Clinical trial NCT02862431: Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-64565111 in Type 2 Diabetes Mellitus (T2DM)
Official title: A Double-Blind, Randomized, Placebo-Controlled, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-64565111 in Men and Women With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2016-08-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and tolerability of JNJ-64565111 in adult Men and Women (of non-child bearing potential) with Type 2 Diabetes Mellitus.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Type 2 Diabetes Mellitus (T2DM) at least 3 months prior to Screening
* On a stable treatment regimen at least 3 months prior to Screening of (1) diet and exercise, or (2) metformin monotherapy (at a dose of at least 1,000 milligram (mg) per day)
* Blood pressure between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and between 60 and 100 mmHg diastolic, inclusive at Screening (sitting) and Day -2 (supine). If blood pressure is out of range, up to 2 repeated assessments are permitted
* HbA1c greater than or equal to 6.5% and less than 8.5% at Screening
* Females of non-childbearing potential

Exclusion Criteria:

* History of, or currently active, significant illness or medical disorders, including cardiovascular disease (including cardiac arrhythmias, myocardial infarction, stroke, peripheral vascular disease), hematological disease (example, von Willebrand's disease or other bleeding disorders), respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmologic disorders, neoplastic disease, skin disorder, renal disorder, or any other illness that the Principal Investigator (PI) considers should exclude the participant or that could interfere with the interpretation of the study results
* Previous surgical treatment for obesity (example, gastric bypass, gastric banding)
* History of diabetic neuropathy with signs of gastroparesis and/or known proliferative retinopathy or maculopathy
* History or current diagnosis of acute or chronic pancreatitis
* History of an invasive cardiovascular surgical procedure including, but not limited to, coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI)

Primary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to Day 72
Secondary outcomes:
measure: Number of Participants With Incidence of Anti-JNJ-64565111 Antibodies as Measure of Immunogenicity
timeFrame: Up to Day 72
measure: Change From Baseline in Body Weight
timeFrame: Baseline, up to Day 72
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Up to Day 72
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Up to Day 72
measure: Area Under Concentration from time zero to the last quantifiable concentration AUC(0-last)
timeFrame: Up to Day 72
measure: Area Under Curve over the dosing interval AUC(0-tau)
timeFrame: Up to Day 72
measure: Elimination Half-Life (t1/2)
timeFrame: Up to Day 72
measure: Apparent Clearance (CL/F)
timeFrame: Up to Day 72
measure: Apparent Volume of Distribution (V/F)
timeFrame: Up to Day 72
measure: Terminal Rate Constant (K)
timeFrame: Up to Day 72
measure: Average concentration over the dosing interval at steady state (Caverage,ss)
timeFrame: Up to Day 72
measure: Minimum Observed Plasma Concentration (Cmin)
timeFrame: Up to Day 72
measure: Area Under Curve from time zero extrapolated to infinity AUC(0-inf)
timeFrame: Up to Day 72
measure: Accumulation Ratio
timeFrame: Up to Day 72
measure: Change From Baseline in Blood Pressure
timeFrame: Baseline, up to Day 72
measure: Change From Baseline in Heart Rate
timeFrame: Baseline, up to Day 72
measure: Change From Baseline for 24-hour Mean Plasma Glucose
timeFrame: Baseline, Day 26
measure: Change From Baseline in Fasting Plasma Glucose (FPG)
timeFrame: Baseline, up to Day 72
measure: Change From Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, up to Day 72
measure: Change From Baseline on Fasting Lipids
timeFrame: Baseline, up to Day 72
measure: Change From Baseline in Insulin Secretion
timeFrame: Baseline, Day 26
measure: Change From Baseline in Insulin Sensitivity
timeFrame: Baseline, Day 26
measure: Change From Baseline for C-peptide
timeFrame: Baseline, Day 26
measure: Change From Baseline for Glucagon
timeFrame: Baseline, Day 26
Other outcomes:
Locations:
city: Neuss
country: Germany
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: