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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
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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