Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04109547
Other study ID # NN9924-4338
Secondary ID U1111-1188-11732
Status Completed
Phase Phase 3
First received
Last updated
Start date October 1, 2019
Est. completion date October 27, 2021

Study information

Verified date September 2023
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study compares 2 medicines for type 2 diabetes: oral semaglutide (a new medicine) and placebo (a dummy medicine). Researchers will test semaglutide to see how well it works compared to placebo. The study will also test if semaglutide is safe. Participants will either get semaglutide or placebo - which treatment is decided by chance. Participants will get 1 tablet a day to take with up to half a glass of water. Participants must take the tablet first thing in the morning on an empty stomach. After taking the tablet, participants must not eat or drink anything for at least 30 minutes. After the 30 minutes, participants can have their first meal of the day and take any other medicines they may need. The study will last for about 8 months (36 weeks). Participants will have 9 clinic visits and 2 phone calls with the study doctor. At all 9 of the clinic visits, participants will have blood samples taken. At 5 of the clinic visits, participants must arrive fasting. This means they cannot eat for 8 hours before the visit. It is fine to drink water up to 2 hours before the visit. This is for some of the blood samples that will be taken at the visit. Women cannot take part if pregnant, breastfeeding or planning to become pregnant during the study period.


Recruitment information / eligibility

Status Completed
Enrollment 521
Est. completion date October 27, 2021
Est. primary completion date September 23, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. - Male or female, age above or equal to 18 years at the time of signing informed consent. For Algeria only: Male or female, age above or equal to 19 years at the time of signing the informed consent. For Taiwan only: Male or female, age above or equal to 20 years at the time of signing the informed consent. - Diagnosed with type 2 diabetes mellitus - HbA1c between 7.0 -10.0% (53-86 mmol/mol) (both inclusive). Exclusion Criteria: - - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an highly effective contraceptive method. - Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC). Family is defined as a first degree relative. - History or presence of pancreatitis (acute or chronic). - History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery). - Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening. - Subjects presently classified as being in New York Heart Association (NYHA) Class IV. - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening. - Renal impairment measured as estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula(CKD-EPI). - Subjects with alanine aminotransferase (ALT) above 2.5 x upper limit of the normal (ULN). - Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Oral semaglutide
Tablets to be taken once-daily for 26 weeks
Placebo
Tablets to be taken once-daily for 26 weeks

Locations

Country Name City State
Algeria Novo Nordisk Investigational Site Algiers
Algeria Novo Nordisk Investigational Site Algiers
China Novo Nordisk Investigational Site Beijing Beijing
China Novo Nordisk Investigational Site Beijing Beijing
China Novo Nordisk Investigational Site Cangzhou Hebei
China Novo Nordisk Investigational Site Changchun Jilin
China Novo Nordisk Investigational Site Changchun Jilin
China Novo Nordisk Investigational Site Changchun Jilin
China Novo Nordisk Investigational Site Changde Hunan
China Novo Nordisk Investigational Site Changsha
China Novo Nordisk Investigational Site Changzhou Jiangsu
China Novo Nordisk Investigational Site Chengdu Sichuan
China Novo Nordisk Investigational Site Chenzhou Hunan
China Novo Nordisk Investigational Site Chongqing Chongqing
China Novo Nordisk Investigational Site ChongQing Chongqing
China Novo Nordisk Investigational Site Fuzhou Fujian
China Novo Nordisk Investigational Site Guangzhou Guangdong
China Novo Nordisk Investigational Site Guangzhou Guangdong
China Novo Nordisk Investigational Site Handan Hebei
China Novo Nordisk Investigational Site Hefei Anhui
China Novo Nordisk Investigational Site Hengshui Hebei
China Novo Nordisk Investigational Site Huai'an Jiangsu
China Novo Nordisk Investigational Site Huizhou Guangdong
China Novo Nordisk Investigational Site Jiaxing Jiangxi
China Novo Nordisk Investigational Site Jinan Shandong
China Novo Nordisk Investigational Site Jining Shandong
China Novo Nordisk Investigational Site Kunming Yunnan
China Novo Nordisk Investigational Site Nanchang Jiangxi
China Novo Nordisk Investigational Site Nanjing Jiangsu
China Novo Nordisk Investigational Site Nanjing Jiangsu
China Novo Nordisk Investigational Site Pudong New District Shanghai
China Novo Nordisk Investigational Site Qingdao Shandong
China Novo Nordisk Investigational Site Shanghai Shanghai
China Novo Nordisk Investigational Site Shanghai Shanghai
China Novo Nordisk Investigational Site Shanghai Shanghai
China Novo Nordisk Investigational Site Shanghai Shanghai
China Novo Nordisk Investigational Site Shanghai Shanghai
China Novo Nordisk Investigational Site Shantou Guangdong
China Novo Nordisk Investigational Site Shijiazhuang Hebei
China Novo Nordisk Investigational Site Shiyan Hubei
China Novo Nordisk Investigational Site Tianjin Tianjin
China Novo Nordisk Investigational Site Wuxi Jiangsu
China Novo Nordisk Investigational Site Xi'an Shaanxi
China Novo Nordisk Investigational Site Xining Qinghai
China Novo Nordisk Investigational Site Xuzhou Jiangsu
China Novo Nordisk Investigational Site Yinchuan Ningxia
China Novo Nordisk Investigational Site Yueyang Hunan
China Novo Nordisk Investigational Site Zhengzhou Henan
China Novo Nordisk Investigational Site Zhenjiang Jiangsu
Hungary Novo Nordisk Investigational Site Budapest
Hungary Novo Nordisk Investigational Site Nagykanizsa
Hungary Novo Nordisk Investigational Site Tatabánya
Hungary Novo Nordisk Investigational Site Zalaegerszeg
Serbia Novo Nordisk Investigational Site Belgrade
Serbia Novo Nordisk Investigational Site Nis
Taiwan Novo Nordisk Investigational Site Taipei
Taiwan Novo Nordisk Investigational Site Taipei
Taiwan Novo Nordisk Investigational Site Taoyuan city
Ukraine Novo Nordisk Investigational Site Dnipro
Ukraine Novo Nordisk Investigational Site Khmelnytskyi
Ukraine Novo Nordisk Investigational Site Kyiv
Ukraine Novo Nordisk Investigational Site Mykolaiv
Ukraine Novo Nordisk Investigational Site Poltava
Ukraine Novo Nordisk Investigational Site Ternopil
Ukraine Novo Nordisk Investigational Site Zaporizhia

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Algeria,  China,  Hungary,  Serbia,  Taiwan,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in Glycosylated Haemoglobin (HbA1c) Change from baseline (week 0) in HbA1c at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. Baseline (Week 0), Week 26
Secondary Change From Baseline in Body Weight (Kilograms [kg]) Change from baseline (week 0) in body weight at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. Baseline (Week 0), Week 26
Secondary Change From Baseline in Fasting Plasma Glucose (FPG) Change from baseline (week 0) in FPG at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. Baseline (Week 0), Week 26
Secondary Change From Baseline in Fasting 7-point Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile Change from baseline (week 0) in mean 7-point SMPG profile at week 26 is presented. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. Baseline (Week 0), Week 26
Secondary Change From Baseline in Fasting 7-point Self-measured Plasma Glucose Profile: Mean Postprandial Increment (Over All Meals) Change from baseline (week 0) in fasting 7-point SMPG: Mean postprandial increment (over all meals) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. Baseline (Week 0), Week 26
Secondary Change From Baseline in Body Weight (Percentage [%]) Change from baseline (week 0) in body weight (measured in kg) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. Baseline (Week 0), Week 26
Secondary Change From Baseline in Body Mass Index (BMI) Change from baseline (week 0) in BMI at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. Baseline (Week 0), Week 26
Secondary Change From Baseline in Waist Circumference Change from baseline (week 0) in waist circumference at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. Baseline (Week 0), Week 26
Secondary Change From Baseline in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline) Change from baseline (week 0) in total cholesterol (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. Baseline (Week 0), Week 26
Secondary Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline) Change from baseline (week 0) in LDL cholesterol (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. Baseline (Week 0), Week 26
Secondary Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline) Change from baseline (week 0) in HDL cholesterol (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. Baseline (Week 0), Week 26
Secondary Change From Baseline in Fasting Lipid Profile: Triglycerides (Ratio to Baseline) Change from baseline (week 0) in triglycerides (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. Baseline (Week 0), Week 26
Secondary Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey SF-36 v2.0 is a 36-item, patient-reported survey of patient health. SF-36 measures the participant's overall Health Related Quality of Life on 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) and two component summary scores (physical component summary and mental component summary). Range of score for domains and component summary scores : 1-100 (Higher scores indicated a better health state). Change form baseline in each domain, physical component summary score and mental component summary score at week 26 is presented. A positive change score indicates an improvement since baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. Baseline (Week 0), Week 26
Secondary Number of Participants Who Achieved HbA1c Less Than (<) 7.0 % (53 Millimoles Per Mole [mmol/Mol]) (American Diabetes Association (ADA) Target) (Yes/no) Number of participants who achieved HbA1c < 7.0 % (53 mmol/mol) (ADA target) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. Week 26
Secondary Number of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no) Number of participants who achieved HbA1c <= 6.5 percent (48 mmol/mol) (AACE target) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. Week 26
Secondary Number of Participants Who Achieved HbA1c Reduction Greater Than or Equal to (>=) 1 Percent (10.9 mmol/Mol) (Yes/no) Number of participants who achieved HbA1c reduction >= 1 percent (10.9 mmol/mol) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. Week 26
Secondary Number of Participants Who Achieved Body Weight Loss >= 3 Percent (Yes/no) Number of participants who achieved body weight loss >= 3 percent (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. Week 26
Secondary Number of Participants Who Achieved Body Weight Loss >= 5 Percent (Yes/no) Number of participants who achieved body weight loss >= 5 percent (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. Week 26
Secondary Number of Participants Who Achieved Body Weight Loss >= 10 Percent (Yes/no) Number of participants who achieved body weight loss >= 10 percent (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. Week 26
Secondary Number of Participants Who Achieved HbA1c < 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or Blood Glucose [BG] Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no) Number of participants who achieved HbA1c < 7.0 percent (53 mmol/mol) without hypoglycaemia (treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes) and no body weight gain (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. Week 26
Secondary Number of Participants Who Achieved HbA1c Reduction >= 1% (10.9 mmol/Mol) and Body Weight Loss >= 3 Percent (Yes/no) Number of participants who achieved HbA1c reduction >= 1% (10.9 mmol/mol) and body weight loss >= 3% (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. Week 26
Secondary Time From First Dose to Initiation of Rescue Medication Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomization and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomization and before last day on trial product. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. From baseline (Week 0) to Week 26
Secondary Semaglutide Plasma Concentrations Semaglutide plasma concentrations at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. Week 26: post dose any time
Secondary Change From Baseline in Haematology - Haematocrit (Ratio to Baseline) Change from baseline (week 0) in haematocrit (measured in %) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. Baseline (Week 0), Week 26
Secondary Change From Baseline in Haematology - Haemoglobin (Ratio to Baseline) Change from baseline (week 0) in haemoglobin (measured in millimoles per liter [mmol/L]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. Baseline (Week 0), Week 26
Secondary Change From Baseline in Haematology - Leucocytes (Ratio to Baseline) Change from baseline (week 0) in leucocytes (measured in 10^9 per liter [10^9/L]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. Baseline (Week 0), Week 26
Secondary Change From Baseline in Haematology - Thrombocytes (Ratio to Baseline) Change from baseline (week 0) in thrombocytes (measured in 10^9/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. Baseline (Week 0), Week 26
Secondary Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Change from baseline (week 0) in basophils, eosinophils, lymphocytes, monocytes and neutrophils at week 26 is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. Baseline (Week 0), Week 26
Secondary Change From Baseline in Biochemistry - Urea (Ratio to Baseline) Change from baseline (week 0) in urea (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. Baseline (Week 0), Week 26
Secondary Change From Baseline in Biochemistry - Creatinine (Ratio to Baseline) Change from baseline (week 0) in creatinine (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. Baseline (Week 0), Week 26
Secondary Change From Baseline in Biochemistry - Alanine Aminotransferase (Ratio to Baseline) Change from baseline (week 0) in alanine aminotransferase (measured in units per liter [U/L]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. Baseline (Week 0), Week 26
Secondary Change From Baseline in Biochemistry - Aspartate Aminotransferase (Ratio to Baseline) Change from baseline (week 0) in aspartate aminotransferase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. Baseline (Week 0), Week 26
Secondary Change From Baseline in Biochemistry - Alkaline Phosphatase (Ratio to Baseline) Change from baseline (week 0) in alkaline phosphatase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. Baseline (Week 0), Week 26
Secondary Change From Baseline in Biochemistry - Total Bilirubin (Ratio to Baseline) Change from baseline (week 0) in total bilirubin (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. Baseline (Week 0), Week 26
Secondary Change From Baseline in Biochemistry - Amylase (Ratio to Baseline) Change from baseline (week 0) in amylase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. Baseline (Week 0), Week 26
Secondary Change From Baseline in Biochemistry - Lipase (Ratio to Baseline) Change from baseline (week 0) in lipase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. Baseline (Week 0), Week 26
Secondary Change From Baseline in Biochemistry - Creatine Kinase (Ratio to Baseline) Change from baseline (week 0) in creatine kinase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. Baseline (Week 0), Week 26
Secondary Change From Baseline in Calcium (Ratio to Baseline) Change from baseline (week 0) in calcium (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. Baseline (Week 0), Week 26
Secondary Change From Baseline in Potassium (Ratio to Baseline) Change from baseline (week 0) in potassium (measured in milliequivalents per liter [mEq/L]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. Baseline (Week 0), Week 26
Secondary Change From Baseline in Sodium (Ratio to Baseline) Change from baseline (week 0) in sodium (measured in mEq/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. Baseline (Week 0), Week 26
Secondary Change From Baseline in Albumin (Ratio to Baseline) Change from baseline (week 0) in albumin (measured in g/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. Baseline (Week 0), Week 26
Secondary Change From Baseline in Calcitonin (Ratio to Baseline) Change from baseline (week 0) in calcitonin (measured in picograms per milliliter [pg/mL]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. Baseline (Week 0), Week 26
Secondary Change From Baseline in Pulse Rate Change from baseline (week 0) in pulse rate at week 26 is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. Baseline (Week 0), Week 26
Secondary Change From Baseline in Systolic Blood Pressure Change from baseline (week 0) in systolic blood pressure at week 26 is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. Baseline (Week 0), Week 26
Secondary Change From Baseline in Diastolic Blood Pressure Change from baseline (week 0) in diastolic blood pressure at week 26 is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. Baseline (Week 0), Week 26
Secondary Change From Baseline in Electrocardiogram (ECG) Category Change from baseline (week 0) in ECG category at week 26 is presented. Change from baseline results are presented as shift in findings categorized as: normal, abnormal and not clinically significant (NCS), and abnormal and clinically significant (CS). The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last dose of trial product plus 38 days or the end-date for the in-trial observation period. Baseline (Week 0), Week 26
Secondary Change From Baseline in Physical Examination Category Change from baseline (week 0) in physical examination category at week 26 is presented. The physical examination shift in findings were categorized as normal, abnormal NCS and abnormal CS and are presented for the following body systems: cardiovascular system; central and peripheral nervous system; gastrointestinal system, including mouth; general appearance; head, ears, eyes, nose, throat, neck; lymph node palpation; musculoskeletal system; respiratory system; skin; and thyroid gland. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. Baseline (Week 0), Week 26
Secondary Change From Baseline in Eye Examination Category Change from baseline (week 0) in eye examination category at week 26 is presented. Eye examination shift in findings were categorized as normal, abnormal NCS and abnormal CS. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period. Baseline (Week 0), Week 26
Secondary Number of Treatment-emergent Adverse Events (TEAEs) An adverse event (AE) is any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. TEAE was defined as an AE with onset in the on-treatment observation period. On-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period. Up to 31 weeks
Secondary Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the ADA classification or BG confirmed by a plasma glucose (PG) value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period. Up to 31 weeks
Secondary Number of Participants With Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the ADA classification or BG confirmed by a plasma glucose (PG) value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period. Up to 31 weeks
Secondary Anti-semaglutide Binding Antibody Levels Anti-semaglutide binding antibody levels measured anytime during post-baseline visits (week 0 to week 31) are presented. The outcome data are presented as percentage of bound radioactivity-labelled semaglutide/total added radioactivity-labelled semaglutide (%B/T). Results are based on the data from the in-trial observation period - the in-trial observation period started at randomization and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact, and death for participants who died before any of the above. Up to 31 weeks
Secondary Number of Participants With Anti-semaglutide Binding Antibodies Number of participants who had anti-semaglutide binding antibody levels anytime during post-baseline visits (week 0 to week 31) are presented. Results are based on the data from the in-trial observation period - the in-trial observation period started at randomization and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participants-investigator contact, and death for participants who died before any of the above. Up to 31 weeks
Secondary Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 Number of participants who had anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) anytime during post-baseline visits (week 0 to week 31) are presented. Results are based on the data from the in-trial observation period - the in-trial observation period started at randomization and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact, and death for participants who died before any of the above. Up to 31 weeks
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05666479 - CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
Completed NCT05647083 - The Effect of Massage on Diabetic Parameters N/A
Active, not recruiting NCT05661799 - Persistence of Physical Activity in People With Type 2 Diabetes Over Time. N/A
Completed NCT03686722 - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin Phase 1
Completed NCT02836704 - Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose) Phase 4
Completed NCT01819129 - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes Phase 3
Completed NCT04562714 - Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy N/A
Completed NCT02009488 - Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM) Phase 1
Completed NCT05896319 - Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2 N/A
Recruiting NCT05598203 - Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes N/A
Completed NCT05046873 - A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People Phase 1
Completed NCT04030091 - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus Phase 4
Terminated NCT04090242 - Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes N/A
Completed NCT03604224 - A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
Completed NCT03620357 - Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D) N/A
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Completed NCT03620890 - Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy Phase 4
Withdrawn NCT05473286 - A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
Not yet recruiting NCT05029804 - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes N/A
Completed NCT04531631 - Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes Phase 2