Back to resultsA 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
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
JNJ-38431055 Dose 1
Sitagliptin 100 mg
Placebo
JNJ-38431055 Dose 2
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2
Eligibility Criteria
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 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.
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 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Active Comparator
Arm Label
001
002
003
004
Arm Description
Outcomes
Primary Outcome Measures
Incremental glucose AUC after an oral glucose tolerance test (OGTT)
Secondary Outcome Measures
Incremental glucose AUC after a meal tolerance test (MTT)
Measurements of beta-cell function
Effect on incretin levels
Pharmacokinetics
Safety and Tolerability
Full Information
NCT ID
NCT00871507
First Posted
March 26, 2009
Last Updated
May 21, 2014
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1. Study Identification
Unique Protocol Identification Number
NCT00871507
Brief Title
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
Official Title
SD in Subjects With T2DM
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This is a double-blind (neither physician or participant knows name of the assigned study drug), placebo-controlled (substance containing no medication), crossover 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 hypoglycemic drugs (28 days), a treatment phase during which volunteers will continue to be off their oral hypoglycemic drugs (28 days) and will receive 4 single dose study treatments in a randomized (study sequence assigned by chance) sequence, and a follow-up phase (10 days). After the follow-up phase volunteers will restart their oral hypoglycemic drugs. During the treatment phase there will be at least 7 days between each of the 4 treatments. The four treatments will be Dose 1 of JNJ-38431055, Dose 2 of JNJ-38431055, sitagliptin (Januvia), and placebo. 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 outcome will be incremental glucose after an oral glucose tolerance test. Study drug will be administered as single oral doses separated by at least 7 days. The four treatments will be Dose 1 of JNJ-38431055, Dose 2 of JNJ-38431055, sitagliptin (Januvia), and placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
001
Arm Type
Experimental
Arm Title
002
Arm Type
Experimental
Arm Title
003
Arm Type
Placebo Comparator
Arm Title
004
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
JNJ-38431055 Dose 1
Intervention Description
Liquid suspension/solution of JNJ-38431055 administered as a single dose
Intervention Type
Drug
Intervention Name(s)
Sitagliptin 100 mg
Intervention Description
Capsule containing 100 mg of sitagliptin administered as a single dose.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo suspension/solution and Placebo capsule administered as single doses
Intervention Type
Drug
Intervention Name(s)
JNJ-38431055 Dose 2
Intervention Description
Liquid suspension/solution of JNJ-38431055 administered as a single dose
Primary Outcome Measure Information:
Title
Incremental glucose AUC after an oral glucose tolerance test (OGTT)
Time Frame
0-4 hours after OGTT
Secondary Outcome Measure Information:
Title
Incremental glucose AUC after a meal tolerance test (MTT)
Time Frame
0-4 hours after MTT
Title
Measurements of beta-cell function
Time Frame
0-4 hours after OGTT/MTT
Title
Effect on incretin levels
Time Frame
0-4 hours after OGTT
Title
Pharmacokinetics
Time Frame
48 hours after dosing
Title
Safety and Tolerability
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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.
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
Facility Information:
City
Fort Myers
State/Province
Florida
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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
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