Diabetes Mellitus, Type 2Phase 1NCT02862431

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

A Phase 1 study testing JNJ-64565111 in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: JNJ-64565111
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteGermany
Study dates: 12 Jul 2016to 5 Dec 2016
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

Germany1 site

Study site
Neuss

Other trials in Germany

About this study

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

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.

Conditions: Diabetes Mellitus, Type 2
Being tested: JNJ-64565111, Placebo
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

JNJ-64565111Drug
Participants will receive JNJ-64565111 subcutaneously in the abdomen on Days 1, 8, 15 and 22.
PlaceboDrug
Participants will receive Placebo subcutaneously in the abdomen on Days 1, 8, 15 and 22.

Study groups in NCT02862431
Study group	Role	What they receive
Cohort 1 (JNJ-64565111 2.5 nmol/kg or Placebo)	Experimental	Participants in ratio of 3:1 will receive 2.5 Nanomole Per Kilogram (nmol/kg) JNJ-64565111 or placebo. Receives: Drug: JNJ-64565111; Drug: Placebo
Cohort 2 (JNJ-64565111 3 nmol/kg or Placebo)	Experimental	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. Receives: Drug: JNJ-64565111; Drug: Placebo
Cohort 3 (JNJ-64565111 3.5 nmol/kg or Placebo)	Experimental	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. Receives: Drug: JNJ-64565111; Drug: Placebo
Cohort 4 (JNJ-64565111 Repeat or Lower Dose or Placebo)	Experimental	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. Receives: Drug: JNJ-64565111; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Measured: Up to Day 72

Secondary outcomes (24)

Number of Participants With Incidence of Anti-JNJ-64565111 Antibodies as Measure of Immunogenicity
Measured: Up to Day 72
Change From Baseline in Body Weight
Measured: Baseline, up to Day 72
Maximum Observed Plasma Concentration (Cmax)
Maximum observed plasma concentration (Cmax) will be assessed after first dose and last dose.
Measured: Up to Day 72
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Tmax defined as actual sampling time to reach maximum observed analyte concentration will be assessed after first dose and last dose.
Measured: Up to Day 72
Area Under Concentration from time zero to the last quantifiable concentration AUC(0-last)
AUC from time zero to the last quantifiable concentration will be assessed after first dose and after last dose.
Measured: Up to Day 72
Area Under Curve over the dosing interval AUC(0-tau)
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.
Measured: Up to Day 72
Elimination Half-Life (t1/2)
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.
Measured: Up to Day 72
Apparent Clearance (CL/F)
The Oral Clearance (CL/F) is the clearance based on oral bioavailability. CL/F will be assessed after first dose and last dose.
Measured: Up to Day 72
Apparent Volume of Distribution (V/F)
Apparent volume of distribution will be assessed after first dose and last dose.
Measured: Up to Day 72
Terminal Rate Constant (K)
Terminal rate constant will be assessed after first dose and last dose.
Measured: Up to Day 72
Average concentration over the dosing interval at steady state (Caverage,ss)
The average concentration over the dosing interval at steady state, calculated as AUC(0-tau)/tau and will be assessed after last dose.
Measured: Up to Day 72
Minimum Observed Plasma Concentration (Cmin)
The Cmin is the minimum observed plasma concentration over the dosing interval at steady state. Cmin will be assessed after last dose.
Measured: Up to Day 72
Area Under Curve from time zero extrapolated to infinity AUC(0-inf)
AUC from time zero extrapolated to infinity will be assessed after last dose.
Measured: Up to Day 72
Accumulation Ratio
Accumulation ratio calculated as AUC(0-tau), Day 22 / AUC(0-tau), Day 1 will be assessed after last dose.
Measured: Up to Day 72
Change From Baseline in Blood Pressure
Measured: Baseline, up to Day 72
Change From Baseline in Heart Rate
Measured: Baseline, up to Day 72
Change From Baseline for 24-hour Mean Plasma Glucose
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.
Measured: Baseline, Day 26
Change From Baseline in Fasting Plasma Glucose (FPG)
Measured: Baseline, up to Day 72
Change From Baseline in Hemoglobin A1c (HbA1c)
Measured: Baseline, up to Day 72
Change From Baseline on Fasting Lipids
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.
Measured: Baseline, up to Day 72
Change From Baseline in Insulin Secretion
Measured: Baseline, Day 26
Change From Baseline in Insulin Sensitivity
Measured: Baseline, Day 26
Change From Baseline for C-peptide
Measured: Baseline, Day 26
Change From Baseline for Glucagon
Measured: Baseline, Day 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jul 20165 Dec 2016

First posted11 Aug 2016 (estimated)
Study start12 Jul 2016
Primary completion29 Nov 2016
Study completion5 Dec 2016

Why it stopped: manufacturing-related issues

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02862431
Sponsor's protocol ID: CR108166
Other IDs: 64565111EDI1001, 2016-001084-37, 2016
Status last verified: Apr 2025
First submitted: 24 Jun 2016
Last updated: 27 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02862431
Acronym / sponsor ID: CR108166
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: manufacturing-related issues
Enrolment: 24 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: 12 Jul 2016 (actual)
Primary completion: 29 Nov 2016 (actual)
Study completion: 5 Dec 2016 (actual)
First posted: 11 Aug 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Cohort 1 (JNJ-64565111 2.5 nmol/kg or Placebo)	Experimental	Drug: JNJ-64565111, Drug: PlaceboParticipants in ratio of 3:1 will receive 2.5 Nanomole Per Kilogram (nmol/kg) JNJ-64565111 or placebo.
Cohort 2 (JNJ-64565111 3 nmol/kg or Placebo)	Experimental	Drug: JNJ-64565111, Drug: PlaceboParticipants 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.
Cohort 3 (JNJ-64565111 3.5 nmol/kg or Placebo)	Experimental	Drug: JNJ-64565111, Drug: PlaceboParticipants 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.
Cohort 4 (JNJ-64565111 Repeat or Lower Dose or Placebo)	Experimental	Drug: JNJ-64565111, Drug: PlaceboParticipants 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.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
JNJ-64565111Participants will receive JNJ-64565111 subcutaneously in the abdomen on Days 1, 8, 15 and 22.	Drug	Cohort 1 (JNJ-64565111 2.5 nmol/kg or Placebo), Cohort 2 (JNJ-64565111 3 nmol/kg or Placebo), Cohort 3 (JNJ-64565111 3.5 nmol/kg or Placebo), Cohort 4 (JNJ-64565111 Repeat or Lower Dose or Placebo)
PlaceboParticipants will receive Placebo subcutaneously in the abdomen on Days 1, 8, 15 and 22.	Drug	Cohort 1 (JNJ-64565111 2.5 nmol/kg or Placebo), Cohort 2 (JNJ-64565111 3 nmol/kg or Placebo), Cohort 3 (JNJ-64565111 3.5 nmol/kg or Placebo), Cohort 4 (JNJ-64565111 Repeat or Lower Dose or Placebo)

Primary outcome

Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to Day 72

24 secondary outcomes

Number of Participants With Incidence of Anti-JNJ-64565111 Antibodies as Measure of Immunogenicity
Time frame: Up to Day 72
Change From Baseline in Body Weight
Time frame: Baseline, up to Day 72
Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to Day 72
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Up to Day 72
Area Under Concentration from time zero to the last quantifiable concentration AUC(0-last)
Time frame: Up to Day 72
Area Under Curve over the dosing interval AUC(0-tau)
Time frame: Up to Day 72
Elimination Half-Life (t1/2)
Time frame: Up to Day 72
Apparent Clearance (CL/F)
Time frame: Up to Day 72
Apparent Volume of Distribution (V/F)
Time frame: Up to Day 72
Terminal Rate Constant (K)
Time frame: Up to Day 72
Average concentration over the dosing interval at steady state (Caverage,ss)
Time frame: Up to Day 72
Minimum Observed Plasma Concentration (Cmin)
Time frame: Up to Day 72
Area Under Curve from time zero extrapolated to infinity AUC(0-inf)
Time frame: Up to Day 72
Accumulation Ratio
Time frame: Up to Day 72
Change From Baseline in Blood Pressure
Time frame: Baseline, up to Day 72
Change From Baseline in Heart Rate
Time frame: Baseline, up to Day 72
Change From Baseline for 24-hour Mean Plasma Glucose
Time frame: Baseline, Day 26
Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame: Baseline, up to Day 72
Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, up to Day 72
Change From Baseline on Fasting Lipids
Time frame: Baseline, up to Day 72
Change From Baseline in Insulin Secretion
Time frame: Baseline, Day 26
Change From Baseline in Insulin Sensitivity
Time frame: Baseline, Day 26
Change From Baseline for C-peptide
Time frame: Baseline, Day 26
Change From Baseline for Glucagon
Time frame: Baseline, Day 26

Results and safety

The study was stopped early (reason given: manufacturing-related issues). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janssen Research & Development, LLC Clinical Trial study director

Janssen Research & Development, LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-64565111 in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: manufacturing-related issues). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events as a Measure of Safety and Tolerability (time frame: Up to Day 72). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02862431.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.