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

NCT01177163 | Completed Phase 1

• 1 other identifier: CR014881
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacodynamic effects and pharmacokinetic characteristics of JNJ-28431754 after multiple dosing in patients with Type 2 Diabetes Mellitus who are on a stable dose of insulin.

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes mellitus; Canagliflozin; JNJ-28431754; Insulin; Pharmacokinetic; Pharmacodynamic; SGLT-1

Outcome Measures

Primary Outcomes (3)

• The proportion of patients who need to decrease insulin dosage from prestudy dosage levels because of hypoglycemia

  From time of signed informed consent (Days -52 to -32) through to the end of the study (Days 34 to 39) or at the time of early withdrawal

• The number of patients with specific treatment-emergent adverse events

  From time of signed informed consent (Days -52 to -32) through to the end of the study (Days 34 to 39) or at the time of early withdrawal

• The number of patients with symptomatic hypoglycemia and severe hypoglycemia

  From time of signed informed consent (Days -52 to -32) through to the end of the study (Days 34 to 39) or at the time of early withdrawal

Secondary Outcomes (3)

• Plasma concentrations and pharmacokinetics parameters for JNJ 28431754

  At protocol-specified timepoints from Day 1 (pre-dose) to Day 29

• Plasma glucose concentration-time profiles (pharmacodynamics parameter)

  At protocol specified timepoints on Day -1, Day 1, and Day 27

• Change in urine glucose excretion (pharmacodynamics parameter)

  At protocol specified timepoints on Day -1, Day 1, and Day 27

Study Arms (3)

001

OTHER

Placebo one placebo capsule once daily for 3 days immediately prior to randomization to double-blind treatment with JNJ 28431754 or placebo

Drug: Placebo

002

EXPERIMENTAL

JNJ 28431754 100 mg/placebo one 100-mg capsule of JNJ-28431754 or placebo once-daily for 4 weeks

Drug: JNJ 28431754 100 mg/placebo

003

EXPERIMENTAL

JNJ 28431754 300 mg/placebo one 300-mg capsule of JNJ-28431754 or placebo twice-daily for 4 weeks

Drug: JNJ 28431754 300 mg/placebo

Interventions

Placebo DRUG

one placebo capsule once daily for 3 days immediately prior to randomization to double-blind treatment with JNJ 28431754 or placebo

001

JNJ 28431754 300 mg/placebo DRUG

one 300-mg capsule of JNJ-28431754 or placebo twice-daily for 4 weeks

003

JNJ 28431754 100 mg/placebo DRUG

one 100-mg capsule of JNJ-28431754 or placebo once-daily for 4 weeks

002

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have been diagnosed with T2DM for at least 6 months prior to study screening
• Be on stable insulin regimens at the time of screening
• Have a stable weight (ie, no change more than 5% in the 3 months prior to screening)
• Have a glycosylated hemoglobin (A1C) of \>=7% and \<=10.5% at study screening

You may not qualify if:

• Have history of Type 1 diabetes mellitus, secondary forms of diabetes, diabetic ketoacidosis, pancreas or beta cell transplantation
• Have a known history of more than 2 severe hypoglycemic episodes as defined by the protocol within the past year
• Have history of, or currently active, significant illness as determined by the Investigator

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (2)

Unknown Facility

Chula Vista, California, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Related Links

• A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-28431754 in T2DM Subjects not Optimally Controlled (HbA1c: ≥7.0%) on Fixed Doses of Insulin Therapy

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: August 6, 2010
• Study Start: May 1, 2008
• Study Completion: March 1, 2009
• Last Updated: May 29, 2013

Record last verified: 2013-05

Locations

US (2)