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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06065540




Registration number
NCT06065540
Ethics application status
Date submitted
26/09/2023
Date registered
4/10/2023

Titles & IDs
Public title
A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor
Scientific title
Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. in Doses 2.4/2.4 mg and 1.0/1.0 mg Once Weekly Versus Semaglutide 2.4 mg and 1.0 mg, Cagrilintide 2.4 mg and Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Metformin With or Without an SGLT2 Inhibitor
Secondary ID [1] 0 0
U1111-1283-0427
Secondary ID [2] 0 0
NN9388-4896
Universal Trial Number (UTN)
Trial acronym
REIMAGINE 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 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 - Cagrilintide
Treatment: Drugs - Semaglutide
Treatment: Drugs - Placebo cagrilintide
Treatment: Drugs - Placebo semaglutide

Experimental: CagriSema 2.4 mg/2.4 mg - Participants will receive once-weekly subcutaneous (s.c) injections of 2.4 mg cagrilintide and 2.4 mg semaglutide for 68 weeks.

Experimental: CagriSema 1.0 mg/1.0 mg - Participants will receive once-weekly s.c injections of 1.0 mg cagrilintide and 1.0 mg semaglutide for 68 weeks.

Active comparator: Semaglutide 2.4 mg - Participants will receive once-weekly s.c injection of 2.4 mg semaglutide for 68 weeks.

Active comparator: Semaglutide 1.0 mg - Participants will receive once-weekly s.c injection of 1.0 mg semaglutide for 68 weeks.

Active comparator: Cagrilintide 2.4 mg - Participants will receive once-weekly s.c injection of 2.4 mg cagrilintide for 68 weeks.

Placebo comparator: Placebo 2.4 mg/2.4 mg - Participants will receive once-weekly s.c injection of placebo matched to 2.4 mg cagrilintide and 2.4 mg semaglutide for 68 weeks.

Placebo comparator: Placebo 1.0 mg/1.0 mg - Participants will receive once-weekly s.c injection of placebo matched to 1.0 mg cagrilintide and 1.0 mg semaglutide for 68 weeks.


Treatment: Drugs: Cagrilintide
Participants will receive once-weekly s.c injection of cagrilintide at escalating doses every week until maintenance dose of 2.4 mg and 1.0 mg of cagrilintide is reached.

Treatment: Drugs: Semaglutide
Participants will receive once-weekly s.c injection of semaglutide at escalating doses every week until maintenance dose of 2.4 mg and 1.0 mg of semaglutide is reached.

Treatment: Drugs: Placebo cagrilintide
Participants will receive placebo matched to cagrilintide subcutaneously.

Treatment: Drugs: Placebo semaglutide
Participants will receive placebo matched to semaglutide subcutaneously.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg versus 1.0 mg): Change in glycated haemoglobin (HbA1c)
Timepoint [1] 0 0
From baseline (week 0) to end of treatment (week 68)
Primary outcome [2] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg versus 1.0 mg): Relative change in body weight
Timepoint [2] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [1] 0 0
CagriSema 2.4 mg/2.4 mg versus cagrilintide 2.4 mg: Change in HbA1c
Timepoint [1] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [2] 0 0
CagriSema 2.4 mg/2.4 mg versus cagrilintide 2.4 mg: Relative change in body weight
Timepoint [2] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [3] 0 0
CagriSema 2.4 mg/2.4 mg versus semaglutide 1.0 mg: Change in HbA1c
Timepoint [3] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [4] 0 0
CagriSema 2.4 mg/2.4 mg versus semaglutide 1.0 mg: Relative change in body weight
Timepoint [4] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [5] 0 0
Cagrilintide 2.4 mg versus placebo: Change in HbA1c
Timepoint [5] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [6] 0 0
Cagrilintide 2.4 mg versus placebo: Relative change in body weight
Timepoint [6] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [7] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Achievement of greater than or equal to (>=) 10 percent (%) weight reduction
Timepoint [7] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [8] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Achievement of >= 15 % weight reduction
Timepoint [8] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [9] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Achievement of >= 20 % weight reduction
Timepoint [9] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [10] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): CGM - Change in time in Tight Target Range (TITR) 3.9-7.8 millimoles per litre (mmol/L) (70-140 milligrams per decilitre [mg/dL])
Timepoint [10] 0 0
From baseline (week -3) to end of treatment (week 68)
Secondary outcome [11] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Change in Systolic Blood Pressure (SBP)
Timepoint [11] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [12] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in triglycerides
Timepoint [12] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [13] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in non-High Density Lipoprotein (HDL) cholesterols
Timepoint [13] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [14] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): CGM - Change in Time In Range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL)
Timepoint [14] 0 0
From baseline (week -3) to end of treatment (week 68)
Secondary outcome [15] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in high sensitivity C-Reactive Protein (hsCRP)
Timepoint [15] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [16] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Change in Fasting Plasma Glucose (FPG)
Timepoint [16] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [17] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Achievement of HbA1c target values of less than (<) 7.0% (<53 millimoles per mole [mmol/mol])
Timepoint [17] 0 0
At end of treatment (week 68)
Secondary outcome [18] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Achievement of HbA1c target values of less than or equal to (=)6.5% (=48 mmol/mol)
Timepoint [18] 0 0
At end of treatment (week 68)
Secondary outcome [19] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): CGM - Change in time above range, >10.0 mmol/L (>180 mg/dL)
Timepoint [19] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [20] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): CGM - Change in time above range, >13.9 mmol/L (>250 mg/dL)
Timepoint [20] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [21] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): CGM - Within-day glycaemic variability (% coefficient of variation [CV])
Timepoint [21] 0 0
At end of treatment (week 68)
Secondary outcome [22] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg versus 1.0 mg): Achievement of = 5 % weight reduction
Timepoint [22] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [23] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Change in waist circumference
Timepoint [23] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [24] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Change in Diastolic Blood Pressure (DBP)
Timepoint [24] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [25] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in total cholesterol
Timepoint [25] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [26] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in HDL cholesterol
Timepoint [26] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [27] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in low-density lipoprotein (LDL) cholesterol
Timepoint [27] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [28] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in very low-density lipoprotein (VLDL) cholesterol
Timepoint [28] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [29] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in free fatty acids
Timepoint [29] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [30] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Change in Short Form (SF)-36v score- Physical component summary score
Timepoint [30] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [31] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Change in SF-36v2 score- Mental component summary score
Timepoint [31] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [32] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score
Timepoint [32] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [33] 0 0
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Change in Treatment Related Impact Measure for Diabetes (TRIM-D) score
Timepoint [33] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [34] 0 0
CagriSema (2.4 mg/2.4 mg and 1.0 mg/1.0 mg) versus semaglutide (2.4 mg and 1.0 mg), placebo and cagrilintide 2.4 mg: Number of treatment emergent adverse events (TEAEs)
Timepoint [34] 0 0
From baseline (week 0) to end of study (week 75)
Secondary outcome [35] 0 0
CagriSema (2.4 mg/2.4 mg and 1.0 mg/1.0 mg) versus semaglutide (2.4 mg and 1.0 mg), placebo and cagrilintide 2.4 mg: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter)
Timepoint [35] 0 0
From baseline (week 0) to end of study (week 75)
Secondary outcome [36] 0 0
CagriSema (2.4 mg/2.4 mg and 1.0 mg/1.0 mg) versus semaglutide (2.4 mg and 1.0 mg), placebo and cagrilintide 2.4 mg: Number of severe hypoglycaemic episodes (level 3)
Timepoint [36] 0 0
From baseline (week 0) to end of study (week 75)

Eligibility
Key inclusion criteria
* Male or female.
* Age 18 years or above at the time of signing the informed consent.
* Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening.
* Stable daily dose(s) greater than or equal to 90 days before screening of any 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 Cotransporter-2 (SGLT2) inhibitors.
* Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mole [mmol/mol]) (both inclusive) as determined by central laboratory at screening.
* Body Mass Index (BMI) greater than or equal to 25 kilogram per square metre ( kg/m^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square metre (mL/min/1.73 m^2) as determined by central laboratory at screening.
* 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.

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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/01/2026
Actual
Sample size
Target
2700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Clinical Research Facility, Charles Perkins Centre - Camperdown
Recruitment hospital [2] 0 0
Holdsworth House Clinical Research - Darlinghurst
Recruitment hospital [3] 0 0
Macquarie University - Macquarie Park
Recruitment hospital [4] 0 0
Hunter Diabetes Centre - Merewether
Recruitment hospital [5] 0 0
Logan Hospital - Meadowbrook
Recruitment hospital [6] 0 0
Southern Adelaide Diabetes & Endocrine Services - Oaklands Park
Recruitment hospital [7] 0 0
St Vincent's Hospital - Melbourne - Fitzroy
Recruitment hospital [8] 0 0
Baker IDI Heart and Diabetes Institute - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [4] 0 0
2291 - Merewether
Recruitment postcode(s) [5] 0 0
4131 - Meadowbrook
Recruitment postcode(s) [6] 0 0
5046 - Oaklands Park
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment outside Australia
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Lübeck
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München
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Attica
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State/province [95] 0 0
Budapest
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Hungary
State/province [96] 0 0
Kaposvár
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Hungary
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Szombathely
Country [98] 0 0
India
State/province [98] 0 0
Andhra Pradesh
Country [99] 0 0
India
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Assam
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India
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Karnataka
Country [101] 0 0
India
State/province [101] 0 0
Maharashtra
Country [102] 0 0
India
State/province [102] 0 0
Rajasthan
Country [103] 0 0
India
State/province [103] 0 0
Tamil Nadu
Country [104] 0 0
India
State/province [104] 0 0
Telangana
Country [105] 0 0
India
State/province [105] 0 0
West Bengal
Country [106] 0 0
India
State/province [106] 0 0
Ahmedabad
Country [107] 0 0
India
State/province [107] 0 0
Chandigarh
Country [108] 0 0
India
State/province [108] 0 0
New Delhi
Country [109] 0 0
Israel
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Haifa
Country [110] 0 0
Israel
State/province [110] 0 0
Herzlia
Country [111] 0 0
Israel
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Holon
Country [112] 0 0
Israel
State/province [112] 0 0
Jerusalem
Country [113] 0 0
Israel
State/province [113] 0 0
Rehovot
Country [114] 0 0
Israel
State/province [114] 0 0
Tel Hashomer
Country [115] 0 0
Italy
State/province [115] 0 0
Fi
Country [116] 0 0
Italy
State/province [116] 0 0
MI
Country [117] 0 0
Italy
State/province [117] 0 0
Arezzo
Country [118] 0 0
Italy
State/province [118] 0 0
Bergamo
Country [119] 0 0
Italy
State/province [119] 0 0
Catanzaro
Country [120] 0 0
Italy
State/province [120] 0 0
Chieti Scalo
Country [121] 0 0
Italy
State/province [121] 0 0
Milano
Country [122] 0 0
Italy
State/province [122] 0 0
Napoli
Country [123] 0 0
Italy
State/province [123] 0 0
Palermo
Country [124] 0 0
Italy
State/province [124] 0 0
Roma
Country [125] 0 0
Italy
State/province [125] 0 0
Rome
Country [126] 0 0
Japan
State/province [126] 0 0
Fukushima, Japan
Country [127] 0 0
Japan
State/province [127] 0 0
Oita, Japan
Country [128] 0 0
Japan
State/province [128] 0 0
Chiba-shi, Chiba
Country [129] 0 0
Japan
State/province [129] 0 0
Ibaraki
Country [130] 0 0
Japan
State/province [130] 0 0
Mito-shi, Ibaraki
Country [131] 0 0
Japan
State/province [131] 0 0
Osaka-shi, Osaka
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Japan
State/province [132] 0 0
Tokyo
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Daegu
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Seoul
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Mexico
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Baja California
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Mexico
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Jalisco
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Poland
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Lodzkie
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Poland
State/province [140] 0 0
Lubuskie
Country [141] 0 0
Poland
State/province [141] 0 0
Malopolskie
Country [142] 0 0
Poland
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Mazovian Voivodeship
Country [143] 0 0
Poland
State/province [143] 0 0
Podkarpackie
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Poland
State/province [144] 0 0
Podlaskie
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Poland
State/province [145] 0 0
Slaskie
Country [146] 0 0
Poland
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Lublin
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Poland
State/province [147] 0 0
Pulawy
Country [148] 0 0
Poland
State/province [148] 0 0
Staszow
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Poland
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Warszawa
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Romania
State/province [150] 0 0
Bucurestii
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Romania
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Cluj
Country [152] 0 0
Romania
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Prahova
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Romania
State/province [153] 0 0
Salaj
Country [154] 0 0
Romania
State/province [154] 0 0
Bacau
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Romania
State/province [155] 0 0
Brasov
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Romania
State/province [156] 0 0
Bucuresti
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Romania
State/province [157] 0 0
Craiova
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Romania
State/province [158] 0 0
Galati
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Romania
State/province [159] 0 0
Pascani
Country [160] 0 0
Romania
State/province [160] 0 0
Reghin
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Serbia
State/province [161] 0 0
Vojvodina
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Serbia
State/province [162] 0 0
Belgrade
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Serbia
State/province [163] 0 0
Kragujevac
Country [164] 0 0
Slovakia
State/province [164] 0 0
Bardejov
Country [165] 0 0
Slovakia
State/province [165] 0 0
Kosice
Country [166] 0 0
Slovakia
State/province [166] 0 0
Malacky
Country [167] 0 0
Slovakia
State/province [167] 0 0
Presov
Country [168] 0 0
Slovakia
State/province [168] 0 0
Prievidza
Country [169] 0 0
Slovakia
State/province [169] 0 0
Ruzomberok
Country [170] 0 0
Slovakia
State/province [170] 0 0
Sabinov
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Slovakia
State/province [171] 0 0
Surany
Country [172] 0 0
Slovakia
State/province [172] 0 0
Trebisov
Country [173] 0 0
Slovakia
State/province [173] 0 0
Ziar nad Hronom
Country [174] 0 0
Slovenia
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Kocevje
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Slovenia
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Koper
Country [176] 0 0
Slovenia
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Ljubljana
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Slovenia
State/province [177] 0 0
Maribor
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Slovenia
State/province [178] 0 0
Nova Gorica
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Slovenia
State/province [179] 0 0
Topolšica
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South Africa
State/province [180] 0 0
Eastern Cape
Country [181] 0 0
South Africa
State/province [181] 0 0
Gauteng
Country [182] 0 0
South Africa
State/province [182] 0 0
Western Cape
Country [183] 0 0
Spain
State/province [183] 0 0
Barcelona
Country [184] 0 0
Spain
State/province [184] 0 0
La Coruña
Country [185] 0 0
Spain
State/province [185] 0 0
La Roca del Vallés
Country [186] 0 0
Spain
State/province [186] 0 0
Móstoles
Country [187] 0 0
Spain
State/province [187] 0 0
Palma de Mallorca
Country [188] 0 0
Spain
State/province [188] 0 0
Segovia
Country [189] 0 0
Spain
State/province [189] 0 0
Sevilla
Country [190] 0 0
Spain
State/province [190] 0 0
Valencia
Country [191] 0 0
Sweden
State/province [191] 0 0
Lund
Country [192] 0 0
Sweden
State/province [192] 0 0
Malmö
Country [193] 0 0
Sweden
State/province [193] 0 0
Mölndal
Country [194] 0 0
Sweden
State/province [194] 0 0
Stockholm
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Sweden
State/province [195] 0 0
Örebro
Country [196] 0 0
Taiwan
State/province [196] 0 0
Changhua City
Country [197] 0 0
Taiwan
State/province [197] 0 0
Taipei city
Country [198] 0 0
Turkey
State/province [198] 0 0
Adana
Country [199] 0 0
Turkey
State/province [199] 0 0
Antalya
Country [200] 0 0
Turkey
State/province [200] 0 0
Eskisehir
Country [201] 0 0
Turkey
State/province [201] 0 0
Istanbul
Country [202] 0 0
Turkey
State/province [202] 0 0
Rize
Country [203] 0 0
Turkey
State/province [203] 0 0
Tekirdag
Country [204] 0 0
United Kingdom
State/province [204] 0 0
Hertfordshire
Country [205] 0 0
United Kingdom
State/province [205] 0 0
Aberdeen
Country [206] 0 0
United Kingdom
State/province [206] 0 0
Bath
Country [207] 0 0
United Kingdom
State/province [207] 0 0
Blackburn
Country [208] 0 0
United Kingdom
State/province [208] 0 0
Dundee
Country [209] 0 0
United Kingdom
State/province [209] 0 0
Foresterhill
Country [210] 0 0
United Kingdom
State/province [210] 0 0
Liverpool
Country [211] 0 0
United Kingdom
State/province [211] 0 0
Norwich
Country [212] 0 0
United Kingdom
State/province [212] 0 0
Pickering
Country [213] 0 0
United Kingdom
State/province [213] 0 0
Southampton
Country [214] 0 0
United Kingdom
State/province [214] 0 0
Swansea
Country [215] 0 0
United Kingdom
State/province [215] 0 0
Truro

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
[email protected]
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/NCT06065540