A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of JNJ-28431754 in Patients With Type 2 Diabetes Mellitus

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.116 enrolled

Overview

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (ie, blood levels of JNJ-28431754) and pharmacodynamics (ie, urine and blood levels of glucose) of JNJ-28431754 compared to placebo in patients with Type 2 diabetes mellitus.

This is a randomized (study drug assigned by chance), double-blind (neither physician, patient nor the sponsor knows the assigned treatment), placebo-controlled, single and multiple (14 days) ascending dose, parallel group study in 3 study centers (United States, Germany and South Korea). Five cohorts (groups) of patients with Type 2 diabetes mellitus (T2DM) will be studied. One dose level will be evaluated in each cohort. Sixteen (16) patients will be randomly assigned to receive JNJ-28431754 and four (4) patients to receive matching placebo within each cohort. The planned doses are 30, 100, 300 and 600 mg per day. Twice-daily dosing may also be evaluated in one or more of the cohorts. An additional cohort of Asian patients will also be evaluated at a dose level, which was previously tested in a prior cohort and considered to be well tolerated. Blood and urine samples will be collected from patients during the study for pharmacokinetic and pharmacodynamic assessments. The safety and tolerability of JNJ-28431754 will be monitored throughout the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

116

Conditions

Diabetes Mellitus, Type 2

Interventions

JNJ 28431754DRUG

A liquid suspension of 30 mg, 100 mg, 300 mg of JNJ-28431754 taken once (or twice) daily or 600 mg taken once daily will be administered by study personnel directly into the patient's mouth using an oral liquid dispenser for 14 days (Day 1 and Days 3 through 16).

PlaceboDRUG

A liquid suspension of placebo will be administered by study personnel directly into the patient's mouth using an oral liquid dispenser once or twice daily for 14 days (Day 1 and Days 3 through 16).

Eligibility

Sex: ALLMin age: 25 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients must have been diagnosed with Type 2 Diabetes for at least one year before screening * Patients must be taking a stable dose of oral (by mouth) anti-diabetic monotherapy or a combination of two anti-diabetic medications * Males or postmenopausal or surgically sterile women (post-menopausal is defined as no menses for at least 18 months prior to study start or no menses for 6 to 18 months) * Body mass index (weight in kg/height in m2) should be between 20 to 39.9 kg/m2 Exclusion Criteria: * History of Type 1, brittle diabetes or secondary forms of diabetes * History of repeated severe hypoglycemic episodes * History of diabetic complications including retinopathy, nephropathy, neuropathy, gastroparesis, or ketoacidosis * History of, or currently active illness including but not limited to cardiovascular disease, hematological disease, respiratory disease, hepatic or gastrointestinal disease, endocrine/metabolic disorders, neurologic or psychiatric disease, or malignant neoplasms considered by the Investigator to be clinically significant

Locations (3)

Unnamed facility

Chula Vista, California, United States

Unnamed facility

Neuss, Germany

Unnamed facility

Seoul, South Korea

Outcomes

Primary Outcomes

The number of patients with adverse events as a measure of safety and tolerability

Time frame: Up to 34 days (baseline [Day -1] through follow up [10 days following Day 22 visit])

Secondary Outcomes

Change from baseline (Day -1) for mean 24-hour plasma glucose concentration

Time frame: Day -1 through Day 16

Change from baseline 24-hour urinary glucose excretion (UGE)

Time frame: Day -1 through 16

Change from baseline mean fasting plasma glucose

Time frame: Day -1 through Day 16

Change from baseline mean morning fasting body weight

Time frame: Day -1 through 20

Renal glucose threshold

Time frame: Day -1 through Day 16

Data from ClinicalTrials.gov

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