Safety Study of Weekly Semaglutide in Chilean Participants With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Safety and Tolerability of Weekly Semaglutide 0.5 mg or 1.0 mg in Chilean Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05533632
• Other study ID #: NN9535-4844
• Secondary ID: U1111-1281-5677
• Status: Completed
• Phase: Phase 4
• Start date: March 29, 2022
• Est. completion date: January 18, 2024

Study information

• Verified date: March 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is testing the safety and tolerability of subcutaneous semaglutide in participants with type 2 diabetes (T2D) in Chile. Participants will get a once-weekly subcutaneous injection of semaglutide in doses decided by the study doctor's criteria, according to participant's personal needs. The study will last for about 24 weeks. Participants will have 4 clinic visits and 2 phone calls. Participants will have 3 laboratory tests during the study (blood and urine samples).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 18, 2024
• Est. primary completion date: January 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants diagnosed (clinically) with type 2 diabetes greater than equal to (=) 90 days prior to the screening visit.

• Stable daily dose of Oral Antidiabetic Drug (OAD) and/or insulin treatment for = 60 days prior to the screening visit.

• HbA1c 7.5-10% (59-86 millimoles per mole [mmol/mol]) (both inclusive) in Visit 1.

• Participants in which Ozempic is indicated according to approved local label.

• Fundoscopy/Fundus photography record less than equal to (=) 12 months.

Exclusion Criteria:

• Known or suspected hypersensitivity to study intervention(s) or related products.

• Previous participation in this study. Participation is defined as signed informed consent.

• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.

• Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before the screening visit, except Coronavirus Disease 2019 (COVID-19) related trials (this is allowed).

• Treatment with any glucagon-like peptide-1 receptor agonists (GLP-1 RA) medication prior to the screening visit.

• Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

• Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma.

• History of pancreatitis (acute or chronic).

• Renal impairment defined as estimated glomerular filtration rate (eGFR) below 30 milliliters/minute (mL/min)/1.73 meter square (m^2) as per MDRD-4 (Modification of Diet in Renal Disease).

• Myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening.

• Participants presently classified as being in New York Heart Association (NYHA) Class IV heart failure.

• Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.

• Participants with alanine aminotransferase (ALT) > 2.5 x upper normal limit (UNL).

• Use of systemic immunosuppressive treatment within 90 days prior to screening.

• Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening. An exception is short-term insulin treatment for acute illness for a total of = 14 days.

• Known hypoglycaemic unawareness and/or recurrent severe hypoglycaemic episodes as judged by the investigator.

• Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 12 months prior to screening.

• History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Semaglutide
Participants will receive semaglutide s.c. injection once weekly in a dose escalation manner for 24 weeks.

Locations

Country	Name	City	State
Chile	Hospital Padre Hurtado	Santiago, Región Metropolitana
Chile	Hospital San Juan de Dios_Santiago, Región Metropolitana	Santiago, Región Metropolitana
Chile	Servicios Médicos Godoy Limitada	Santiago, Región Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events	An adverse event is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study drug, whether or not considered related to the study drug. Measured as number of events.	From baseline to week 24
Secondary	Change in Glycosylated Haemoglobin (HbA1c)	Measured as percentage (%).	From baseline to week 24
Secondary	Participants Achieving HbA1c Less Than 7.0 Percentage	Measured as yes/no.	From baseline to week 24
Secondary	Change of Fasting Plasma Glucose (FPG)	Measured as milligrams per deciliter (mg/dL).	From baseline to week 24
Secondary	Change of Body Weight	Measured as kilograms (kg).	From baseline to week 24
Secondary	Change of Waist Circumference	Measured as centimeters (cm).	From baseline to week 24
Secondary	Participants Achieving Greater Than Equal To (=) 5% And = 10% Weight Reduction	Measured as yes/no.	From baseline to week 24
Secondary	Change in Laboratory Tests	Measured as lab test unit correspondent.	From baseline to week 24
Secondary	Participants Discontinued Due to Adverse Events (Treatment Discontinuation)	Measured as yes/no.	From baseline to week 24
Secondary	Number of Severe Hypoglycaemic Episodes Per Participant	Measured as number of episodes	From baseline to week 24
Secondary	Number of Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes Per Participant	Measured as number of episodes	From baseline to week 24
Secondary	Number of Serious Adverse Events (SAEs) Per Participant	An SAE is any untoward medical occurrence that fulfils at least one of the following criteria: results in death; is life-threatening; requires inpatient hospitalisation or prolongation of existing hospitalisation; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; important medical event. Measured as number of events.	From baseline to week 24
Secondary	Number of Adverse Reactions (ARs) Per Participant	Measured as number of events	From baseline to week 24
Secondary	Number of Serious Adverse Reactions (SARs) Per Participant	Measured as number of events	From baseline to week 24
Secondary	Number of Suspected Unexpected Serious Adverse Reactions (SUSARs) Per Participant	Measured as number of events	From baseline to week 24
Secondary	Change From Baseline in Heart Rate (Pulse) After 24 Weeks of Treatment	Measured as beats per minute (bpm).	From baseline to week 24