AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 1NCT04575181

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

A Phase 1 study testing NNC0268-0965 and Insulin glargine in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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®). Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
NNC0268-0965 and Insulin glargine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
86 participants
Where
2 sitesGermany
Study dates
21 Oct 2020to 24 Dec 2021
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 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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%

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Profil GmbH & Co. KG

    Mainz, 55116

  • Profil Institut für Stoffwechselforschung GmbH

    Neuss, 41460

Other trials in Germany

About this study

Official title: 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.

Being tested
NNC0268-0965, Insulin glargine, Placebo (NNC0268-0965), Placebo (insulin glargine)
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.

  • NNC0268-0965Drug

    For subcutaneous (s.c., under the skin) injection once daily for 26 weeks

  • Insulin glargineDrug

    For s.c. injection once daily for 26 weeks

  • Placebo (NNC0268-0965)Drug

    For s.c. injection once daily for 26 weeks

  • Placebo (insulin glargine)Drug

    For s.c. injection once daily for 26 weeks

Study groups in NCT04575181
Study groupRoleWhat they receive
NNC0286-0965ExperimentalNNC0286-0965 administered together with insulin glargine placebo. If previously treated with oral anti-diabetic drugs (OADs), participants will remain on these in the trial
Receives: Drug: NNC0268-0965; Drug: Placebo (insulin glargine)
Insulin glargineActive comparatorInsulin glargine administered together with NNC0286-0965 placebo. If previously treated with OADs, participants will remain on these in the trial
Receives: Drug: Insulin glargine; Drug: Placebo (NNC0268-0965)

What is being measured

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

  1. Change in flow mediated dilation

    Percent

    Measured: From Visit 3B (week 0) to visit 30B (week 26)

Secondary outcomes (13)

  1. Change in pulse wave velocity

    m/s

    Measured: From Visit 3B (week 0) to visit 30B (week 26)

  2. Change in leg blood flow

    ml/100 ml/min

    Measured: From Visit 3B (week 0) to visit 30B (week 26)

  3. Change in retinal arteriolar dilation

    Percent

    Measured: From Visit 3A (week 0) to visit 30A (week

  4. Relative change in liver fat percentage measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF)

    Ratio

    Measured: From Visit 2 (week 0) to visit 29 (week 26)

  5. Change in left ventricular ejection fraction

    Percent

    Measured: From Visit 2 (week 0) to visit 29 (week 26)

  6. Change in glycosylated haemoglobin (HbA1c )

    Percent

    Measured: From Visit 3B (week 0) to visit 30B (week 26)

  7. Change in body weight

    kg

    Measured: From Visit 3B (week 0) to visit 30B (week 26)

  8. Change in body fat mass as measured by BOD POD (a method for determining the lean body mass)

    Percent

    Measured: From Visit 3B (week 0) to visit 30B (week 26)

  9. Relative change in rate of glucose disposal at short Insulin Tolerance Test

    Ratio

    Measured: From Visit 3B (week 0) to visit 30B (week 26)

  10. Number of adverse events

    Number of events

    Measured: From Visit 3B (week 0) to visit 30B (week 26)

  11. Number of severe hypoglycaemic episodes (level 3)

    Number of episodes

    Measured: From Visit 3B (week 0) to visit 30B (week 26)

  12. 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)

    Number of episodes

    Measured: From Visit 3B (week 0) to visit 30B (week 26)

  13. Number of clinically significant hypoglycaemic episodes s (level 2) ((below 3.0 mmol/L (54 mg/dL), confirmed by BG meter)

    Number of episodes

    Measured: From Visit 3B (week 0) to visit 30B (week 26)

Timeline

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

  1. First posted5 Oct 2020
  2. Study start21 Oct 2020
  3. Primary completion10 Dec 2021
  4. Study completion24 Dec 2021

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04575181
Sponsor's protocol ID
NN1965-4485
Other IDs
U1111-1243-0598, 2019-004381-18, 2019
Status last verified
Jan 2024
First submitted
28 Sep 2020
Last updated
10 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NNC0268-0965 and Insulin glargine in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 2 sites 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 10 inclusion and 13 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: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in flow mediated dilation (time frame: From Visit 3B (week 0) to visit 30B (week 26)). 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 NCT04575181.

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 10 Jan 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT04575181 | AzTrials