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Trial · Interventional

CompletedPhase 2Results postedRegistry data

A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes

NCTNCT05144984 (opens ClinicalTrials.gov in a new tab)Other idNN9389-4606Other idU1111-1259-2741Other id2020-004863-14Other idjRCT2031210474
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
500 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
9 countries

United States, Bulgaria, Denmark, Greece, Hungary, Japan, Poland, Russia, Serbia

Start
29 Nov 2021
Primary completion
13 Feb 2023
Completion
23 Mar 2023
First posted
6 Dec 2021
Last update posted
9 Apr 2026
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2021202220232024
  1. Ph 2

    A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes

    NCT05144984

    29 Nov 2021 to 23 Mar 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study is looking at semaglutide in combination with a potential new medicine (NNC0480-0389) in people with type 2 diabetes. The study is being conducted to see how well semaglutide, in combination with different doses of NNC0480-0389, work to lower blood sugar levels. Results from this study will be used to select the doses of the two medicines for other studies. Participants will either get: Semaglutide (a medicine doctors can already prescribe for treatment of type 2 diabetes) in combination with NNC0480-0389 (a potential new medicine) or placebo (a 'dummy' medicine that looks like the medicines but without any medicine). NNC0480-0389 alone, or semaglutide alone which treatment participant get is decided by chance. Participant will need to take 2-3 injections once every week during the study. One injection will be with semaglutide or placebo and 1-2 injections will be with NNC0480-0389 or placebo. Participant must inject the study medicines themself into the stomach, thigh, or upper arm. The study will last for about 41weeks. Participant will have 20 clinic visits. Participant will have blood samples taken at all clinic visits. At 3 clinic visits, participant will also have an electrocardiogram (ECG). This is a test to check participants heart. Participant will have their eyes checked before or at the start of the study and at the end of the study. Women can only take part in the study if they are not able to become pregnant

Interventions

  • NNC0480-0389Drug
  • SemaglutideDrug
  • Placebo (NNC080-0389)Drug
  • Placebo (semaglutide)Drug

Arms10

  • Experimental

    2.4 mg semaglutide + 2.4 mg NNC0480-0389

    subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide.

  • Placebo comparator

    Placebo (semaglutide) + placebo ( 2.4 mg NNC0480-0389)

    subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).

  • Experimental

    2.4 mg semaglutide + 7.2 mg NNC0480-0389

    subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide

  • Experimental

    2.4 mg semaglutide + 12.0 mg NNC0480-0389

    subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide

  • Experimental

    2.4 mg semaglutide + 21.6 mg NNC0480-0389

    subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide

  • Experimental

    NNC0480-0389 + placebo (semaglutide)

    subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. placebo (semaglutide)

  • Placebo comparator

    Placebo (semaglutide) + placebo ( 7.2 mg NNC0480-0389)

    subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).

  • Placebo comparator

    Placebo (semaglutide) + placebo ( 12.0 mg NNC0480-0389)

    subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).

  • Placebo comparator

    Placebo (semaglutide) + placebo ( 21.6 mg NNC0480-0389)

    subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).

  • Experimental

    Semaglutide 2.4 mg + placebo (NNC0480-0389)

    subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. semaglutide.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Glycosylated Haemoglobin (HbA1c)

    Time frame · Baseline (week 0), (week 34)

    Registry description

    Change from baseline (week 0) to week 34 in HbA1c is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.

Secondary outcomes(14)

  1. Change From Baseline in Fasting Plasma Glucose (FPG)

    Time frame · Baseline (week 0), (week 34)

    Registry description

    Change from baseline (week 0) to week 34 in FPG is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.

  2. Change From Baseline in Body Weight (Kilogram [kg])

    Time frame · Baseline (week 0), (week 34)

    Registry description

    Change from baseline (week 0) to week 34 in body weight is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.

  3. Percent Change From Baseline in Body Weight

    Time frame · Baseline (week 0), (week 34)

    Registry description

    Percent change from baseline (week 0) to week 34 in body weight (measured in Kgs) is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.

  4. Change From Baseline in Waist Circumference

    Time frame · Baseline (week 0), (week 34)

    Registry description

    Change from baseline (week 0) to week 34 in waist circumference is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.

  5. Change From Baseline in Systolic Blood Pressure (SBP)

    Time frame · Baseline (week 0), (week 34)

    Registry description

    Change from baseline (week 0) to week 34 in systolic blood pressure is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.

  6. Relative Change From Baseline in Total Cholesterol - Ratio to Baseline

    Time frame · Baseline (week 0), (week 34)

    Registry description

    Change from baseline (week 0) to week 34 in total cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.

  7. Relative Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline

    Time frame · Baseline (week 0), (week 34)

    Registry description

    Change from baseline (week 0) to week 34 in HDL cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.

  8. Relative Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline

    Time frame · Baseline (week 0), (week 34)

    Registry description

    Change from baseline (week 0) to week 34 in LDL cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.

  9. Relative Change From Baseline in Very-Low Density Lipoprotein (VLDL) Cholesterol - Ratio to Baseline

    Time frame · Baseline (week 0), (week 34)

    Registry description

    Change from baseline (week 0) to week 34 in VLDL cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.

  10. Relative Change From Baseline in Triglycerides - Ratio to Baseline

    Time frame · Baseline (week 0), (week 34)

    Registry description

    Change from baseline (week 0) to week 34 in triglycerides measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.

  11. Relative Change From Baseline in Free Fatty Acids - Ratio to Baseline

    Time frame · Baseline (week 0), (week 34)

    Registry description

    Change in baseline (week 0) to week 34 in free fatty acids measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.

  12. Relative Change From Baseline in Apolipoprotein B (ApoB) - Ratio to Baseline

    Time frame · Baseline (week 0), (week 34)

    Registry description

    Change from baseline (week 0) to week 34 in ApoB measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.

  13. Relative Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline

    Time frame · Baseline (week 0), (week 34)

    Registry description

    Change from baseline (week 0) to week 34 in hsCRP measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.

  14. Number of Treatment-Emergent Adverse Events (TEAEs)

    Time frame · Baseline (week 0) to (week 39)

    Registry description

    An adverse event (AE) defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of an investigational medicinal product (IMP). All AEs mentioned are treatment emergent adverse events (TEAE) defined as an event with onset during the on treatment period. On treatment period: the time period where all observed data for which subjects are considered exposed to randomised treatment.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Secondary and other outcome results(8)
Secondary outcomeMean· Baseline (week 0), (week 34)

Change From Baseline in Fasting Plasma Glucose (FPG)

GroupValue (millimoles per litre (mmol/L))Spread
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg-3.92.6
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg-3.42.1
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg-3.82.4
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg-3.82.9
Semaglutide 2.4 mg + Placebo (NNC0480-0389)-3.61.8
NNC0480-0389 21.6 mg + Placebo (Semaglutide)-1.42.8
Placebo-0.13.2
Secondary outcomeMean· Baseline (week 0), (week 34)

Change From Baseline in Body Weight (Kilogram [kg])

GroupValue (Kilogram (kg))Spread
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg-8.95.8
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg-127.7
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg-105.9
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg-125.4
Semaglutide 2.4 mg + Placebo (NNC0480-0389)-9.85.8
NNC0480-0389 21.6 mg + Placebo (Semaglutide)-4.75.1
Placebo-2.63.9
Secondary outcomeMean· Baseline (week 0), (week 34)

Percent Change From Baseline in Body Weight

GroupValue (Percent Change of body weight)Spread
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg-9.35.8
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg-137.3
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg-115.8
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg-135.4
Semaglutide 2.4 mg + Placebo (NNC0480-0389)-106.3
NNC0480-0389 21.6 mg + Placebo (Semaglutide)-4.34.5
Placebo-2.74.1
Secondary outcomeMean· Baseline (week 0), (week 34)

Change From Baseline in Waist Circumference

GroupValue (Centimeter (cm))Spread
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg-85
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg-117
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg-97
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg-107
Semaglutide 2.4 mg + Placebo (NNC0480-0389)-86
NNC0480-0389 21.6 mg + Placebo (Semaglutide)-55
Placebo-35
Secondary outcomeMean· Baseline (week 0), (week 34)

Change From Baseline in Systolic Blood Pressure (SBP)

GroupValue (Millimeters of mercury (mmHg))Spread
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg-612
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg-1014
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg-913
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg-1312
Semaglutide 2.4 mg + Placebo (NNC0480-0389)-516
NNC0480-0389 21.6 mg + Placebo (Semaglutide)-312
Placebo08
Secondary outcomeGeometric mean· Baseline (week 0), (week 34)

Relative Change From Baseline in Total Cholesterol - Ratio to Baseline

GroupValue (Ratio of total cholesterol)Spread
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg0.9419.7
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg0.8922.7
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg0.9021.7
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg0.9017.3
Semaglutide 2.4 mg + Placebo (NNC0480-0389)0.9318.2
NNC0480-0389 21.6 mg + Placebo (Semaglutide)1.0022.9
Placebo0.9616.2
Secondary outcomeGeometric mean· Baseline (week 0), (week 34)

Relative Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline

GroupValue (Ratio of HDL cholesterol)Spread
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg1.0517.6
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg1.0619.8
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg1.0716.7
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg1.0016.0
Semaglutide 2.4 mg + Placebo (NNC0480-0389)1.0415.6
NNC0480-0389 21.6 mg + Placebo (Semaglutide)1.0416.2
Placebo1.0417.0
Secondary outcomeGeometric mean· Baseline (week 0), (week 34)

Relative Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline

GroupValue (Ratio of LDL cholesterol)Spread
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg0.9528.4
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg0.8546.5
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg0.9137.5
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg0.8836.0
Semaglutide 2.4 mg + Placebo (NNC0480-0389)0.9532.2
NNC0480-0389 21.6 mg + Placebo (Semaglutide)0.9653.5
Placebo0.9629.8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Semaglutide 2.4 mg + NNC0480-0389 2.4 mgParticipants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).0 / 776 / 7740 / 77
Semaglutide 2.4 mg + NNC0480-0389 7.2 mgParticipants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).0 / 743 / 7444 / 74
Semaglutide 2.4 mg + NNC0480-0389 12.0 mgParticipants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).0 / 772 / 7736 / 77
Semaglutide 2.4 mg + NNC0480-0389 21.6 mgParticipants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).0 / 775 / 7737 / 77
Semaglutide 2.4 mg + Placebo (NNC0480-0389)Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.0 / 753 / 7534 / 75
NNC0480-0389 21.6 mg + Placebo (Semaglutide)Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.0 / 592 / 5925 / 59
PlaceboParticipants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.0 / 612 / 6123 / 61

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening * Participants treated with diet and exercise as monotherapy or in combination with stable daily dose(s) greater than or equal to 90 days before screening of any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose * HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) * BMI greater than or equal to 25 and below 40 kg/m\^2 Exclusion Criteria: * Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 days and prior insulin treatment for gestational diabetes are allowed * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before 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 * Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with T2D)

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