Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-64565111 in Type 2 Diabetes Mellitus (T2DM)

Janssen (J&J Innovative Medicine)

Status and phase: Terminated; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: JNJ-64565111

Study type: Interventional

Funder types: Industry

Identifiers

NCT02862431

CR108166

64565111EDI1001 (Other Identifier)

2016-001084-37 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 4 patient groups

Cohort 1 (JNJ-64565111 2.5 nmol/kg or Placebo)

Experimental group

Description:

Participants in ratio of 3:1 will receive 2.5 Nanomole Per Kilogram (nmol/kg) JNJ-64565111 or placebo.

Treatment:

Drug: JNJ-64565111

Drug: Placebo

Cohort 2 (JNJ-64565111 3 nmol/kg or Placebo)

Experimental group

Description:

Participants in ratio of 3:1 will receive 3.0 nmol/kg JNJ-64565111 or placebo. Dose may be escalated based on review by Sponsor and Principal Investigator of blinded safety, tolerability, pharmacokinetic, and (all available) pharmacodynamic data collected up to Day 29 but dose will not exceed 3.5 nmol/kg.

Treatment:

Drug: JNJ-64565111

Drug: Placebo

Cohort 3 (JNJ-64565111 3.5 nmol/kg or Placebo)

Experimental group

Description:

Participants in ratio of 3:1 will receive 3.5 nmol/kg JNJ-64565111 or placebo. Dose may be escalated based on review by Sponsor and Principal Investigator of blinded safety, tolerability, pharmacokinetic, and (all available) pharmacodynamic data collected up to Day 29 but dose will not exceed 3.5 nmol/kg.

Treatment:

Drug: JNJ-64565111

Drug: Placebo

Cohort 4 (JNJ-64565111 Repeat or Lower Dose or Placebo)

Experimental group

Description:

Participants in ratio of 3:1 will receive a dose of JNJ-64565111 or placebo that would be a repeat or lower dose level previously assessed as well-tolerated.

Treatment:

Drug: JNJ-64565111

Drug: Placebo