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A Study of the Safety and Effectiveness of a R256918 in Patients With Type 2 Diabetes
This study is ongoing, but not recruiting participants.
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00672386
  Purpose

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. 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.


Condition Intervention Phase
Nutritional and Metabolic Diseases
Endocrine System Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Drug: R256918
Phase II

MedlinePlus related topics: Diabetes Endocrine Diseases Metabolic Disorders
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title: R256918 POC Study in Diabetes

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Mean change in HbA1c from baseline to week 12

Secondary Outcome Measures:
  • Changes in fasting plasma glucose, insulin and glucagon, intestinal hormone levels, insulin sensitivity and beta cell function, lipid parameters; body weight and body mass index (BMI), blood pressure, treatment satisfaction score, safety evaluations

Estimated Enrollment: 320
Study Start Date: October 2007
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 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 remain on a calorically appropriate, low fat diet 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 hypothesis is that treatment with R256918 will improve glucose-dependent insulin secretion with weight loss improving insulin sensitivity and will be well tolerated in type 2 diabetic patients.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of Type 2 Diabetes Mellitus and treated with a stable dose of metformin for at least 2 months
  • Women must be postmenopausal or surgically incapable of childbearing or if sexually active, be practicing an effective method of birth control
  • BMI between 25 and 45 kg/m2
  • HbA1c between 7% and 10%, inclusive
  • Fasting plasma glucose not exceeding 240mg/dL (13.3mmol/L)

Exclusion Criteria:

  • Diabetes other than type 2 diabetes mellitus
  • Treatment with oral anti-diabetic agents (other than metformin) or insulin during the 12 weeks before baseline visit
  • History of intolerance or hypersensitivity to sulfonylurea or sitagliptin
  • History of clinically significant gastrointestinal, hepatic or cardiovascular disease
  • Active proliferative diabetic retinopathy
  • History of diabetic gastroparesis
  • Concurrent use of systemic corticosteroid
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00672386

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Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Study ID Numbers: CR013051
Study First Received: May 2, 2008
Last Updated: October 31, 2008
ClinicalTrials.gov Identifier: NCT00672386  
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Metabolic Syndrome
Type 2 Diabetes
Adult-Onset Diabetes Mellitus
HbA1c
Body Weight
Diabetes

Study placed in the following topic categories:
Body Weight
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009