A Clinical Study to Compare the Efficacy and Safety of a Novel Medicine (NNC0268-0965) With Insulin Glargine

January 9, 2024 updated by: Novo Nordisk A/S

A Multiple Dose, Randomised, Double Blinded, Double Dummy Trial Investigating Efficacy and Safety of NNC0268-0965 Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus

The study will look at the efficacy and safety of NNC0268-0965 (referred to as insulin 965). The study aims to show that insulin 965 has positive effects on the blood vessels. Participants will get either the new insulin 965 or insulin glargine - a medicine that doctors already can prescribe (Lantus®). Which treatment participants get is decided by chance. Participants will self-administer 2 injections per day under the skin of the thighs for 26 weeks. Study participation will last for about 32 weeks. Participants will have 15 clinic visits, 2 magnetic resonance imaging (MRI) visits and 14 phone calls with the study doctor. There will be a number of in-house assessments to study the effect of the new insulin. The assessments will be explained later in detail. The treatment of disease is not an aim of this study. Participants cannot be in the study if the study doctor thinks that there are risks for their health. Women can only take part in the study if they are not able to become pregnant.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mainz, Germany, 55116
        • Profil GmbH & Co. KG
      • Neuss, Germany, 41460
        • Profil Institut für Stoffwechselforschung GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Informed consent obtained before any trial related activities. Trial related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
  • Aged 40-75 years (both inclusive) at the time of signing informed consent.
  • Diagnosed with diabetes mellitus, type 2 (T2DM) at least 180 days prior to the day of screening.
  • Male subject or female subject of non-childbearing potential. Non-childbearing potential being surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy or being postmenopausal (as defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.
  • HbA1c at screening between 6.0 and 10.0%, both inclusive.
  • Treated with or without any oral antidiabetic agents including any metformin formulations, dipeptidyl peptidase 4 (DPP-4) inhibitors, Sodium-glucose co-transporter-2 (SGLT-2) inhibitors, alpha glucosidase inhibitors, sulfonylureas (including meglitinides). If treated with oral antidiabetic agents, the total daily dose must have been stable within the past 30 days prior to the day of screening.
  • Treated with basal insulin regimen at least 90 days prior to the day of screening with a total daily dose of:
  • equal to or above 10U/day if HbA1c above 7.5%
  • equal to or above 15U/day if HbA1c above 6.5% and equal to or below 7.5%
  • equal to or above 25U/day if HbA1c equal to or below 6.5%

Exclusion Criteria:

  • Previous exposure to insulin 287 formulation A (i.e. trial NN1436-4057).
  • Any of the following which in the investigator's opinion might jeopardise subject's safety or interfere in relation to the magnetic resonance scans: metallic implants, pacemaker, defibrillator, artificial valves in heart, internal electrical devices (e.g. cochlear implant, nerve stimulator, brain stimulator, gastric pacemaker, bladder stimulator etc.) magnetic clips, confirmed claustrophobia or permanent makeup, working or has worked as a metal worker or welder.

Note: Up to 18 subjects, who are not able to have the MRI scan performed, will be allowed inclusion, at the investigator's discretion.

-. Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days to the day of screening.

  • Presently classified as being in New York Heart Association (NYHA) Class III or IV.
  • Renal impairment measured as an Estimated Glomerular Filtration Rate (eGFR) value of below 45.0 mL/min/1.73 m^2 as defined by Kidney Disease Improving Global Outcomes (KDIGO) 2012 at screening.
  • Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
  • Inadequately treated BP defined as Grade 3 hypertension or higher (Systolic equal to or above 160 mmHg or diastolic equal to or a bove 100 mmHg) at screening based upon mean blood pressure of the last 2 of 3 measurements.
  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 30 days or 5 times the half-life of the product, whichever timeframe is longest prior to the day of screening.
  • Planned initiation of concomitant medications known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemically effective corticosteroids).
  • Use of statins (unless the use of these has been stable during the past 3 months) or use of systemically effective corticosteroids, monoamine oxidase (MAO) inhibitors, systemic non-selective beta-blockers, growth hormone, non-routine vitamins or herbal products at screening.
  • Rotating or permanent night shift worker.
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NNC0286-0965
NNC0286-0965 administered together with insulin glargine placebo. If previously treated with oral anti-diabetic drugs (OADs), participants will remain on these in the trial
Drug: NNC0268-0965
For subcutaneous (s.c., under the skin) injection once daily for 26 weeks
Drug: Placebo (insulin glargine)
For s.c. injection once daily for 26 weeks
Active Comparator: Insulin glargine
Insulin glargine administered together with NNC0286-0965 placebo. If previously treated with OADs, participants will remain on these in the trial
Drug: Insulin glargine
For s.c. injection once daily for 26 weeks
Drug: Placebo (NNC0268-0965)
For s.c. injection once daily for 26 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in flow mediated dilation
Time Frame: From Visit 3B (week 0) to visit 30B (week 26)
Percent
From Visit 3B (week 0) to visit 30B (week 26)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in pulse wave velocity
Time Frame: From Visit 3B (week 0) to visit 30B (week 26)
m/s
From Visit 3B (week 0) to visit 30B (week 26)
Change in leg blood flow
Time Frame: From Visit 3B (week 0) to visit 30B (week 26)
ml/100 ml/min
From Visit 3B (week 0) to visit 30B (week 26)
Change in retinal arteriolar dilation
Time Frame: From Visit 3A (week 0) to visit 30A (week
Percent
From Visit 3A (week 0) to visit 30A (week
Relative change in liver fat percentage measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Time Frame: From Visit 2 (week 0) to visit 29 (week 26)
Ratio
From Visit 2 (week 0) to visit 29 (week 26)
Change in left ventricular ejection fraction
Time Frame: From Visit 2 (week 0) to visit 29 (week 26)
Percent
From Visit 2 (week 0) to visit 29 (week 26)
Change in glycosylated haemoglobin (HbA1c )
Time Frame: From Visit 3B (week 0) to visit 30B (week 26)
Percent
From Visit 3B (week 0) to visit 30B (week 26)
Change in body weight
Time Frame: From Visit 3B (week 0) to visit 30B (week 26)
kg
From Visit 3B (week 0) to visit 30B (week 26)
Change in body fat mass as measured by BOD POD (a method for determining the lean body mass)
Time Frame: From Visit 3B (week 0) to visit 30B (week 26)
Percent
From Visit 3B (week 0) to visit 30B (week 26)
Relative change in rate of glucose disposal at short Insulin Tolerance Test
Time Frame: From Visit 3B (week 0) to visit 30B (week 26)
Ratio
From Visit 3B (week 0) to visit 30B (week 26)
Number of adverse events
Time Frame: From Visit 3B (week 0) to visit 30B (week 26)
Number of events
From Visit 3B (week 0) to visit 30B (week 26)
Number of severe hypoglycaemic episodes (level 3)
Time Frame: From Visit 3B (week 0) to visit 30B (week 26)
Number of episodes
From Visit 3B (week 0) to visit 30B (week 26)
Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
Time Frame: From Visit 3B (week 0) to visit 30B (week 26)
Number of episodes
From Visit 3B (week 0) to visit 30B (week 26)
Number of clinically significant hypoglycaemic episodes s (level 2) ((below 3.0 mmol/L (54 mg/dL), confirmed by BG meter)
Time Frame: From Visit 3B (week 0) to visit 30B (week 26)
Number of episodes
From Visit 3B (week 0) to visit 30B (week 26)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Transparency (1452), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 21, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 24, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN1965-4485
  • U1111-1243-0598 (Other Identifier: World Health Organization (WHO))
  • 2019-004381-18 (Registry Identifier: European Medicines Agency (EudraCT))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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