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Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00642278 |
The purpose of this study is to evaluate the effectiveness, safety, and tolerability of JNJ-28431754 compared with placebo in patients with type 2 diabetes.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Non Insulin Dependent Diabetes Mellitus, Type II |
Drug: JNJ-28431754 Drug: sitagliptin Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Double-Dummy, Parallel Group, Multicenter, Dose-Ranging Study in Subjects With Type 2 Diabetes Mellitus to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered SGLT2 Inhibitor JNJ-28431754 With Sitagliptin as a Reference Arm. |
Enrollment: | 451 |
Study Start Date: | February 2008 |
Study Completion Date: | January 2009 |
Arms | Assigned Interventions |
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001: Experimental |
Drug: JNJ-28431754
50 mg qd
|
002: Experimental |
Drug: JNJ-28431754
100 mg qd
|
003: Experimental |
Drug: JNJ-28431754
200 mg qd
|
004: Experimental |
Drug: JNJ-28431754
300mg qd
|
005: Experimental |
Drug: JNJ-28431754
300 mg bid
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006: Active Comparator |
Drug: sitagliptin
100 mg qd
|
007: Placebo Comparator |
Drug: placebo
placebo
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Type 2 diabetes mellitus is a metabolic disorder that is characterized by decreased secretion of insulin by the pancreas and resistance to the action of insulin in various tissues (muscle, liver, and adipose), which results in impaired glucose uptake. Chronic hyperglycemia leads to progressive impairment of insulin secretion and to insulin resistance of peripheral tissues in diabetes (so-called glucose toxicity), which further worsens control of blood glucose. In addition, chronic hyperglycemia is a major risk factor for complications, including heart disease, retinopathy, nephropathy, and neuropathy.
Although numerous treatments have been developed for the treatment of diabetes and individual agents may be highly effective for some patients, it is still difficult to maintain optimal glycemic control in most patients with diabetes. This is a randomized, double-blind placebo-controlled, parallel group, multicenter, dose-ranging study to determine the efficacy, safety and tolerability of JNJ-28431754 taken orally over 12 weeks, compared with placebo, in the treatment of Type 2 diabetes mellitus. The primary clinical hypothesis is that JNJ-28431754 is superior to placebo as measured by the change in hemoglobin A1c from baseline through Week 12 in the treatment of type 2 diabetes mellitus. Subject safety will be monitored throughout the study using spontaneous adverse event reporting, clinical laboratory tests (hematology, serum chemistry, urinalysis); severe and serious hypoglycemic episodes, assessment of urinary albumin excretion and markers of proximal renal tubular function; pregnancy tests; electrocardiograms (ECGs); vital sign measurements; physical examinations, assessment of calcium and phosphate homeostasis, bone formation and resorption markers, and hormones regulating calcium and phosphorus homeostasis; and vaginal and urine sample collection for fungal and bacterial culture in subjects with symptoms consistent with vulvovaginal candidiasis (VVC) or urinary tract infection (UTI).
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Responsible Party: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. ( Vice President ) |
Study ID Numbers: | CR014587 |
Study First Received: | March 21, 2008 |
Last Updated: | March 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00642278 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Hemoglobin A1c Metformin Type 2 diabetes mellitus |
Dipeptidyl-Peptidase IV Inhibitors Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Protease Inhibitors Sitagliptin |
Dipeptidyl-Peptidase IV Inhibitors Metabolic Diseases Molecular Mechanisms of Pharmacological Action Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Enzyme Inhibitors Glucose Metabolism Disorders Pharmacologic Actions Protease Inhibitors Sitagliptin |