A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (Explores What the Body Does to the Drug), and Pharmacodynamics (Explores What a Drug Does to the Body) of JNJ-38431055 in Volunteers With Type 2 Diabetes Mellitus

NCT00871507 | Completed Phase 1

• 1 other identifier: CR016048
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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 JNJ-38431055 in volunteers with type 2 diabetes mellitus.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Incremental glucose AUC after an oral glucose tolerance test (OGTT)

  0-4 hours after OGTT

Secondary Outcomes (5)

• Incremental glucose AUC after a meal tolerance test (MTT)

  0-4 hours after MTT

• Measurements of beta-cell function

  0-4 hours after OGTT/MTT

• Effect on incretin levels

  0-4 hours after OGTT

• Pharmacokinetics

  48 hours after dosing

• Safety and Tolerability

  Throughout study

Study Arms (4)

001

EXPERIMENTAL

Drug: JNJ-38431055 Dose 1

002

EXPERIMENTAL

Drug: JNJ-38431055 Dose 2

003

PLACEBO COMPARATOR

Drug: Placebo

004

ACTIVE COMPARATOR

Drug: Sitagliptin 100 mg

Interventions

JNJ-38431055 Dose 1 DRUG

Liquid suspension/solution of JNJ-38431055 administered as a single dose

001

Sitagliptin 100 mg DRUG

Capsule containing 100 mg of sitagliptin administered as a single dose.

004

Placebo DRUG

Placebo suspension/solution and Placebo capsule administered as single doses

003

JNJ-38431055 Dose 2 DRUG

Liquid suspension/solution of JNJ-38431055 administered as a single dose

002

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 the Screening Visit, including volunteers who are:(a) Not currently on antihyperglycemic therapy and have an HbA1c =7.0% and =10.0%, or (b) On a single oral antihyperglycemic agent \[metformin, a sulfonylurea, a meglitinide (e.g., repaglininide or nateglinide), a DPP-4 inhibitor (sitagliptin or vildagliptin), or an alpha-glucosidase inhibitor (e.g., acarbose)\] 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 -1, 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 Day -1
• 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

Study Sites (2)

Unknown Facility

Fort Myers, Florida, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: March 30, 2009
• Study Start: April 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: May 22, 2014

Record last verified: 2014-05

Locations

US (2)