Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is globally conducted. The aim of this trial is to investigate Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation versus Sitagliptin in Subjects with Type 2 Diabetes Mellitus.
Interventions
DRUGsemaglutide
Oral administration once-daily.
DRUGsitagliptin
Oral administration once-daily.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main phase (the inclusion criteria for the main phase are not reassessed for the extension phase): * 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 Korea only: Male or female, age above or equal to 19 years at the time of signing informed consent * Diagnosed with type 2 diabetes mellitus for at least 90 days prior to day of screening * HbA1c (glycosylated haemoglobin) 7.5-9.5% (58-80 mmol/mol) (both inclusive) * Treatment target of HbA1c below 7.0% (53 mmol/mol), as judged by the investigator * Stable daily dose(s) of 1-2 of the following anti-diabetic drugs within 90 days prior to the day of screening: * Metformin (equal or above 1500 mg or maximum tolerated dose as documented in the subject medical record) * Sulfonylureas (equal or above half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) * Sodium glucose co-transporter 2 inhibitors * Thiazolidinediones (equal or above half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) Extension phase: * Informed consent for the extension phase obtained before any trial-related activities for the extension phase. * On randomised treatment with or without rescue medication at week 52.
Exclusion criteria
Main phase (the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 52 | Participants who achieved HbA1c \<7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at week 52. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | Week 0, week 52 | Change from baseline (week 0) in HbA1c was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in FPG | Week 0, week 52 | Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in Body Weight (%) | Week 0, week 52 | Relative change from baseline (week 0) in body weight (kg) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in BMI | Week 0, Week 52 | Change from baseline (week 0) in body mass index (BMI) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in Waist Circumference | Week 0, week 52 | Change from baseline (week 0) in waist circumference was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in Total Cholesterol (Ratio to Baseline) | Week 0, Week 52 | Change from baseline (week 0) in total cholesterol (mmol/L) at week 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in LDL Cholesterol (Ratio to Baseline) | Week 0, week 52 | Change from baseline (week 0) in low-density lipoprotein (LDL) cholesterol (mmol/L) at week 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in HDL Cholesterol (Ratio to Baseline) | Week 0, week 52 | Change from baseline (week 0) in high-density lipoprotein (HDL) cholesterol (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in Triglycerides (Ratio to Baseline) | Week 0, week 52 | Change from baseline (week 0) in triglycerides (mmol/L) at week 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Week 0, week 52 | SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at week 52. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period. |
| Change in DTSQ | Week 0, Week 52 | Change from baseline (week 0) in diabetes treatment satisfaction questionnaire - status (DTSQs) was evaluated at week 52. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of high blood sugars and low blood sugars, respectively. Thus, lower scores indicate a perception of blood glucose levels being none of the time unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score ranges 0-36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. Results are based on the data from the in-trial observation period. |
| Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 52 | Participants who achieved HbA1c less than or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no) at week 52 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 52 | Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 52 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Participants Who Achieve Weight Loss ≥10% (Yes/no) | Week 52 | Participants who achieved weight loss more than or equal to 10% of their baseline body weight (yes/no) at week 52 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 52 | Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at week 52 is presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 52 | Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at week 52 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Time to Rescue Medication | Weeks 0-52 | Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 52. 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 randomisation (week 0) 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 randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation. |
| Time to Additional Anti-diabetic Medication | Weeks 0-52 | Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the period from week 0 to week 52. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 52), 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 randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Number of TEAEs During Exposure to Trial Product | Week 0-57 | Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period for participants who continued in the extension phase; 52-week treatment period plus the 5-week follow-up period for participants who did not continue in the extension phase). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | Week 0-57 | Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-57 (52-week treatment period for participants who continued in the extension phase; 52-week treatment period plus the 5-week follow-up period for participants who did not continue in the extension phase). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. |
| Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no) | Week 0-57 | Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-57 (52-week treatment period for participants who continued in the extension phase; 52-week treatment period plus the 5-week follow-up period for participants who did not continue in the extension phase). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. |
| Change in Amylase (Ratio to Baseline) | Week 0, Week 52 | Change from baseline (week 0) in biochemical parameter- amylase (units per liter \[U/L\]) to week 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Change in Lipase (Ratio to Baseline) | Week 0, Week 52 | Change from baseline (week 0) in lipase (U/L) to week 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Change in Pulse Rate | Week 0, week 52 | Change from baseline (week 0) in pulse rate was evaluated at week 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Week 0, week 52 | Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at week 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Change in HbA1c- Switch | Week 52, week 104 | Change from week 52 in HbA1c was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in Body Weight- Switch | Week 52, week 104 | Change from week 52 in body weight was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in Body Weight (%)- Switch | Week 52, week 104 | Relative change from week 52 in body weight (kg) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in FPG- Switch | Week 52, week 104 | Change from week 52 in fasting plasma glucose (FPG) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in BMI- Switch | Week 52, Week 104 | Change from week 52 in body mass index (BMI) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in Waist Circumference- Switch | Week 52, week 104 | Change from week 52 in waist circumference was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)- Switch | Week 104 (i.e., after 52 weeks of treatment in the extension phase) | Participants who achieved HbA1c \<7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at week 104. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)- Switch | Week 104 (i.e., after 52 weeks of treatment in the extension phase) | Participants who achieved HbA1c less than or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no) at week 104 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Participants Who Achieve Weight Loss ≥5% (Yes/no)- Switch | Week 104 (i.e., after 52 weeks of treatment in the extension phase) | Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 104 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)- Switch | Week 104 (i.e., after 52 weeks of treatment in the extension phase) | Participants who achieved HbA1c less than 7.0% without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at week 104 is presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target and no Need for Rescue Medication (Yes/no)- Switch | Week 104 (i.e., after 52 weeks of treatment in the extension phase) | Participants who achieved HbA1c \<7.0% (American Diabetes Association (ADA) target) and no need for rescue medication (yes/no), was evaluated at week 104. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation. |
| Time to Additional Anti-diabetic Medication- Switch | Weeks 53-104 | Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the period from week 53 to week 104. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after re-randomisation (week 52) and before (planned) end-of-treatment (week 104), 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 randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Time to Rescue Medication- Switch | Weeks 53-104 | Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 53 to week 104. 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 re-randomisation (week 52) 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 randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation. |
| Number of TEAEs During Exposure to Trial Product- Switch | Week 53-109 | Treatment emergent adverse events (TEAEs) were recorded from week 53 to week 109. Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Change in Amylase (Ratio to Baseline)- Switch | Week 52, Week 104 | Change from week 52 in biochemical parameter- amylase (U/L) to week 104 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Change in Lipase (Ratio to Baseline)- Switch | Week 52, Week 104 | Change from week 52 in lipase (U/L) to week 104 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Change in Pulse Rate- Switch | Week 52, week 104 | Change from week 52 in pulse rate was evaluated at week 104. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Change in Blood Pressure (Systolic and Diastolic Blood Pressure)- Switch | Week 52, week 104 | Change from week 52 in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at week 104. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes- Switch | Week 53-109 | Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 53 to 109. Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. |
| Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)- Switch | Week 53-109 | Number of participants with treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 53 to 109. Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. |
| Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch | Week 52, week 104 | SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from week 52 in the domain scores and component summary (PCS and MCS) scores were evaluated at week 104. A positive change score indicates an improvement since week 52. Results are based on the data from the in-trial observation period. |
| Change in DTSQ- Switch | Week 52, week 104 | Change from week 52 in diabetes treatment satisfaction questionnaire - status (DTSQs) was evaluated at week 104. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of high blood sugars and low blood sugars, respectively. Thus, lower scores indicate a perception of blood glucose levels being none of the time unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score ranges 0-36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. Results are based on the data from the in-trial observation period. |
| Change in HbA1c- Sustainability | Week 0, week 104 | Change from baseline (week 0) in HbA1c was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in Body Weight (kg)- Sustainability | Week 0, week 104 | Change from baseline (week 0) in body weight was evaluated at week 104. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in Body Weight (%)- Sustainability | Week 0, week 104 | Relative change from baseline (week 0) in body weight (kg) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in FPG- Sustainability | Week 0, week 104 | Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in BMI- Sustainability | Week 0, Week 104 | Change from baseline (week 0) in body mass index (BMI) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in Waist Circumference- Sustainability | Week 0, week 104 | Change from baseline (week 0) in waist circumference was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)- Sustainability | Week 104 | Participants who achieved HbA1c \<7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at week 104. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)- Sustainability | Week 104 | Participants who achieved HbA1c less than or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no) at week 104 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Participants Who Achieve Weight Loss ≥5% (Yes/no)- Sustainability | Week 104 | Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 104 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)- Sustainability | Week 104 | Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at week 104 is presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target or HbA1c Reduction ≥ 1%-Point (10.9 mmol/Mol) (Yes/no)- Sustainability | Week 104 | Participants who achieved HbA1c \<7.0% ADA target or HbA1c reduction ≥ 1%-point (10.9 mmol/mol) (yes/no), was evaluated at week 104. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Number of TEAEs During Exposure to Trial Product- Sustainability | Week 0-109 | Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 109 ((104-week treatment period for participants who continued in the extension phase or 52-week treatment period for participants who did not continue in the extension phase) plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Change in Body Weight | Week 0, week 52 | Change from baseline (week 0) in body weight was evaluated at week 52. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation. |
| Change in Lipase (Ratio to Baseline)- Sustainability | Week 0, Week 104 | Change from baseline (week 0) in lipase (U/L) to week 104 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Change in Pulse Rate- Sustainability | Week 0, week 104 | Change from baseline (week 0) in pulse rate was evaluated at week 104. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Change in Blood Pressure (Systolic and Diastolic Blood Pressure)- Sustainability | Week 0, week 104 | Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at week 104. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes)- Sustainability | Week 0-109 | Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-109 ((104-week treatment period for participants who continued in the extension phase or 52-week treatment period for participants who did not continue in the extension phase) plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. |
| Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)- Sustainability | Week 0-109 | Number of participants with treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-109 ((104-week treatment period for participants who continued in the extension phase or 52-week treatment period for participants who did not continue in the extension phase) plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. |
| Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Sustainability | Week 0, week 104 | Short form (SF)-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at week 104. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period. |
| Change in DTSQ- Sustainability | Week 0, week 104 | Change from week 0 in diabetes treatment satisfaction questionnaire - status (DTSQs) was evaluated at week 104. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of high blood sugars and low blood sugars, respectively. Thus, lower scores indicate a perception of blood glucose levels being none of the time unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score ranges 0-36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. Results are based on the data from the in-trial observation period. |
| Change in Amylase (Ratio to Baseline)- Sustainability | Week 0, week 104 | Change from baseline (week 0) in biochemical parameter- amylase (units per liter \[U/L\]) to week 104 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
Countries
Argentina, Austria, Belgium, Brazil, Egypt, Norway, South Korea, Switzerland, Turkey (Türkiye), United States
Participant flow
Recruitment details
The main phase of the trial was conducted at 77 sites in 10 countries, and the extension phase (Switch) at 71 sites in 9 countries, as follows (main phase/extension phase): Argentina (3/3), Austria (3/3), Belgium (7/7), Brazil (2/0), Egypt (4/4), Norway (4/4), South Korea (7/7), Switzerland (8/5), Turkey (8/8), and United States (31/30).
Pre-assignment details
The trial consisted of two treatment periods: a 52-week main phase and a 52-week extension phase. In Switch, participants were allowed to re-randomise from sitagliptin to oral semaglutide. Sustainability included results for participants who received oral semaglutide during main + extension phase.
Participants by arm
| Arm | Count |
|---|---|
| Oral Semaglutide Flex Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants who were still on treatment at week 52 were allowed to continue on oral semaglutide in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial. | 253 |
| Sitagliptin 100 mg Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants who were still on treatment at week 52 were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial. | 251 |
| Total | 504 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Extension Phase: 53 - 104 Weeks | Lost to Follow-up | 2 | 0 | 0 | 0 |
| Extension Phase: 53 - 104 Weeks | Other | 0 | 0 | 1 | 0 |
| Extension Phase: 53 - 104 Weeks | Withdrawal by Subject | 1 | 0 | 0 | 0 |
| Main Phase: 0 - 52 Weeks | Death | 0 | 2 | 0 | 0 |
| Main Phase: 0 - 52 Weeks | Lost to Follow-up | 7 | 4 | 0 | 0 |
| Main Phase: 0 - 52 Weeks | Withdrawal by Subject | 5 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Oral Semaglutide Flex | Sitagliptin 100 mg |
|---|---|---|---|
| Age, Continuous | 57 Years STANDARD_DEVIATION 10 | 57 Years STANDARD_DEVIATION 10 | 58 Years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 105 Participants | 48 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 399 Participants | 205 Participants | 194 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 72 Participants | 34 Participants | 38 Participants |
| Race/Ethnicity, Customized Race Black or African American | 47 Participants | 22 Participants | 25 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Other | 4 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race White | 381 Participants | 195 Participants | 186 Participants |
| Sex: Female, Male Female | 219 Participants | 108 Participants | 111 Participants |
| Sex: Female, Male Male | 285 Participants | 145 Participants | 140 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 253 | 2 / 250 | 0 / 253 | 0 / 100 | 0 / 97 |
| other Total, other adverse events | 126 / 253 | 70 / 250 | 148 / 253 | 46 / 100 | 27 / 97 |
| serious Total, serious adverse events | 24 / 253 | 24 / 250 | 36 / 253 | 9 / 100 | 7 / 97 |
Outcome results
Primary
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)
Participants who achieved HbA1c \<7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at week 52. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Time frame: Week 52
Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | In-trial | Yes | 134 Participants |
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | In-trial | No | 96 Participants |
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | On-treatment without rescue medication | Yes | 123 Participants |
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | On-treatment without rescue medication | No | 73 Participants |
| Sitagliptin 100 mg- Main Phase | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | On-treatment without rescue medication | No | 132 Participants |
| Sitagliptin 100 mg- Main Phase | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | In-trial | Yes | 60 Participants |
| Sitagliptin 100 mg- Main Phase | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | On-treatment without rescue medication | Yes | 52 Participants |
| Sitagliptin 100 mg- Main Phase | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | In-trial | No | 178 Participants |
Comparison: The analysis was based on a pattern mixture model using multiple imputation to handle missing week 52 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using a logistic regression model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.p-value: <0.000195% CI: [2.89, 6.7]Pattern mixture model
Comparison: The analysis was based on multiple imputation, imputing sequentially using post-baseline measurements up to and including week 52. The imputed data sets were analysed using a logistic regression model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.p-value: <0.000195% CI: [3.54, 8.68]Regression, Logistic
Secondary
Change in Amylase (Ratio to Baseline)
Change from baseline (week 0) in biochemical parameter- amylase (units per liter \[U/L\]) to week 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, Week 52
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in Amylase (Ratio to Baseline) | 1.14 Ratio of amylase | Geometric Coefficient of Variation 25.5 |
| Sitagliptin 100 mg- Main Phase | Change in Amylase (Ratio to Baseline) | 1.08 Ratio of amylase | Geometric Coefficient of Variation 26.3 |
Secondary
Change in Amylase (Ratio to Baseline)- Sustainability
Change from baseline (week 0) in biochemical parameter- amylase (units per liter \[U/L\]) to week 104 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 104
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in Amylase (Ratio to Baseline)- Sustainability | 1.13 Ratio of amylase | Geometric Coefficient of Variation 25.1 |
Secondary
Change in Amylase (Ratio to Baseline)- Switch
Change from week 52 in biochemical parameter- amylase (U/L) to week 104 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 52, Week 104
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in Amylase (Ratio to Baseline)- Switch | 1.09 Ratio of amylase | Geometric Coefficient of Variation 22.9 |
| Sitagliptin 100 mg- Main Phase | Change in Amylase (Ratio to Baseline)- Switch | 1.00 Ratio of amylase | Geometric Coefficient of Variation 26.6 |
Secondary
Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at week 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 52
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Systolic blood pressure | -3 Millimeters of mercury (mmHg) | Standard Deviation 14 |
| Oral Semaglutide Flex- Main Phase | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure | -0 Millimeters of mercury (mmHg) | Standard Deviation 9 |
| Sitagliptin 100 mg- Main Phase | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Systolic blood pressure | -2 Millimeters of mercury (mmHg) | Standard Deviation 15 |
| Sitagliptin 100 mg- Main Phase | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure | -1 Millimeters of mercury (mmHg) | Standard Deviation 10 |
Secondary
Change in Blood Pressure (Systolic and Diastolic Blood Pressure)- Sustainability
Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at week 104. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 104
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in Blood Pressure (Systolic and Diastolic Blood Pressure)- Sustainability | Systolic blood pressure | -3 Millimeters of mercury (mmHg) | Standard Deviation 14 |
| Oral Semaglutide Flex- Main Phase | Change in Blood Pressure (Systolic and Diastolic Blood Pressure)- Sustainability | Diastolic blood pressure | -1 Millimeters of mercury (mmHg) | Standard Deviation 9 |
Secondary
Change in Blood Pressure (Systolic and Diastolic Blood Pressure)- Switch
Change from week 52 in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at week 104. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 52, week 104
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in Blood Pressure (Systolic and Diastolic Blood Pressure)- Switch | Systolic blood pressure | -3 Millimeters of mercury (mmHg) | Standard Deviation 15 |
| Oral Semaglutide Flex- Main Phase | Change in Blood Pressure (Systolic and Diastolic Blood Pressure)- Switch | Diastolic blood pressure | -1 Millimeters of mercury (mmHg) | Standard Deviation 10 |
| Sitagliptin 100 mg- Main Phase | Change in Blood Pressure (Systolic and Diastolic Blood Pressure)- Switch | Systolic blood pressure | 2 Millimeters of mercury (mmHg) | Standard Deviation 15 |
| Sitagliptin 100 mg- Main Phase | Change in Blood Pressure (Systolic and Diastolic Blood Pressure)- Switch | Diastolic blood pressure | -0 Millimeters of mercury (mmHg) | Standard Deviation 10 |
Secondary
Change in BMI
Change from baseline (week 0) in body mass index (BMI) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, Week 52
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in BMI | -1.0 Kilograms per square meter (kg/m^2) | Standard Deviation 1.5 |
| Sitagliptin 100 mg- Main Phase | Change in BMI | -0.3 Kilograms per square meter (kg/m^2) | Standard Deviation 1.3 |
Secondary
Change in BMI- Sustainability
Change from baseline (week 0) in body mass index (BMI) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, Week 104
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in BMI- Sustainability | -1.3 kg/m^2 | Standard Deviation 1.9 |
Secondary
Change in BMI- Switch
Change from week 52 in body mass index (BMI) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 52, Week 104
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in BMI- Switch | -0.9 kg/m^2 | Standard Deviation 1.4 |
| Sitagliptin 100 mg- Main Phase | Change in BMI- Switch | -0.3 kg/m^2 | Standard Deviation 2.2 |
Secondary
Change in Body Weight
Change from baseline (week 0) in body weight was evaluated at week 52. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Time frame: Week 0, week 52
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in Body Weight | In-trial | -2.7 Kilogram (Kg) | Standard Deviation 3.9 |
| Oral Semaglutide Flex- Main Phase | Change in Body Weight | On-treatment without rescue medication | -2.9 Kilogram (Kg) | Standard Deviation 4 |
| Sitagliptin 100 mg- Main Phase | Change in Body Weight | In-trial | -0.7 Kilogram (Kg) | Standard Deviation 3.5 |
| Sitagliptin 100 mg- Main Phase | Change in Body Weight | On-treatment without rescue medication | -0.9 Kilogram (Kg) | Standard Deviation 3.6 |
Comparison: The analysis was based on a pattern mixture model using multiple imputation to handle missing week 52 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using a logistic regression model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.p-value: <0.000195% CI: [-2.6, -1.2]Pattern mixture model
Comparison: The analysis was based on a Mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 52. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.p-value: <0.000195% CI: [-2.9, -1.5]Mixed model for repeated measurements
Secondary
Change in Body Weight (%)
Relative change from baseline (week 0) in body weight (kg) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 52
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in Body Weight (%) | -2.99 Percentage change | Standard Deviation 4.42 |
| Sitagliptin 100 mg- Main Phase | Change in Body Weight (%) | -0.76 Percentage change | Standard Deviation 3.91 |
Secondary
Change in Body Weight (kg)- Sustainability
Change from baseline (week 0) in body weight was evaluated at week 104. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 104
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in Body Weight (kg)- Sustainability | -3.7 Kg | Standard Deviation 5.2 |
Secondary
Change in Body Weight (%)- Sustainability
Relative change from baseline (week 0) in body weight (kg) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 104
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in Body Weight (%)- Sustainability | -4.03 Percentage change | Standard Deviation 5.75 |
Secondary
Change in Body Weight (%)- Switch
Relative change from week 52 in body weight (kg) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 52, week 104
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in Body Weight (%)- Switch | -3.12 Percentage change | Standard Deviation 4.5 |
| Sitagliptin 100 mg- Main Phase | Change in Body Weight (%)- Switch | -0.70 Percentage change | Standard Deviation 5.27 |
Secondary
Change in Body Weight- Switch
Change from week 52 in body weight was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 52, week 104
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in Body Weight- Switch | -2.6 Kg | Standard Deviation 3.8 |
| Sitagliptin 100 mg- Main Phase | Change in Body Weight- Switch | -0.9 Kg | Standard Deviation 5.4 |
Secondary
Change in DTSQ
Change from baseline (week 0) in diabetes treatment satisfaction questionnaire - status (DTSQs) was evaluated at week 52. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of high blood sugars and low blood sugars, respectively. Thus, lower scores indicate a perception of blood glucose levels being none of the time unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score ranges 0-36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. Results are based on the data from the in-trial observation period.
Time frame: Week 0, Week 52
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in DTSQ | 2) Feeling of unacceptably high blood sugars | -1.58 Score on a scale | Standard Deviation 2.13 |
| Oral Semaglutide Flex- Main Phase | Change in DTSQ | 6) Satisfaction with understanding of diabetes | 0.77 Score on a scale | Standard Deviation 1.51 |
| Oral Semaglutide Flex- Main Phase | Change in DTSQ | 4) Convenience of treatment | 0.82 Score on a scale | Standard Deviation 1.54 |
| Oral Semaglutide Flex- Main Phase | Change in DTSQ | 7) Recommending treatment to others | 0.88 Score on a scale | Standard Deviation 1.54 |
| Oral Semaglutide Flex- Main Phase | Change in DTSQ | 3) Feeling of unacceptably low blood sugars | -0.15 Score on a scale | Standard Deviation 1.7 |
| Oral Semaglutide Flex- Main Phase | Change in DTSQ | 8) Satisfaction to continue with present treatment | 1.03 Score on a scale | Standard Deviation 1.66 |
| Oral Semaglutide Flex- Main Phase | Change in DTSQ | 5) Flexibility of current treatment | 0.80 Score on a scale | Standard Deviation 1.58 |
| Oral Semaglutide Flex- Main Phase | Change in DTSQ | Total treatment satisfaction score | 5.39 Score on a scale | Standard Deviation 6.84 |
| Oral Semaglutide Flex- Main Phase | Change in DTSQ | 1) Satisfaction with treatment | 1.09 Score on a scale | Standard Deviation 1.61 |
| Sitagliptin 100 mg- Main Phase | Change in DTSQ | Total treatment satisfaction score | 4.70 Score on a scale | Standard Deviation 7.23 |
| Sitagliptin 100 mg- Main Phase | Change in DTSQ | 1) Satisfaction with treatment | 0.92 Score on a scale | Standard Deviation 1.65 |
| Sitagliptin 100 mg- Main Phase | Change in DTSQ | 2) Feeling of unacceptably high blood sugars | -1.14 Score on a scale | Standard Deviation 2.13 |
| Sitagliptin 100 mg- Main Phase | Change in DTSQ | 3) Feeling of unacceptably low blood sugars | -0.24 Score on a scale | Standard Deviation 1.99 |
| Sitagliptin 100 mg- Main Phase | Change in DTSQ | 4) Convenience of treatment | 0.59 Score on a scale | Standard Deviation 1.48 |
| Sitagliptin 100 mg- Main Phase | Change in DTSQ | 5) Flexibility of current treatment | 0.68 Score on a scale | Standard Deviation 1.51 |
| Sitagliptin 100 mg- Main Phase | Change in DTSQ | 6) Satisfaction with understanding of diabetes | 0.77 Score on a scale | Standard Deviation 1.71 |
| Sitagliptin 100 mg- Main Phase | Change in DTSQ | 7) Recommending treatment to others | 0.79 Score on a scale | Standard Deviation 1.46 |
| Sitagliptin 100 mg- Main Phase | Change in DTSQ | 8) Satisfaction to continue with present treatment | 0.95 Score on a scale | Standard Deviation 1.88 |
Secondary
Change in DTSQ- Sustainability
Change from week 0 in diabetes treatment satisfaction questionnaire - status (DTSQs) was evaluated at week 104. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of high blood sugars and low blood sugars, respectively. Thus, lower scores indicate a perception of blood glucose levels being none of the time unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score ranges 0-36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. Results are based on the data from the in-trial observation period.
Time frame: Week 0, week 104
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in DTSQ- Sustainability | 1) Satisfaction with treatment | 1.19 Score on a scale | Standard Deviation 1.61 |
| Oral Semaglutide Flex- Main Phase | Change in DTSQ- Sustainability | 2) Feeling of unacceptably high blood sugars | -1.46 Score on a scale | Standard Deviation 2.44 |
| Oral Semaglutide Flex- Main Phase | Change in DTSQ- Sustainability | 3) Feeling of unacceptably low blood sugars | -0.14 Score on a scale | Standard Deviation 2.09 |
| Oral Semaglutide Flex- Main Phase | Change in DTSQ- Sustainability | 4) Convenience of treatment | 0.88 Score on a scale | Standard Deviation 1.52 |
| Oral Semaglutide Flex- Main Phase | Change in DTSQ- Sustainability | 5) Flexibility of current treatment | 0.86 Score on a scale | Standard Deviation 1.56 |
| Oral Semaglutide Flex- Main Phase | Change in DTSQ- Sustainability | 6) Satisfaction with understanding of diabetes | 0.84 Score on a scale | Standard Deviation 1.5 |
| Oral Semaglutide Flex- Main Phase | Change in DTSQ- Sustainability | 7) Recommending treatment to others | 0.94 Score on a scale | Standard Deviation 1.58 |
| Oral Semaglutide Flex- Main Phase | Change in DTSQ- Sustainability | 8) Satisfaction to continue with present treatment | 1.11 Score on a scale | Standard Deviation 1.62 |
| Oral Semaglutide Flex- Main Phase | Change in DTSQ- Sustainability | Total treatment satisfaction score | 5.81 Score on a scale | Standard Deviation 7.11 |
Secondary
Change in DTSQ- Switch
Change from week 52 in diabetes treatment satisfaction questionnaire - status (DTSQs) was evaluated at week 104. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of high blood sugars and low blood sugars, respectively. Thus, lower scores indicate a perception of blood glucose levels being none of the time unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score ranges 0-36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. Results are based on the data from the in-trial observation period.
Time frame: Week 52, week 104
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in DTSQ- Switch | 5) Flexibility of current treatment | 0.01 Score on a scale | Standard Deviation 1.19 |
| Oral Semaglutide Flex- Main Phase | Change in DTSQ- Switch | 6) Satisfaction with understanding of diabetes | 0.02 Score on a scale | Standard Deviation 1.38 |
| Oral Semaglutide Flex- Main Phase | Change in DTSQ- Switch | 3) Feeling of unacceptably low blood sugars | 0.02 Score on a scale | Standard Deviation 1.63 |
| Oral Semaglutide Flex- Main Phase | Change in DTSQ- Switch | 7) Recommending treatment to others | 0.04 Score on a scale | Standard Deviation 1.04 |
| Oral Semaglutide Flex- Main Phase | Change in DTSQ- Switch | 2) Feeling of unacceptably high blood sugars | -0.32 Score on a scale | Standard Deviation 1.95 |
| Oral Semaglutide Flex- Main Phase | Change in DTSQ- Switch | 8) Satisfaction to continue with present treatment | -0.05 Score on a scale | Standard Deviation 1.07 |
| Oral Semaglutide Flex- Main Phase | Change in DTSQ- Switch | 4) Convenience of treatment | 0.13 Score on a scale | Standard Deviation 1.18 |
| Oral Semaglutide Flex- Main Phase | Change in DTSQ- Switch | Total treatment satisfaction score | 0.20 Score on a scale | Standard Deviation 5.14 |
| Oral Semaglutide Flex- Main Phase | Change in DTSQ- Switch | 1) Satisfaction with treatment | 0.06 Score on a scale | Standard Deviation 1.06 |
| Sitagliptin 100 mg- Main Phase | Change in DTSQ- Switch | Total treatment satisfaction score | -0.06 Score on a scale | Standard Deviation 5.62 |
| Sitagliptin 100 mg- Main Phase | Change in DTSQ- Switch | 1) Satisfaction with treatment | -0.24 Score on a scale | Standard Deviation 1.43 |
| Sitagliptin 100 mg- Main Phase | Change in DTSQ- Switch | 2) Feeling of unacceptably high blood sugars | 0.09 Score on a scale | Standard Deviation 2.04 |
| Sitagliptin 100 mg- Main Phase | Change in DTSQ- Switch | 3) Feeling of unacceptably low blood sugars | 0.23 Score on a scale | Standard Deviation 1.94 |
| Sitagliptin 100 mg- Main Phase | Change in DTSQ- Switch | 4) Convenience of treatment | 0.13 Score on a scale | Standard Deviation 1.16 |
| Sitagliptin 100 mg- Main Phase | Change in DTSQ- Switch | 6) Satisfaction with understanding of diabetes | 0.04 Score on a scale | Standard Deviation 1.16 |
| Sitagliptin 100 mg- Main Phase | Change in DTSQ- Switch | 7) Recommending treatment to others | -0.05 Score on a scale | Standard Deviation 1.2 |
| Sitagliptin 100 mg- Main Phase | Change in DTSQ- Switch | 8) Satisfaction to continue with present treatment | 0.00 Score on a scale | Standard Deviation 1.48 |
| Sitagliptin 100 mg- Main Phase | Change in DTSQ- Switch | 5) Flexibility of current treatment | 0.06 Score on a scale | Standard Deviation 1.22 |
Secondary
Change in FPG
Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 52
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in FPG | -2.41 Millimoles per liter (mmol/L) | Standard Deviation 2.35 |
| Sitagliptin 100 mg- Main Phase | Change in FPG | -1.39 Millimoles per liter (mmol/L) | Standard Deviation 3.13 |
Secondary
Change in FPG- Sustainability
Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 104
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in FPG- Sustainability | -39.4 Millimoles per liter (mmol/L) | Standard Deviation 51.2 |
Secondary
Change in FPG- Switch
Change from week 52 in fasting plasma glucose (FPG) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 52, week 104
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in FPG- Switch | -0.35 Millimoles per liter (mmol/L) | Standard Deviation 1.95 |
| Sitagliptin 100 mg- Main Phase | Change in FPG- Switch | 0.02 Millimoles per liter (mmol/L) | Standard Deviation 2.31 |
Secondary
Change in HbA1c
Change from baseline (week 0) in HbA1c was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 52
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in HbA1c | -1.3 Percentage of HbA1c | Standard Deviation 0.9 |
| Sitagliptin 100 mg- Main Phase | Change in HbA1c | -0.8 Percentage of HbA1c | Standard Deviation 1 |
Secondary
Change in HbA1c- Sustainability
Change from baseline (week 0) in HbA1c was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 104
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in HbA1c- Sustainability | -1.3 Percentage of HbA1c | Standard Deviation 1 |
Secondary
Change in HbA1c- Switch
Change from week 52 in HbA1c was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 52, week 104
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in HbA1c- Switch | -0.2 Percentage of HbA1c | Standard Deviation 1.2 |
| Sitagliptin 100 mg- Main Phase | Change in HbA1c- Switch | 0.0 Percentage of HbA1c | Standard Deviation 1 |
Secondary
Change in HDL Cholesterol (Ratio to Baseline)
Change from baseline (week 0) in high-density lipoprotein (HDL) cholesterol (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 52
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in HDL Cholesterol (Ratio to Baseline) | 1.00 Ratio of HDL cholesterol | Geometric Coefficient of Variation 14 |
| Sitagliptin 100 mg- Main Phase | Change in HDL Cholesterol (Ratio to Baseline) | 1.02 Ratio of HDL cholesterol | Geometric Coefficient of Variation 16.5 |
Secondary
Change in LDL Cholesterol (Ratio to Baseline)
Change from baseline (week 0) in low-density lipoprotein (LDL) cholesterol (mmol/L) at week 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 52
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in LDL Cholesterol (Ratio to Baseline) | 0.97 Ratio of LDL cholesterol | Geometric Coefficient of Variation 31.8 |
| Sitagliptin 100 mg- Main Phase | Change in LDL Cholesterol (Ratio to Baseline) | 1.03 Ratio of LDL cholesterol | Geometric Coefficient of Variation 27.2 |
Secondary
Change in Lipase (Ratio to Baseline)
Change from baseline (week 0) in lipase (U/L) to week 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, Week 52
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in Lipase (Ratio to Baseline) | 1.24 Ratio of lipase | Geometric Coefficient of Variation 55.2 |
| Sitagliptin 100 mg- Main Phase | Change in Lipase (Ratio to Baseline) | 1.13 Ratio of lipase | Geometric Coefficient of Variation 55.3 |
Secondary
Change in Lipase (Ratio to Baseline)- Sustainability
Change from baseline (week 0) in lipase (U/L) to week 104 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, Week 104
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in Lipase (Ratio to Baseline)- Sustainability | 1.18 Ratio of lipase | Geometric Coefficient of Variation 58 |
Secondary
Change in Lipase (Ratio to Baseline)- Switch
Change from week 52 in lipase (U/L) to week 104 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 52, Week 104
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in Lipase (Ratio to Baseline)- Switch | 1.13 Ratio of lipase | Geometric Coefficient of Variation 46.7 |
| Sitagliptin 100 mg- Main Phase | Change in Lipase (Ratio to Baseline)- Switch | 0.92 Ratio of lipase | Geometric Coefficient of Variation 54.9 |
Secondary
Change in Pulse Rate
Change from baseline (week 0) in pulse rate was evaluated at week 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 52
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in Pulse Rate | 3 Beats per minute | Standard Deviation 9 |
| Sitagliptin 100 mg- Main Phase | Change in Pulse Rate | 0 Beats per minute | Standard Deviation 10 |
Secondary
Change in Pulse Rate- Sustainability
Change from baseline (week 0) in pulse rate was evaluated at week 104. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 104
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in Pulse Rate- Sustainability | 2 Beats per minute | Standard Deviation 9 |
Secondary
Change in Pulse Rate- Switch
Change from week 52 in pulse rate was evaluated at week 104. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 52, week 104
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in Pulse Rate- Switch | 1 Beats per minute | Standard Deviation 9 |
| Sitagliptin 100 mg- Main Phase | Change in Pulse Rate- Switch | -0 Beats per minute | Standard Deviation 10 |
Secondary
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)
SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at week 52. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.
Time frame: Week 0, week 52
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Physical functioning | 1.54 Score on a scale | Standard Deviation 7.92 |
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Role physical | 0.40 Score on a scale | Standard Deviation 7.82 |
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Bodily pain | 1.09 Score on a scale | Standard Deviation 9.01 |
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | General health | 1.83 Score on a scale | Standard Deviation 7.65 |
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Vitality | 1.07 Score on a scale | Standard Deviation 8.16 |
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Social functioning | 0.38 Score on a scale | Standard Deviation 9 |
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Role emotional | -0.91 Score on a scale | Standard Deviation 11.71 |
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Mental health | 1.21 Score on a scale | Standard Deviation 8.54 |
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | PCS | 1.51 Score on a scale | Standard Deviation 6.39 |
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | MCS | 0.01 Score on a scale | Standard Deviation 8.75 |
| Sitagliptin 100 mg- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Mental health | 0.86 Score on a scale | Standard Deviation 7.97 |
| Sitagliptin 100 mg- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Physical functioning | -0.03 Score on a scale | Standard Deviation 7.16 |
| Sitagliptin 100 mg- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Social functioning | 0.41 Score on a scale | Standard Deviation 7.86 |
| Sitagliptin 100 mg- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Role physical | 0.13 Score on a scale | Standard Deviation 8.38 |
| Sitagliptin 100 mg- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | MCS | 0.26 Score on a scale | Standard Deviation 7.67 |
| Sitagliptin 100 mg- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Bodily pain | 1.20 Score on a scale | Standard Deviation 8.72 |
| Sitagliptin 100 mg- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Role emotional | -0.54 Score on a scale | Standard Deviation 10.58 |
| Sitagliptin 100 mg- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | General health | 1.62 Score on a scale | Standard Deviation 6.71 |
| Sitagliptin 100 mg- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | PCS | 0.74 Score on a scale | Standard Deviation 5.81 |
| Sitagliptin 100 mg- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Vitality | 0.51 Score on a scale | Standard Deviation 7.28 |
Secondary
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Sustainability
Short form (SF)-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at week 104. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.
Time frame: Week 0, week 104
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Sustainability | Physical functioning | 1.44 Score on a scale | Standard Deviation 8.48 |
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Sustainability | Role physical | 0.22 Score on a scale | Standard Deviation 8.31 |
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Sustainability | Bodily pain | 1.07 Score on a scale | Standard Deviation 9.72 |
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Sustainability | General health | 1.98 Score on a scale | Standard Deviation 8.01 |
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Sustainability | Vitality | 0.97 Score on a scale | Standard Deviation 8.49 |
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Sustainability | Social functioning | -0.11 Score on a scale | Standard Deviation 8.14 |
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Sustainability | Role emotional | -0.04 Score on a scale | Standard Deviation 10.49 |
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Sustainability | Mental health | 1.05 Score on a scale | Standard Deviation 8.25 |
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Sustainability | PCS | 1.33 Score on a scale | Standard Deviation 6.96 |
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Sustainability | MCS | 0.20 Score on a scale | Standard Deviation 8.34 |
Secondary
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch
SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from week 52 in the domain scores and component summary (PCS and MCS) scores were evaluated at week 104. A positive change score indicates an improvement since week 52. Results are based on the data from the in-trial observation period.
Time frame: Week 52, week 104
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch | Physical functioning | 1.14 Score on a scale | Standard Deviation 8.55 |
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch | Role physical | 1.37 Score on a scale | Standard Deviation 7.68 |
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch | Bodily pain | -0.18 Score on a scale | Standard Deviation 7.22 |
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch | General health | 0.69 Score on a scale | Standard Deviation 6.74 |
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch | Vitality | -0.18 Score on a scale | Standard Deviation 6.91 |
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch | Social functioning | 0.21 Score on a scale | Standard Deviation 7.36 |
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch | Role emotional | 1.72 Score on a scale | Standard Deviation 9.61 |
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch | Mental health | 0.37 Score on a scale | Standard Deviation 6.68 |
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch | PCS | 0.66 Score on a scale | Standard Deviation 6.06 |
| Oral Semaglutide Flex- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch | MCS | 0.52 Score on a scale | Standard Deviation 7.21 |
| Sitagliptin 100 mg- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch | Mental health | 0.20 Score on a scale | Standard Deviation 6.46 |
| Sitagliptin 100 mg- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch | Physical functioning | -0.97 Score on a scale | Standard Deviation 6.71 |
| Sitagliptin 100 mg- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch | Social functioning | 0.10 Score on a scale | Standard Deviation 6.54 |
| Sitagliptin 100 mg- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch | Role physical | -0.22 Score on a scale | Standard Deviation 7.61 |
| Sitagliptin 100 mg- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch | MCS | 0.19 Score on a scale | Standard Deviation 6.46 |
| Sitagliptin 100 mg- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch | Bodily pain | -0.30 Score on a scale | Standard Deviation 7.06 |
| Sitagliptin 100 mg- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch | Role emotional | -0.39 Score on a scale | Standard Deviation 8.79 |
| Sitagliptin 100 mg- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch | General health | 0.53 Score on a scale | Standard Deviation 6.59 |
| Sitagliptin 100 mg- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch | PCS | -0.43 Score on a scale | Standard Deviation 5.36 |
| Sitagliptin 100 mg- Main Phase | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch | Vitality | -0.15 Score on a scale | Standard Deviation 7.32 |
Secondary
Change in Total Cholesterol (Ratio to Baseline)
Change from baseline (week 0) in total cholesterol (mmol/L) at week 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, Week 52
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in Total Cholesterol (Ratio to Baseline) | 0.96 Ratio of total cholesterol | Geometric Coefficient of Variation 19.3 |
| Sitagliptin 100 mg- Main Phase | Change in Total Cholesterol (Ratio to Baseline) | 1.01 Ratio of total cholesterol | Geometric Coefficient of Variation 16.2 |
Secondary
Change in Triglycerides (Ratio to Baseline)
Change from baseline (week 0) in triglycerides (mmol/L) at week 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 52
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in Triglycerides (Ratio to Baseline) | 0.89 Ratio of triglycerides | Geometric Coefficient of Variation 38.2 |
| Sitagliptin 100 mg- Main Phase | Change in Triglycerides (Ratio to Baseline) | 0.91 Ratio of triglycerides | Geometric Coefficient of Variation 43.1 |
Secondary
Change in Waist Circumference
Change from baseline (week 0) in waist circumference was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 52
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in Waist Circumference | -2.6 Centimeters (cm) | Standard Deviation 5.3 |
| Sitagliptin 100 mg- Main Phase | Change in Waist Circumference | -0.7 Centimeters (cm) | Standard Deviation 5.1 |
Secondary
Change in Waist Circumference- Sustainability
Change from baseline (week 0) in waist circumference was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 104
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in Waist Circumference- Sustainability | -2.5 cm | Standard Deviation 6.3 |
Secondary
Change in Waist Circumference- Switch
Change from week 52 in waist circumference was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 52, week 104
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Change in Waist Circumference- Switch | -1.8 Centimeters (cm) | Standard Deviation 4.3 |
| Sitagliptin 100 mg- Main Phase | Change in Waist Circumference- Switch | -0.9 Centimeters (cm) | Standard Deviation 5.8 |
Secondary
Number of TEAEs During Exposure to Trial Product
Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period for participants who continued in the extension phase; 52-week treatment period plus the 5-week follow-up period for participants who did not continue in the extension phase). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0-57
Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Semaglutide Flex- Main Phase | Number of TEAEs During Exposure to Trial Product | 768 Events |
| Sitagliptin 100 mg- Main Phase | Number of TEAEs During Exposure to Trial Product | 519 Events |
Secondary
Number of TEAEs During Exposure to Trial Product- Sustainability
Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 109 ((104-week treatment period for participants who continued in the extension phase or 52-week treatment period for participants who did not continue in the extension phase) plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0-109
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Semaglutide Flex- Main Phase | Number of TEAEs During Exposure to Trial Product- Sustainability | 1157 Events |
Secondary
Number of TEAEs During Exposure to Trial Product- Switch
Treatment emergent adverse events (TEAEs) were recorded from week 53 to week 109. Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 53-109
Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Semaglutide Flex- Main Phase | Number of TEAEs During Exposure to Trial Product- Switch | 267 Events |
| Sitagliptin 100 mg- Main Phase | Number of TEAEs During Exposure to Trial Product- Switch | 225 Events |
Secondary
Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes
Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-57 (52-week treatment period for participants who continued in the extension phase; 52-week treatment period plus the 5-week follow-up period for participants who did not continue in the extension phase). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Time frame: Week 0-57
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Semaglutide Flex- Main Phase | Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | 34 Episodes |
| Sitagliptin 100 mg- Main Phase | Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | 22 Episodes |
Secondary
Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes)- Sustainability
Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-109 ((104-week treatment period for participants who continued in the extension phase or 52-week treatment period for participants who did not continue in the extension phase) plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Time frame: Week 0-109
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Semaglutide Flex- Main Phase | Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes)- Sustainability | 45 Episodes |
Secondary
Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes- Switch
Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 53 to 109. Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Time frame: Week 53-109
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Semaglutide Flex- Main Phase | Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes- Switch | 2 Episodes |
| Sitagliptin 100 mg- Main Phase | Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes- Switch | 12 Episodes |
Secondary
Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)
Participants who achieved HbA1c less than or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no) at week 52 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 52
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | Yes | 76 Participants |
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | No | 154 Participants |
| Sitagliptin 100 mg- Main Phase | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | Yes | 29 Participants |
| Sitagliptin 100 mg- Main Phase | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | No | 209 Participants |
Secondary
Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)- Sustainability
Participants who achieved HbA1c less than or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no) at week 104 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 104
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)- Sustainability | Yes | 63 Participants |
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)- Sustainability | No | 117 Participants |
Secondary
Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)- Switch
Participants who achieved HbA1c less than or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no) at week 104 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 104 (i.e., after 52 weeks of treatment in the extension phase)
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)- Switch | Yes | 28 Participants |
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)- Switch | No | 64 Participants |
| Sitagliptin 100 mg- Main Phase | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)- Switch | Yes | 11 Participants |
| Sitagliptin 100 mg- Main Phase | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)- Switch | No | 85 Participants |
Secondary
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target and no Need for Rescue Medication (Yes/no)- Switch
Participants who achieved HbA1c \<7.0% (American Diabetes Association (ADA) target) and no need for rescue medication (yes/no), was evaluated at week 104. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Time frame: Week 104 (i.e., after 52 weeks of treatment in the extension phase)
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target and no Need for Rescue Medication (Yes/no)- Switch | 41 Participants |
| Sitagliptin 100 mg- Main Phase | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target and no Need for Rescue Medication (Yes/no)- Switch | 23 Participants |
Secondary
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target or HbA1c Reduction ≥ 1%-Point (10.9 mmol/Mol) (Yes/no)- Sustainability
Participants who achieved HbA1c \<7.0% ADA target or HbA1c reduction ≥ 1%-point (10.9 mmol/mol) (yes/no), was evaluated at week 104. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 104
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target or HbA1c Reduction ≥ 1%-Point (10.9 mmol/Mol) (Yes/no)- Sustainability | Yes | 126 Participants |
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target or HbA1c Reduction ≥ 1%-Point (10.9 mmol/Mol) (Yes/no)- Sustainability | No | 54 Participants |
Secondary
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)- Sustainability
Participants who achieved HbA1c \<7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at week 104. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 104
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)- Sustainability | Yes | 101 Participants |
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)- Sustainability | No | 79 Participants |
Secondary
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)- Switch
Participants who achieved HbA1c \<7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at week 104. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 104 (i.e., after 52 weeks of treatment in the extension phase)
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)- Switch | Yes | 44 Participants |
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)- Switch | No | 48 Participants |
| Sitagliptin 100 mg- Main Phase | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)- Switch | Yes | 26 Participants |
| Sitagliptin 100 mg- Main Phase | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)- Switch | No | 70 Participants |
Secondary
Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)
Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at week 52 is presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 52
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Yes | 104 Participants |
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | No | 126 Participants |
| Sitagliptin 100 mg- Main Phase | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Yes | 35 Participants |
| Sitagliptin 100 mg- Main Phase | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | No | 203 Participants |
Secondary
Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)- Sustainability
Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at week 104 is presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 104
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)- Sustainability | Yes | 73 Participants |
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)- Sustainability | No | 107 Participants |
Secondary
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)- Switch
Participants who achieved HbA1c less than 7.0% without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at week 104 is presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 104 (i.e., after 52 weeks of treatment in the extension phase)
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)- Switch | Yes | 36 Participants |
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)- Switch | No | 56 Participants |
| Sitagliptin 100 mg- Main Phase | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)- Switch | Yes | 18 Participants |
| Sitagliptin 100 mg- Main Phase | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)- Switch | No | 78 Participants |
Secondary
Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)
Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at week 52 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 52
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Yes | 80 Participants |
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | No | 150 Participants |
| Sitagliptin 100 mg- Main Phase | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Yes | 25 Participants |
| Sitagliptin 100 mg- Main Phase | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | No | 213 Participants |
Secondary
Participants Who Achieve Weight Loss ≥10% (Yes/no)
Participants who achieved weight loss more than or equal to 10% of their baseline body weight (yes/no) at week 52 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 52
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve Weight Loss ≥10% (Yes/no) | Yes | 15 Participants |
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve Weight Loss ≥10% (Yes/no) | No | 218 Participants |
| Sitagliptin 100 mg- Main Phase | Participants Who Achieve Weight Loss ≥10% (Yes/no) | Yes | 5 Participants |
| Sitagliptin 100 mg- Main Phase | Participants Who Achieve Weight Loss ≥10% (Yes/no) | No | 234 Participants |
Secondary
Participants Who Achieve Weight Loss ≥5% (Yes/no)
Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 52 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 52
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Yes | 63 Participants |
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve Weight Loss ≥5% (Yes/no) | No | 170 Participants |
| Sitagliptin 100 mg- Main Phase | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Yes | 29 Participants |
| Sitagliptin 100 mg- Main Phase | Participants Who Achieve Weight Loss ≥5% (Yes/no) | No | 210 Participants |
Secondary
Participants Who Achieve Weight Loss ≥5% (Yes/no)- Sustainability
Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 104 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 104
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve Weight Loss ≥5% (Yes/no)- Sustainability | Yes | 61 Participants |
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve Weight Loss ≥5% (Yes/no)- Sustainability | No | 119 Participants |
Secondary
Participants Who Achieve Weight Loss ≥5% (Yes/no)- Switch
Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 104 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 104 (i.e., after 52 weeks of treatment in the extension phase)
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve Weight Loss ≥5% (Yes/no)- Switch | Yes | 31 Participants |
| Oral Semaglutide Flex- Main Phase | Participants Who Achieve Weight Loss ≥5% (Yes/no)- Switch | No | 62 Participants |
| Sitagliptin 100 mg- Main Phase | Participants Who Achieve Weight Loss ≥5% (Yes/no)- Switch | No | 85 Participants |
| Sitagliptin 100 mg- Main Phase | Participants Who Achieve Weight Loss ≥5% (Yes/no)- Switch | Yes | 12 Participants |
Secondary
Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)
Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-57 (52-week treatment period for participants who continued in the extension phase; 52-week treatment period plus the 5-week follow-up period for participants who did not continue in the extension phase). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Time frame: Week 0-57
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide Flex- Main Phase | Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no) | 14 Participants |
| Sitagliptin 100 mg- Main Phase | Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no) | 14 Participants |
Secondary
Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)- Sustainability
Number of participants with treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-109 ((104-week treatment period for participants who continued in the extension phase or 52-week treatment period for participants who did not continue in the extension phase) plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Time frame: Week 0-109
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide Flex- Main Phase | Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)- Sustainability | 18 Participants |
Secondary
Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)- Switch
Number of participants with treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 53 to 109. Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Time frame: Week 53-109
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide Flex- Main Phase | Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)- Switch | 2 Participants |
| Sitagliptin 100 mg- Main Phase | Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)- Switch | 4 Participants |
Secondary
Time to Additional Anti-diabetic Medication
Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the period from week 0 to week 52. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 52), 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 randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Weeks 0-52
Population: Overall number of participants analyzed = FAS which comprised all randomised participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide Flex- Main Phase | Time to Additional Anti-diabetic Medication | 22 Participants |
| Sitagliptin 100 mg- Main Phase | Time to Additional Anti-diabetic Medication | 47 Participants |
Comparison: Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before planned end of treatment.p-value: 0.017595% CI: [0.37, 0.91]Regression, Cox
Secondary
Time to Additional Anti-diabetic Medication- Switch
Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the period from week 53 to week 104. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after re-randomisation (week 52) and before (planned) end-of-treatment (week 104), 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 randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Weeks 53-104
Population: Overall number of participants analyzed = FAS which comprised all randomised participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide Flex- Main Phase | Time to Additional Anti-diabetic Medication- Switch | 15 Participants |
| Sitagliptin 100 mg- Main Phase | Time to Additional Anti-diabetic Medication- Switch | 26 Participants |
Comparison: Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before planned end of treatment.p-value: 0.438195% CI: [0.39, 1.5]Regression, Cox
Secondary
Time to Rescue Medication
Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 52. 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 randomisation (week 0) 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 randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Time frame: Weeks 0-52
Population: Overall number of participants analyzed = FAS which comprised all randomised participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide Flex- Main Phase | Time to Rescue Medication | 8 Participants |
| Sitagliptin 100 mg- Main Phase | Time to Rescue Medication | 40 Participants |
Comparison: Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.p-value: <0.000195% CI: [0.09, 0.39]Regression, Cox
Secondary
Time to Rescue Medication- Switch
Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 53 to week 104. 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 re-randomisation (week 52) 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 randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Time frame: Weeks 53-104
Population: Overall number of participants analyzed = FAS which comprised all randomised participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide Flex- Main Phase | Time to Rescue Medication- Switch | 9 Participants |
| Sitagliptin 100 mg- Main Phase | Time to Rescue Medication- Switch | 23 Participants |
Comparison: Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.p-value: 0.07995% CI: [0.2, 1.09]Regression, Cox