Clinical trial NCT05533632: Safety Study of Weekly Semaglutide in Chilean Participants With Type 2 Diabetes
Official title: Safety and Tolerability of Weekly Semaglutide 0.5 mg or 1.0 mg in Chilean Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-09-09
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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).

Primary outcomes:
measure: Number of Adverse Events (AEs)
timeFrame: From baseline (Day 1) up to 24 weeks
Secondary outcomes:
measure: Change in Glycosylated Haemoglobin (HbA1c)
timeFrame: Baseline (week 1), week 24
measure: Participants Achieving HbA1c Less Than (<) 7.0 Percentage (%) [Yes/No]
timeFrame: From baseline (week 1) to week 24
measure: Change in Fasting Plasma Glucose (FPG) [Milligrams Per Decilitre (mg/dL)]
timeFrame: Baseline (week 1), week 24
measure: Change in Body Weight (Kilogram [Kg])
timeFrame: Baseline (week 1), week 24
measure: Change in Waist Circumference [Centimeter (cm)]
timeFrame: Baseline (week 1), week 24
measure: Participants Achieving Greater Than or Equal (≥) 5% Weight Reduction (Yes/No)
timeFrame: From baseline (week 1) to week 24
measure: Participants Achieving Greater Than or Equal (≥) 10% Weight Reduction (Yes/No)
timeFrame: From baseline (week 1) to week 24
measure: Change in Total Cholesterol (mg/dL)
timeFrame: Baseline (week 1), week 24
measure: Change in Low Density Lipoprotein (LDL) Cholesterol (mg/dL)
timeFrame: Baseline (week 1), week 24
measure: Change in High Density Lipoprotein (HDL) Cholesterol (mg/dL)
timeFrame: Baseline (week 1), week 24
measure: Change in Triglycerides (mg/dL)
timeFrame: Baseline (week 1), week 24
measure: Change in Estimated Glomerular Filtration Rate (eGFR) [Millilitre Per Minute (mL/Min) Per 1.73 Square Meter (m^2)]
timeFrame: Baseline (week 1), week 24
measure: Change in Urine Albumin-Creatinine Ratio (UACR) [Milligram Per Gram (mg/g)]
timeFrame: Baseline (week 1), week 24
measure: Participants Discontinued Due to Adverse Events (Treatment Discontinuation)
timeFrame: From baseline (week 1) to week 24
measure: Number of Severe Hypoglycaemic Episodes
timeFrame: From baseline (week 1) to week 24
measure: Number of Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes
timeFrame: From baseline (week 1) to week 24
measure: Number of Serious Adverse Events (SAEs)
timeFrame: From baseline (week 1) to week 24
measure: Number of Adverse Reactions (ARs)
timeFrame: From baseline (week 1) to week 24
measure: Number of Serious Adverse Reactions (SARs)
timeFrame: From baseline (week 1) to week 24
measure: Number of Suspected Unexpected Serious Adverse Reactions (SUSARs) Per Participant
timeFrame: From baseline (week 1) to week 24
measure: Change From Baseline in Heart Rate (Pulse) After 24 Weeks of Treatment
timeFrame: Baseline (week 1), week 24
Other outcomes:
Locations:
city: Santiago, Región Metropolitana
country: Chile
facility: Servicios Médicos Godoy Limitada
city: Santiago, Región Metropolitana
country: Chile
facility: Hospital San Juan de Dios_Santiago, Región Metropolitana
city: Santiago, Región Metropolitana
country: Chile
facility: Hospital Padre Hurtado
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency dept. 2834
role: STUDY_DIRECTOR
References: