This study is to check the efficacy, safety, and tolerability of JNJ-28431754 compared with glimepiride in patients with type 2 diabetes

A Randomized, Double-Blind, 3-Arm Parallel-Group, 2-Year (104-Week), Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-28431754 Compared With Glimepiride in the Treatment of Subjects With Type 2 Diabetes Mellitus Not Optimally Controlled on Metformin Monotherapy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000595

Enrollment

1281

Registered

2010-06-18

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Type 2 diabetes mellitus (T2DM)

Interventions

Intervention1: JNJ-28431754 100 or 300 mg orally: 100 or 300 mg once daily orally for 104 weeks Control Intervention1: Glimepiride (oral): starting oral dosage of 1mg increased to max of 6 or 8 mg on

Eligibility

Inclusion criteria

Inclusion criteria: Patients must have a diagnosis of type 2 diabetes Body mass index (BMI) more than or equal to 22 to less than or equal to 45 kg per sqm at screening Patients must be taking a stable dosage of metformin as monotherapy at screening Patients must have a HbA1c between more than or equal to 7percent and less than or equal to 9.5percent at Week 2 Patients must have a fasting plasma glucose (FPG) less than or equal to 270 mgperdL ie 15 mmolperL at Week -2

Exclusion criteria

Exclusion criteria: Patients having prior exposure or known contraindication or suspected hypersensitivity to JNJ-28431754, glimepiride, or metformin History of diabetic ketoacidosis or type 1 diabetes mellitus History of pancreas or beta-cell transplantation History of active proliferative diabetic retinopathy History of hereditary glucose-galactose malabsorption or primary renal glucosuria Renal disease requiring treatment with immunosuppressive therapy within the past 12 months before screening or a history of dialysis or renal transplant Taken thiazolidinedione therapy in the past 16 weeks before screening

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoint is the change in Hemoglobin A1cTimepoint: From baseline through Week 52	—

Secondary

Measure	Time frame
The percent change in body weightTimepoint: From baseline through Week 52	—

Countries

Argentina, Bulgaria, Canada, Costa Rica, Denmark, Finland, Germany, India, Israel, Mexico, Norway, Philippines, Poland, Romania, Russian Federation, Slovakia, Ukraine, United States of America

Contacts

Public ContactDr Jitendra Dixit

Global Clinical Operations India

jdixit@its.jnj.com02266646464

Outcome results

None listed

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