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To Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Single and 14-Day Multiple Oral (by Mouth) Doses of JNJ-28431754 in Patients With T2DM

2014-08-27 03:19:51 | BioPortfolio

Summary

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

Description

This was 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 (US, Germany and South Korea). Five cohorts of patients with Type 2 diabetes mellitus (T2DM) were studied. One dose level was evaluated in each cohort. Sixteen (16) patients were randomized to JNJ-28431754 and four (4) to matching placebo within each cohort. Doses studied were 30, 100, 200 and 400 mg once daily and 300 mg twice daily. An additional cohort of Asian patients was also evaluated at the 30 mg dose level. Following initial screening, eligible patients were instructed to discontinue their previous anti-diabetic medications for 16 days prior to dosing on Day 1. Blood glucose levels were monitored daily during the 16-day washout period to ensure their blood glucose levels remained within a well-tolerated range. Eligible patients were admitted to the Clinical Research Unit (CRU) three days prior to starting study medication. On the 2 days prior to randomization, all patients received placebo once daily in a single-blind fashion (patients blinded) and underwent baseline safety and pharmacodynamic (PD) assessments. Eligible patients were then randomized to a double-blind treatment with JNJ-28431754 or placebo. A single dose of study medication was administered on Day 1, followed by periodic safety, Pharmacokinetic (PK) and PD assessments for 48 hours. Daily dosing resumed on Day 3 and continued through Day 16. Each daily dose was administered at approximately the same time each day (between 8 AM and 9 AM) followed by a standardized breakfast within 10 minutes after dosing. Standardized lunch and dinner were provided at 4.5 and 10.5 hours post dose, respectively. For a twice daily dosing regimen, the evening dose was administered approximately 10 minutes prior to the standardized dinner. The standardized meals used in this study were in accordance with recommendations of the American Diabetes Association. Patients were discharged from the CRU on Day 20 (96 hours after last dosing on Day 16) and returned to the CRU for safety assessments and blood sample collections for PK on the mornings of Days 21 to 22. Patients also returned within 7-10 days following the Day 22 outpatient visit for a final safety follow-up visit. Patients resumed their pre-study oral anti-diabetic medication regimen upon completion of the outpatient visit on Day 22 or at any earlier time during the study if their confirmed fasting blood glucose levels rose above 15 mM (270 mg/dL) [13.3 mM (240 mg/dL) for the study center in Germany) or postprandial glucose levels (blood glucose measurements after you eat a meal) rose above 22.2 mM (400 mg/dL) [19.4 mM (350 mg/dL) for the study center in Germany) following the lunch. Patients who were in need of restarting anti-diabetic medications during the study stopped receiving study medication, but continued with study related safety and PK assessments for at least 3 days after their final dose. JNJ-28431754 or placebo at 30, 100, 200, and 400 mg once daily, and 300 mg twice a day on Day 1 (No dosing on Day 2), Days 3 to 16. Dosing will be administered orally (by mouth).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Diabetes Mellitus, Type 2

Intervention

JNJ 28431754; Canagliflozin; TA-7284; Placebo

Status

Completed

Source

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

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:51-0400

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Medical and Biotech [MESH] Definitions

A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.

The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).

A subtype of DIABETES MELLITUS that is characterized by INSULIN deficiency. It is manifested by the sudden onset of severe HYPERGLYCEMIA, rapid progression to DIABETIC KETOACIDOSIS, and DEATH unless treated with insulin. The disease may occur at any age, but is most common in childhood or adolescence.

A type of diabetes mellitus that is characterized by severe INSULIN RESISTANCE and LIPODYSTROPHY. The latter may be generalized, partial, acquired, or congenital (LIPODYSTROPHY, CONGENITAL GENERALIZED).

A life-threatening complication of diabetes mellitus, primarily of TYPE 1 DIABETES MELLITUS with severe INSULIN deficiency and extreme HYPERGLYCEMIA. It is characterized by excessive LIPOLYSIS, oxidation of FATTY ACIDS, production of KETONE BODIES, a sweet smell to the breath (KETOSIS;) DEHYDRATION; and depressed consciousness leading to COMA.

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