Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DRUGJNJ-64565111
Participants will receive JNJ-64565111 subcutaneously in the abdomen on Days 1, 8, 15 and 22.
DRUGPlacebo
Participants will receive Placebo subcutaneously in the abdomen on Days 1, 8, 15 and 22.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Up to Day 72 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Body Weight | Baseline, up to Day 72 | — |
| Maximum Observed Plasma Concentration (Cmax) | Up to Day 72 | Maximum observed plasma concentration (Cmax) will be assessed after first dose and last dose. |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Up to Day 72 | Tmax defined as actual sampling time to reach maximum observed analyte concentration will be assessed after first dose and last dose. |
| Area Under Concentration from time zero to the last quantifiable concentration AUC(0-last) | Up to Day 72 | AUC from time zero to the last quantifiable concentration will be assessed after first dose and after last dose. |
| Area Under Curve over the dosing interval AUC(0-tau) | Up to Day 72 | The AUC \[0-tau\] is the measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption. AUC \[0-tau\] will be assessed after first dose and last dose. |
| Elimination Half-Life (t1/2) | Up to Day 72 | The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. t1/2 will be assessed after first dose and last dose. |
| Apparent Clearance (CL/F) | Up to Day 72 | The Oral Clearance (CL/F) is the clearance based on oral bioavailability. CL/F will be assessed after first dose and last dose. |
| Apparent Volume of Distribution (V/F) | Up to Day 72 | Apparent volume of distribution will be assessed after first dose and last dose. |
| Terminal Rate Constant (K) | Up to Day 72 | Terminal rate constant will be assessed after first dose and last dose. |
| Average concentration over the dosing interval at steady state (Caverage,ss) | Up to Day 72 | The average concentration over the dosing interval at steady state, calculated as AUC(0-tau)/tau and will be assessed after last dose. |
| Minimum Observed Plasma Concentration (Cmin) | Up to Day 72 | The Cmin is the minimum observed plasma concentration over the dosing interval at steady state. Cmin will be assessed after last dose. |
| Number of Participants With Incidence of Anti-JNJ-64565111 Antibodies as Measure of Immunogenicity | Up to Day 72 | — |
| Accumulation Ratio | Up to Day 72 | Accumulation ratio calculated as AUC(0-tau), Day 22 / AUC(0-tau), Day 1 will be assessed after last dose. |
| Change From Baseline in Blood Pressure | Baseline, up to Day 72 | — |
| Change From Baseline in Heart Rate | Baseline, up to Day 72 | — |
| Change From Baseline for 24-hour Mean Plasma Glucose | Baseline, Day 26 | Mean plasma glucose defined as the total and/or incremental area under the concentration (AUC) time curve over 0 to 24 hours, divided by 24. |
| Change From Baseline in Fasting Plasma Glucose (FPG) | Baseline, up to Day 72 | — |
| Change From Baseline in Hemoglobin A1c (HbA1c) | Baseline, up to Day 72 | — |
| Change From Baseline on Fasting Lipids | Baseline, up to Day 72 | Total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), very low-density lipoprotein cholesterol (VLDL-C), triglycerides and free fatty acids will be reported. |
| Change From Baseline in Insulin Secretion | Baseline, Day 26 | — |
| Change From Baseline in Insulin Sensitivity | Baseline, Day 26 | — |
| Change From Baseline for C-peptide | Baseline, Day 26 | — |
| Change From Baseline for Glucagon | Baseline, Day 26 | — |
| Area Under Curve from time zero extrapolated to infinity AUC(0-inf) | Up to Day 72 | AUC from time zero extrapolated to infinity will be assessed after last dose. |
Countries
Germany
Outcome results
None listed