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

NCT00946972 | Terminated Phase 1

• 1 other identifier: CR016447
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Adverse events, laboratory values, vital signs, ECGs

  Throughout the study

Secondary Outcomes (5)

• 24 hour weighted mean glucose

  24 hours

• Fasting plasma glucose, glycosylated albumin

  14 days

• Dose response

  14 days

• Measures of beta-cell function

  14 days

• Incretin levels

  14 days

Interventions

JNJ-38431055; Placebo DRUG

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

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: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 23, 2009
• First Posted: July 27, 2009
• Study Start: July 1, 2009
• Study Completion: November 1, 2009
• Last Updated: March 5, 2010

Record last verified: 2010-03