A Study of the Safety and Effectiveness of a R256918 in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2; Diabetes Mellitus; Endocrine System Diseases; Nutritional and Metabolic Diseases
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Diseases; Endocrine System Diseases
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): JNJ16269110; JNJ16269110; JNJ16269110; Placebo; Metformin; Dietary Counseling
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Other
Intervention description(s): 5 mg twice daily for 12 weeks; 10 mg twice daily for 12 weeks; 15 mg twice daily for 12 weeks; twice daily for 12 weeks; Participants will continue taking metformin at the same dose and according to the same dosing regimen as before the study.; 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.
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes; Type 2 Diabetes; Adult-Onset Diabetes Mellitus; Metabolic Syndrome; HbA1c; Body Weight; Metformin