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A Multicenter, Double-Blind, Randomized, Active Controlled Study to Compare the Effect of 52 Weeks Treatment with LAF237 50 mg bid to Gliclazide up to 320 mg Daily as Add-On Therapy in Patients with Type 2 Diabetes Inadequately Controlled with Metformin Monotherapy

A Multicenter, Double-Blind, Randomized, Active Controlled Study to Compare the Effect of 52 Weeks Treatment with LAF237 50 mg bid to Gliclazide up to 320 mg Daily as Add-On Therapy in Patients with Type 2 Diabetes Inadequately Controlled with Metformin Monotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-000542-20-IT
Enrollment
Unknown
Registered
2004-09-17
Start date
2004-07-16
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

treatment of type 2 diabetes in combination therapy with other anti-diabetic oral drugs MedDRA version: 6.1 Level: HLGT Classification code 10018424

Interventions

Trade Name: IPOGLICEMIZZANTI ORALI Product Name: S-enantiomer of a 2-cyano-pyrrolidide Product Code: LAF237 Pharmaceutical Form: Tablet INN or Proposed INN: ORAL BLOOD GLUCOSE LOWERING DRUGS CAS Num

Sponsors

NOVARTIS FARMA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):—

Countries

Czech Republic, Denmark, Hungary, Italy, Spain, United Kingdom

Outcome results

None listed

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