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

NCT00672386 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2014-07-14

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2
  • Diabetes Mellitus
  • Endocrine System Diseases
  • Nutritional and Metabolic Diseases

Interventions

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.

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • Belgium
  • Denmark
  • Finland
  • Germany
  • India
  • Netherlands
  • Norway
  • Poland
  • Russia
  • Sweden
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00672386 on ClinicalTrials.gov