Trials / Completed

CompletedNCT00672386

A Study of the Safety and Effectiveness of a R256918 in Patients With Type 2 Diabetes

A 12-Week, Double-Blind, Randomized, Placebo-Controlled Study in Type 2 Diabetes Mellitus Subjects to Evaluate the Efficacy, Safety and Tolerability of MTP Inhibitor JNJ-16269110 (R256918)

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 352 (actual)

Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
Sex: All
Age: 18 Years – 70 Years
Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the effectiveness and safety of 12 weeks of treatment with R256918 in patients with Type 2 Diabetes Mellitus who are taking metformin. The primary measure of effectiveness is the change in concentration of glycated hemoglobin (HbA1c) during treatment. Glycated hemoglobin is a substance in red blood cells that is formed when blood sugar (glucose) attaches to hemoglobin and is a measure of diabetic status. Additional measures include fasting glucose, and lipid levels, and body weight. Safety assessments performed during the trial include laboratory tests, vital sign measurements, and adverse event reporting.

Detailed description

This is a randomized (assigned study drug by chance), double-blind (both the patient and investigator do not know whether patient is assigned to receive study drug or placebo), placebo-controlled study involving patients with Type 2 Diabetes Mellitus who are taking metformin. Patients are randomized to one of 4 treatment groups and receive study drug (R256918: 5 mg, 10 mg, or 15 mg twice daily) or placebo for a period of 12 weeks. The study consists of a screening period, a baseline visit, the treatment period of 12 weeks, and a follow-up visit. During the treatment period, patients visit the center every two weeks. On each visit, patients come to the clinic after 8 hours fasting. Effectiveness assessments from a blood sample include levels of fasting hemoglobin type A1c (HbA1c), glucose, cholesterol, triglycerides, insulin, C-peptide, and gastrointestinal hormones. Patients monitor their fasting blood glucose and record it in a diary. Insulin sensitivity and beta cell (insulin-producing cells in the pancreas) function are evaluated. Waist and hip circumference are measured. Safety evaluations, including incidence of adverse events, clinical laboratory results, vital signs, and electrocardiograms, are performed during the study. Patients complete a questionnaire related to treatment satisfaction of study medication. Patients receive dietary counseling and will be instructed to remain on a calorically appropriate diet with a maximum of 30 percent (%) of calories derived from fat (in accordance with local practice guidelines for the treatment of type 2 diabetes mellitus), during the entire study. Patients continue taking metformin in the same dose and according to the same dosing regimen as before the study. The overall duration of the study for each patient is approximately 18 weeks. The study will evaluate the effect of R25691 on glucose-dependent insulin secretion, weight loss and changes in insulin sensitivity and tolerability in type 2 diabetic patients.

Conditions

Interventions

Type	Name	Description
DRUG	JNJ16269110	5 mg twice daily for 12 weeks
DRUG	JNJ16269110	10 mg twice daily for 12 weeks
DRUG	JNJ16269110	15 mg twice daily for 12 weeks
DRUG	Placebo	twice daily for 12 weeks
DRUG	Metformin	Participants will continue taking metformin at the same dose and according to the same dosing regimen as before the study.
OTHER	Dietary Counseling	Participants will receive dietary counseling at Screening, Week 4, 8, 12, and will be instructed to remain on a calorically appropriate diet with a maximum of 30% of calories derived from fat (in accordance with local practice guidelines for the treatment of type 2 diabetes mellitus) during the entire study.

Timeline

Start date: 2007-12-01
Primary completion: 2008-09-01
Completion: 2008-09-01
First posted: 2008-05-06
Last updated: 2014-07-14

Locations

62 sites across 11 countries: Belgium, Denmark, Finland, Germany, India, Netherlands, Norway, Poland, Russia, Sweden, United Kingdom

Source: ClinicalTrials.gov record NCT00672386. Inclusion in this directory is not an endorsement.