Phase 4
N=104
Safety Study of Weekly Semaglutide in Chilean Participants With Type 2 Diabetes
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT05533632 ↗Enrolled (actual)
104
Serious AEs
1.0%
Results posted
Feb 2025
Primary outcome: Primary: Number of Adverse Events (AEs) — 45 Events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Semaglutide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novo Nordisk A/S
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Events (AEs) |
45 | — |
| SECONDARY Change in Glycosylated Haemoglobin (HbA1c) |
-1.6 | — |
| SECONDARY Participants Achieving HbA1c Less Than (<) 7.0 Percentage (%) [Yes/No] |
52; 40 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) [Milligrams Per Decilitre (mg/dL)] |
-26.2 | — |
| SECONDARY Change in Body Weight (Kilogram [Kg]) |
-5.3 | — |
| SECONDARY Change in Waist Circumference [Centimeter (cm)] |
-5.7 | — |
| SECONDARY Participants Achieving Greater Than or Equal (≥) 5% Weight Reduction (Yes/No) |
56; 36 | — |
| SECONDARY Participants Achieving Greater Than or Equal (≥) 10% Weight Reduction (Yes/No) |
17; 75 | — |
| SECONDARY Change in Total Cholesterol (mg/dL) |
-14.1 | — |
| SECONDARY Change in Low Density Lipoprotein (LDL) Cholesterol (mg/dL) |
-12.5 | — |
| SECONDARY Change in High Density Lipoprotein (HDL) Cholesterol (mg/dL) |
-1.1 | — |
| SECONDARY Change in Triglycerides (mg/dL) |
-13.8 | — |
| SECONDARY Change in Estimated Glomerular Filtration Rate (eGFR) [Millilitre Per Minute (mL/Min) Per 1.73 Square Meter (m^2)] |
-1.1 | — |
| SECONDARY Change in Urine Albumin-Creatinine Ratio (UACR) [Milligram Per Gram (mg/g)] |
-18.0 | — |
| SECONDARY Participants Discontinued Due to Adverse Events (Treatment Discontinuation) |
4 | — |
| SECONDARY Number of Severe Hypoglycaemic Episodes |
— | — |
| SECONDARY Number of Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes |
0; 2 | — |
| SECONDARY Number of Serious Adverse Events (SAEs) |
1 | — |
| SECONDARY Number of Adverse Reactions (ARs) |
39 | — |
| SECONDARY Number of Serious Adverse Reactions (SARs) |
— | — |
| SECONDARY Number of Suspected Unexpected Serious Adverse Reactions (SUSARs) Per Participant |
— | — |
| SECONDARY Change From Baseline in Heart Rate (Pulse) After 24 Weeks of Treatment |
2.9 | — |
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).
Data sourced from ClinicalTrials.gov (NCT05533632). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.