Safety Study of Weekly Semaglutide in Chilean Participants With Type 2 Diabetes
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Semaglutide Participants will receive semaglutide subcutaneous (s.c.) injection once weekly in a dose escalation manner for 24 weeks: 0.25 milligrams (mg) (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24). |
Drug: Semaglutide
Participants will receive semaglutide s.c. injection once weekly in a dose escalation manner for 24 weeks.
|
Outcome Measures
Primary Outcome Measures
- Number of Adverse Events [From baseline to week 24]
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.
Secondary Outcome Measures
- Change in Glycosylated Haemoglobin (HbA1c) [From baseline to week 24]
Measured as percentage (%).
- Participants Achieving HbA1c Less Than 7.0 Percentage [From baseline to week 24]
Measured as yes/no.
- Change of Fasting Plasma Glucose (FPG) [From baseline to week 24]
Measured as milligrams per deciliter (mg/dL).
- Change of Body Weight [From baseline to week 24]
Measured as kilograms (kg).
- Change of Waist Circumference [From baseline to week 24]
Measured as centimeters (cm).
- Participants Achieving Greater Than Equal To (≥) 5% And ≥ 10% Weight Reduction [From baseline to week 24]
Measured as yes/no.
- Change in Laboratory Tests [From baseline to week 24]
Measured as lab test unit correspondent.
- Participants Discontinued Due to Adverse Events (Treatment Discontinuation) [From baseline to week 24]
Measured as yes/no.
- Number of Severe Hypoglycaemic Episodes Per Participant [From baseline to week 24]
Measured as number of episodes
- Number of Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes Per Participant [From baseline to week 24]
Measured as number of episodes
- Number of Serious Adverse Events (SAEs) Per Participant [From baseline to week 24]
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.
- Number of Adverse Reactions (ARs) Per Participant [From baseline to week 24]
Measured as number of events
- Number of Serious Adverse Reactions (SARs) Per Participant [From baseline to week 24]
Measured as number of events
- Number of Suspected Unexpected Serious Adverse Reactions (SUSARs) Per Participant [From baseline to week 24]
Measured as number of events
- Change From Baseline in Heart Rate (Pulse) After 24 Weeks of Treatment [From baseline to week 24]
Measured as beats per minute (bpm).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participants diagnosed (clinically) with type 2 diabetes greater than equal to (≥) 90 days prior to the screening visit.
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Stable daily dose of Oral Antidiabetic Drug (OAD) and/or insulin treatment for ≥ 60 days prior to the screening visit.
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HbA1c 7.5-10% (59-86 millimoles per mole [mmol/mol]) (both inclusive) in Visit 1.
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Participants in which Ozempic is indicated according to approved local label.
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Fundoscopy/Fundus photography record less than equal to (≤) 12 months.
Exclusion Criteria:
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Known or suspected hypersensitivity to study intervention(s) or related products.
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Previous participation in this study. Participation is defined as signed informed consent.
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Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
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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).
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Treatment with any glucagon-like peptide-1 receptor agonists (GLP-1 RA) medication prior to the screening visit.
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Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
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Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma.
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History of pancreatitis (acute or chronic).
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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).
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Myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening.
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Participants presently classified as being in New York Heart Association (NYHA) Class IV heart failure.
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Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
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Participants with alanine aminotransferase (ALT) > 2.5 x upper normal limit (UNL).
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Use of systemic immunosuppressive treatment within 90 days prior to screening.
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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.
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Known hypoglycaemic unawareness and/or recurrent severe hypoglycaemic episodes as judged by the investigator.
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Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 12 months prior to screening.
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History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Santiago, Región Metropolitana | Chile | 7500710 | |
| 2 | Novo Nordisk Investigational Site | Santiago, Región Metropolitana | Chile | 8350429 | |
| 3 | Novo Nordisk Investigational Site | Santiago, Región Metropolitana | Chile | 8880465 |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NN9535-4844
- U1111-1281-5677