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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06326047




Registration number
NCT06326047
Ethics application status
Date submitted
16/03/2024
Date registered
22/03/2024

Titles & IDs
Public title
A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Lower Blood Sugar in People With Type 2 Diabetes
Scientific title
Investigation of the Safety and Efficacy of Once Weekly NNC0519-0130 in Participants With Type 2 Diabetes - a Dose Finding Study
Secondary ID [1] 0 0
U1111-1291-9196
Secondary ID [2] 0 0
NN9541-4945
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NNC0519-0130
Treatment: Drugs - Placebo
Treatment: Drugs - Trizepatide

Experimental: Dosing scheme A (NNC0519-0130) - Participants will receive NNC0519-0130 at 3 dose levels once weekly (QW) as subcutaneous (s.c.) injection in dose escalating manner.

Placebo comparator: Dosing scheme A (Placebo) - Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.

Experimental: Dosing scheme B (NNC0519-0130) - Participants will receive NNC0519-0130 at 3 dose levels once weekly (QW) as s.c. injection in dose escalating manner.

Placebo comparator: Dosing scheme B (Placebo) - Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.

Experimental: Dosing scheme C (NNC0519-0130) - Participants will receive NNC0519-0130 at 5 dose levels once weekly as s.c. injection in dose escalating manner.

Placebo comparator: Dosing scheme C (Placebo) - Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.

Experimental: Dosing scheme D (NNC0519-0130) - Participants will receive NNC0519-0130 at 5 dose levels once weekly as s.c. injection in dose escalating manner.

Placebo comparator: Dosing scheme D (Placebo) - Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.

Experimental: Dosing scheme E (NNC0519-0130) - Participants will receive NNC0519-0130 at 7 dose levels once weekly as s.c. injection in dose escalating manner.

Placebo comparator: Dosing scheme E (Placebo) - Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.

Active comparator: Dosing scheme F (tirzepatide) - Participants will receive tirzepatide at 6 dose levels once weekly as s.c. injection in dose escalating manner.


Treatment: Drugs: NNC0519-0130
NNC0519-0130 will be administered subcutaneously.

Treatment: Drugs: Placebo
Placebo will be administered subcutaneously.

Treatment: Drugs: Trizepatide
Trizepatide will be administered subcutaneously.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Glycated haemoglobin (HbA1c)
Timepoint [1] 0 0
From baseline (week 0) to 12 weeks on a given maintenance dose
Secondary outcome [1] 0 0
Change in Glycated haemoglobin (HbA1c)
Timepoint [1] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [2] 0 0
Relative change in body weight
Timepoint [2] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [3] 0 0
Change in body weight
Timepoint [3] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [4] 0 0
Change in fasting plasma glucose (FPG)
Timepoint [4] 0 0
From baseline (week 0) to 12 weeks on a given maintenance dose
Secondary outcome [5] 0 0
Continuous glucose monitoring (CGM): Change in time in range (TIR) 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL))
Timepoint [5] 0 0
From baseline (week -2 to week 0) to week 22-24 and week 34-36, respectively
Secondary outcome [6] 0 0
Change in waist circumference
Timepoint [6] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [7] 0 0
Change in systolic blood pressure (SBP)
Timepoint [7] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [8] 0 0
Change in high sensitivity C-Reactive Protein (hsCRP)
Timepoint [8] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [9] 0 0
Change in total cholesterol
Timepoint [9] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [10] 0 0
Change in high-density lipoprotein (HDL) cholesterol
Timepoint [10] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [11] 0 0
Change in low-density lipoprotein (LDL) cholesterol
Timepoint [11] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [12] 0 0
Change in triglycerides
Timepoint [12] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [13] 0 0
Number of adverse events
Timepoint [13] 0 0
From baseline (week 0) to end of study (week 40)

Eligibility
Key inclusion criteria
* Female of non-childbearing potential, or male.
* For United States (US) only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency and willingness to continue using it through-out the study or male.
* Age 18-75 years (both inclusive) at the time of signing the informed consent.
* Diagnosed with type 2 diabetes mellitus greater than or equal 180 days before screening.
* Stable daily dose(s) more than or equal 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without sodium-glucose co-transporter 2 (SGLT2) inhibitor.
* Glycated haemoglobin (HbA1c) of 7.5-10.0% (58-86 millimoles per moles (mmol/mol)) (both inclusive) as assessed by central laboratory at screening.
* Body mass index (BMI) greater than or equal 23.0 kilograms per meter square (kg/m^2).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 consecutive 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.
* Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/10/2025
Actual
Sample size
Target
288
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Macquarie University - Macquarie Park
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 0 0
Roger Chih Yu Chen - Sydney
Recruitment hospital [4] 0 0
Western Endocrine Blacktown - Sydney
Recruitment hospital [5] 0 0
Illawarra Diabetes Service Clinical Trials & Research Unit - Wollongong
Recruitment hospital [6] 0 0
University of Sunshine Coast - Birtinya
Recruitment hospital [7] 0 0
Eastern Clinical Research Unit Box Hill - Box Hill
Recruitment hospital [8] 0 0
Emeritus Research Melbourne - Camberwell
Recruitment hospital [9] 0 0
Austin Health, Metabolic Disorders Centre - Heidelberg Heights
Recruitment hospital [10] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
2148 - Sydney
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
4575 - Birtinya
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3124 - Camberwell
Recruitment postcode(s) [8] 0 0
3081 - Heidelberg Heights
Recruitment postcode(s) [9] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Montana
Country [10] 0 0
United States of America
State/province [10] 0 0
Nevada
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
Canada
State/province [17] 0 0
British Columbia
Country [18] 0 0
Canada
State/province [18] 0 0
New Brunswick
Country [19] 0 0
Canada
State/province [19] 0 0
Nova Scotia
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
India
State/province [22] 0 0
Karnataka
Country [23] 0 0
India
State/province [23] 0 0
Kerala
Country [24] 0 0
India
State/province [24] 0 0
Madhya Pradesh
Country [25] 0 0
India
State/province [25] 0 0
Maharashtra
Country [26] 0 0
India
State/province [26] 0 0
Rajasthan
Country [27] 0 0
India
State/province [27] 0 0
Tamil Nadu
Country [28] 0 0
India
State/province [28] 0 0
Telangana
Country [29] 0 0
India
State/province [29] 0 0
Bengaluru
Country [30] 0 0
Japan
State/province [30] 0 0
Chiba
Country [31] 0 0
Japan
State/province [31] 0 0
Soka-shi, Saitama
Country [32] 0 0
Japan
State/province [32] 0 0
Tokyo
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Gyeonggi-do
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Seoul
Country [35] 0 0
South Africa
State/province [35] 0 0
Free State
Country [36] 0 0
South Africa
State/province [36] 0 0
Gauteng
Country [37] 0 0
South Africa
State/province [37] 0 0
KwaZulu-Natal

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Transparency (dept. 2834)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novo Nordisk
Address 0 0
Country 0 0
Phone 0 0
(+1) 866-867-7178
Fax 0 0
Email 0 0
clinicaltrials@novonordisk.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://novonordisk-trials.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06326047