Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of JNJ-38431055 in Volunteers With Type 2 Diabetes Mellitus

This study has been terminated.
(No safety signals were noted. The study completed the main phase, additional potential study cohorts not required.)
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00946972
First received: July 23, 2009
Last updated: March 4, 2010
Last verified: March 2010

July 23, 2009
March 4, 2010
July 2009
Not Provided
Adverse events, laboratory values, vital signs, ECGs [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00946972 on ClinicalTrials.gov Archive Site
  • 24 hour weighted mean glucose [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Fasting plasma glucose, glycosylated albumin [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Dose response [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Measures of beta-cell function [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Incretin levels [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of JNJ-38431055 in Volunteers With Type 2 Diabetes Mellitus
Multiple Dose Study in T2DM

This study will assess the safety, tolerability, pharmacokinetics (explores what the body does to the drug), and pharmacodynamics (explores what a drug does to the body) of multiple doses of JNJ-38431055 in volunteers with type 2 diabetes mellitus.

This is a double-blind (neither physician or participant knows the name of the assigned study drug), placebo-controlled (substance containing no medication), study in male and female volunteers with type 2 diabetes mellitus. For each volunteer, the study consists of a screening phase (up to 45 days), a run-in phase during which volunteers discontinue their oral anti-hyperglycemic drugs (21 to 35 days), a treatment phase during which volunteers will continue to be off their anti-hyperglycemic drugs and receive daily study drug (JNJ-38431055 or placebo) for 14 days, and a follow-up phase (10 days). After the follow-up phase, volunteers will restart their oral anti-hyperglycemic drugs. The following safety evaluations will be taken throughout the study: Electrocardiogram (an ECG is a painless procedure that gives a picture of the electrical activity of the heart), blood pressure, heart rate, and blood samples for laboratory tests. The primary outcomes will be safety and tolerability of JNJ-38431055 and 24-hour weighted mean glucose concentrations after 14 days of dosing with JNJ-38431055. Study drug will be administered as daily doses for 14 days. The two treatments will be JNJ-38431055 and placebo.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: JNJ-38431055; Placebo
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
33
November 2009
Not Provided

Inclusion Criteria:

  • Males or postmenopausal or surgically sterilized females, who have type 2 diabetes mellitus
  • Medically stable on the basis of physical examination, medical history, laboratory safety test results, vital signs and ECG performed at screening
  • Body Mass Index (BMI) between 22 and 39.9 kg/m2, inclusive
  • On a generally stable antihyperglycemic agent regimen (i.e. with no change in medication, or only 1 dose step change in dose) for at least 2 months prior to Screening visit, including volunteers who are: (a) Not currently on antihyperglycemic therapy and have an HbA1c >=7.0 % and <=10%, or (b) On a single oral antihyperglycemic agent [metformin, a sunfonylurea, a meglitinide (e.g., repaglininide or nateglinide), a DPP-IV inhibitor (sitagliptin or vildagliptin), or an alpha-glucosidase inhibitor (e.g., acarbose)] and have an HbA1c >=6.5% and <=9.5%, or (c) On low-dose dual oral agent therapy (i.e., <50% maximum labeled doses of both agents) and have an HbA1c >=6.5% and <=9.5%
  • On Day -2 (two days prior to study drug administration), FPG concentrations between 120 mg/dL and 260 mg/dL, inclusive

Exclusion Criteria:

  • Taking non-oral antihyperglycemic agent (e.g., insulin, exenatide or other GLP-1 analogues), or taking a thiazolidinedione (i.e., a PPARg agonist) within 3 months of the Screening visit
  • History of a recent severe hypoglycemic episode, recurrent hypoglycemic episodes (i.e., within the past year), or a history of hypoglycemic unawareness
  • History of clinically significant diabetic complications, including retinopathy, nephropathy, neuropathy or gastroparesis
  • Positive test for alcohol and/or drugs of abuse
  • Psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the volunteer to comply with the study requirements
  • Any condition that, in the opinion of the investigator, would compromise the well being of the volunteer or the study or prevent the volunteer from meeting or performing study requirements
Both
25 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00946972
CR016447
No
Clinical Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Not Provided
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP