52 weeks of treatment. To assess the long-term efficacy of LAF237 compared to rosiglitazone by evaluating the effect on HbA1c after 52 weeks of treatment as compared to the baseline. ;Secondary Objective: To assess the long-term efficacy of LAF237 compared to rosiglitazone by evaluating the effect on HbA1c after 52 weeks of treatment To assess the long-term efficacy of LAF237 compared to rosiglitazone by evaluating the effect on FPG after 52 weeks of treatment To assess the mechanism of action of LAF237 compared to rosiglitazone by evaluating the effect on beta-cell function and insulin resistance after 52 weeks of treatment To assess the ancillary clinical benefits of LAF237 compared to rosiglitazone by evaluating the effect on fasting plasma lipid profiles and body weight after 52 weeks of treatment To assess the ancillary benefits of LAF237 compared to rosiglitazone by evaluating the effect on quality of life, patient satisfaction, and work productivity after 52 weeks of treatment. ;Primary end point(s): HbA1c

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Countries

Spain

Outcome results

None listed

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