Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
10 – 18
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
Novo Nordisk A/S · Industry
Who this trial is looking for
This trial is looking for children and teenagers with type 2 diabetes. Participants will receive either a new medicine called CagriSema or a placebo for part of the study, and then everyone will receive CagriSema for the second part.
Are You a Good Fit for This Trial?
Must be takingDiet and exerciseMetforminInsulin
You may be able to join if
I am aged 10 to 17 years old.
I have been diagnosed with type 2 diabetes for at least 30 days.
I weigh at least 45 kg.
I have an HbA1c level of 6.5% to 11.0%.
I have consent from my parent or legal representative.
I can give assent if I am age-appropriate.
You may not be able to join if
I am female and pregnant or breastfeeding.
I have taken any other diabetes or weight loss medications in the last 90 days.
I have had severe low blood sugar episodes in the last year.
I have known hypoglycemic unawareness.
I have uncontrolled diabetic retinopathy.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this clinical study is to look into how well a study medicine called CagriSema helps children and adolescents living with diabetes lower their blood sugar and body weight. The study has 2 parts: in the first part participant will get either CagriSema or placebo, and in the second part participant will get CagriSema. In the first part, which treatment participant gets is decided by c…
The purpose of this clinical study is to look into how well a study medicine called CagriSema helps children and adolescents living with diabetes lower their blood sugar and body weight. The study has 2 parts: in the first part participant will get either CagriSema or placebo, and in the second part participant will get CagriSema. In the first part, which treatment participant gets is decided by chance and second part is open label and all participants will get CagriSema during this part. The study will last for about 1 year and 3 months.
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
* Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including acti…
Key Inclusion Criteria:
* Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
* The parent(s) or LAR of the child must sign and date the Informed Consent Form (according to local requirements)
* The child must sign and date the Child Assent Form or provide oral assent (according to local requirements)
* Male or female.
* Age 10 to \< 18 years at the time of signing the informed consent.
* Diagnosed with T2D (according to the latest International Society for Pediatric and Adolescent Diabetes \[ISPAD\] criteria) ≥ 30 days before screening.
* Treated with diet and exercise counselling alone or with a stable daily dose(a), in addition to diet and exercise counselling, of any of the following antidiabetic drugs or combination regimens:
* Insulin (any regimen)
* Metformin
* SGLT2i
* HbA1c 6.5%-11.0% (48 mmol/mol - 97 mmol/mol) (both inclusive) as determined by central laboratory at screening.
* Body weight ≥ 45 kg and BMI ≥ 85th percentile(b). BMI will be calculated in the electronic case report form based on height and body weight at screening.
* (a) For metformin, a stable dose is defined as at least 1000 mg daily or the maximum tolerated dose for ≥ 56 days prior to screening. For Sodium-Glucose Transport protein 2 inhibitor (SGLT2i), a stable dose is defined as the same total daily dose for ≥ 56 days prior to screening. For insulin, it is defined as the dose ± 25% of that taken at screening for ≥ 30 days prior to screening.
* (b) Based on sex-specific BMI-for-age percentiles for the given country or region. If not available for the country or region, the respective charts or tables on cdc.gov may be used.
Key Exclusion Criteria:
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
* Treatment with any antidiabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening.
* Known or previous diagnosis of hypoparathyroidism.
* Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed \>1 year before screening, (2) lap banding, if the band has been removed \>1 year before screening, (3) intragastric balloon, if the balloon has been removed \>1 year before screening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed \> 1 year before screening.
* Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies as determined by central laboratory at screening or in medical history.
* Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
* Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8.
* Uncontrolled and potentially unstable diabetic retinopathy maculopathy. Verified by a fundus examination and optical coherence tomography (OCT) assessment 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.
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