A Study of Multiple Oral Doses of JNJ-41443532 in Patients With Type 2 Diabetes Mellitus

NCT01230749 | Completed Phase 2 Results

• 2 other identifiers: CR01740141443532EDI2001
• Study Type: interventional
• Target: 89
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (what the body does to the medication) and pharmacodynamics (what the medication does to the body) of treatment with JNJ-41443532 relative to treatment with placebo in type 2 diabetes mellitus participants.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2; Diabetes Mellitus; Hyperglycemia; JNJ-41443532; Pioglitazone; Placebo

Outcome Measures

Primary Outcomes (1)

• Change From Baseline (Day -1) to Day 28 in Twenty-Four-Hour Weighted Average Glucose (24-Hour WAG)

  Difference is calculated as the change in 24-hour WAG in Least Square Mean (LSM) from baseline to Day 28 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change. 24-hour WAG is defined as the area under the plasma glucose concentration time curve over 0 to 24 hours, divided by 24.

  From baseline (Day -1) to Day 28

Secondary Outcomes (7)

• Change From Baseline to Day 28 in Fasting Plasma Glucose (FPG)

  From baseline to Day 28

• Change From Baseline to Day 28 in Insulin Secretion

  From baseline to Day 28

• Change From Baseline to Day 28 in Insulin Resistance

  From baseline to Day 28

• Change From Baseline to Day 28 in Systemic Levels of Interleukin 6 (IL-6)

  From baseline to Day 28

• Change From Baseline to Day 28 in Systemic Levels of Interleukin 18 (IL-18)

  From baseline to Day 28

Study Arms (4)

JNJ-41443532 250 mg

EXPERIMENTAL

Participants will receive JNJ-41443532 250 mg in morning and evening for 28 days.

Drug: JNJ-41443532; Drug: Placebo

JNJ-41443532 1000 mg

EXPERIMENTAL

Participants will receive JNJ-41443532 1000 mg (4 X 250 mg) in morning and evening for 28 days.

Drug: JNJ-41443532; Drug: Placebo

Pioglitazone

ACTIVE COMPARATOR

Participants will receive pioglitazone 30 mg in morning for 28 days.

Drug: Pioglitazone 30 mg; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo for JNJ-41443532 and pioglitazone for 28 days.

Drug: Placebo

Interventions

JNJ-41443532 DRUG

Participants will receive JNJ-41443532 tablet(s) orally in JNJ-41443532 250 mg arm (1 X 250 mg) and JNJ-41443532 1000 mg arm (4 X 250 mg) in morning and evening, for 28 days.

JNJ-41443532 1000 mg; JNJ-41443532 250 mg

Pioglitazone 30 mg DRUG

Participants will receive tablet pioglitazone 30 mg orally in morning for 28 days.

Pioglitazone

Placebo DRUG

Participants will receive matching placebo tablets of JNJ-41443532 and/or matching placebo tablets of pioglitazone orally as per the assigned arms.

JNJ-41443532 1000 mg; JNJ-41443532 250 mg; Pioglitazone; Placebo

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed Type 2 Diabetes Mellitus (T2DM) for at least 3 months prior screening
• On a stable treatment regimen for at least 2 months prior screening
• Medically stable on the basis of physical examination, medical history, and clinical laboratory tests performed at screening and 2 days before administration of the study medication
• Fasting plasma glucose (FPG) concentrations between 140 mg/dL and 270 mg/dL on 2 days before administration of the study medication
• Agrees to protocol-defined use of effective contraception

You may not qualify if:

• History of other types of diabetes and complications or secondary forms of diabetes
• History of eating disorder or recent significant changes in body weight (ie, more or equal to 5 percent over 3 months prior to screening) due to dieting or nutritional treatments
• Taking antihyperglycemic agents (insulin, exenatide, and liraglutide) within 6 months or thiazolidinedione within 3 months of 2 days before administration of the study medication
• Clinically significant abnormal electrocardiogram
• History of, or currently active, significant illness or medical disorders, retinal disease, tuberculosis
• Clinically important serious infection, positive for serology at screening (hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus antibodies)

Sponsors & Collaborators

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Hyperglycemia

Interventions

JNJ-41443532; Pioglitazone

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Director, Translational Medicine
• Organization: Janssen R&D US

1 908 927-7881

Study Officials

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

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: October 22, 2010
• First Posted: October 29, 2010
• Study Start: December 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 11, 2013
• Results First Posted: December 11, 2013

Record last verified: 2013-10