Percentage of Participants Who Achieved HbA1C <7% at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)
Time frame · Baseline (result closest prior to dosing on Day 1), Week 32
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)
Time frame · Baseline (result closest prior to dosing on Day 1), Week 32
Percent Change From Baseline in Body Weight at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)
Time frame · Baseline (result closest prior to dosing on Day 1), Week 32
Registry description
Body weight was measured using a calibrated weighing scale.
Placebo-adjusted, Change From Baseline in HbA1C in the Rybelsus Arm at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)
Time frame · Baseline (result closest prior to dosing on Day 1), Week 32
Registry description
This outcome measure was planned to be analyzed only for rybelsus arm and placebo arm as pre-specified in the protocol.
Percentage of Participants Achieving >=5%, >=10%, and >=15% Body Weight Loss at Week 32 Relative to Baseline: Cohort 2 (Obesity)
Time frame · Baseline (result closest prior to dosing on Day 1), Week 32
Absolute Change From Baseline in Waist Circumference at Week 32: Cohort 2 (Obesity)
Time frame · Baseline (result closest prior to dosing on Day 1), Week 32
Registry description
Waist circumference was measured at midpoint, between lower margin of last palpable rib and top of iliac crest (approximately 1 inch \[2.54 centimeter {cm}\] above the navel). It was measured by using an anthropometric tape (stretch-resistant).
Absolute Change From Baseline in Waist-to-hip Ratio at Week 32: Cohort 2 (Obesity)
Time frame · Baseline (result closest prior to dosing on Day 1), Week 32
Registry description
The hip circumference was defined as the circumference around the widest portion of the buttocks. Waist circumference was measured at midpoint, between lower margin of last palpable rib and top of iliac crest (approximately 1 inch \[2.54 cm\] above the navel). The measurements were performed using an anthropometric tape (stretch-resistant).
Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at Week 32: Cohort 2 (Obesity)
Time frame · Baseline (result closest prior to dosing on Day 1), Week 32
Registry description
HOMA-IR was calculated as: fasting plasma insulin (\[FPI\]\*(FPG)/405 and measured in terms of mg/dL\* (milliunits per liter).
Change From Baseline in Homeostatic Model Assessment for Insulin Sensitivity (HOMA-S) at Week 32: Cohort 2 (Obesity)
Time frame · Baseline (result closest prior to dosing on Day 1), Week 32
Registry description
HOMA-S was calculated as (22.5/\[FPI\] \* FPG) \*100 and measured in terms of percentage sensitivity.
Number of Participants With Treatment Emergent Adverse Events (TEAEs): Cohort 1 (Type 2 Diabetes Mellitus)
Time frame · From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)
Registry description
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were any AEs that occurred on or after the first dose of treatment but before the last dose plus lag time.
Number of Participants With Treatment Emergent Adverse Events (TEAEs): Cohort 2 (Obesity)
Time frame · From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)
Registry description
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were any AEs that occurred on or after the first dose of treatment but before the last dose plus lag time.
Number of Participants With Serious Adverse Events (SAEs): Cohort 1 (Type 2 Diabetes Mellitus)
Time frame · From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)
Registry description
SAE defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic; other important medical events.
Number of Participants With Serious Adverse Events (SAEs): Cohort 2 (Obesity)
Time frame · From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)
Registry description
SAE defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic; other important medical events.
Number of Participants Reporting Adverse Events Leading to Permanent Discontinuation From Study Treatment and Study: Cohort 1 (Type 2 Diabetes Mellitus)
Time frame · From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)
Registry description
\\ An AE was any untoward medical occurrence in a participants or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs leading to permanent discontinuation from study were those with an AE record indicating the AE caused permanent discontinuation from the study. AEs leading to permanent discontinuation from study treatment were those AEs with an AE record indicating that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study.
Number of Participants Reporting Adverse Events Leading to Permanent Discontinuation From Study Treatment and Study: Cohort 2 (Obesity)
Time frame · From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)
Registry description
An AE was any untoward medical occurrence in a participants or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs leading to permanent discontinuation from study were those with an AE record indicating the AE caused permanent discontinuation from the study. AEs leading to permanent discontinuation from study treatment were those AEs with an AE record indicating that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study.
Number of Participants With Hypoglycemic Adverse Events (HAE) According to Titration Dose: Cohort 1 (Type 2 Diabetes Mellitus)
Time frame · Up to week 28
Registry description
Glucose values were monitored using glucometer. Hypoglycemia =plasma/blood glucose value of \<70 mg/dL (3.9 millimoles per liter \[mmol/L\]). Severe HAE: Participant was unable to treat him/herself due to neurological impairment (not age) and required assistance of another person, at least one neurological symptom of memory loss, confusion, uncontrolled behavior etc. Either documented blood glucose\<=54 mg/dL (2.7 mmol/L). Documented symptomatic: An event during which symptoms of HAE were accompanied with plasma/blood glucose \<70 mg/dL and prompt resolution with food intake, SC glucagon, or IV glucose. Probable symptomatic HAE: An event during which symptoms of an HAE were not accompanied by a plasma glucose determination but was presumably caused by a plasma glucose concentration \<70 mg/dL and prompt resolution with food intake, SC glucagon, or IV glucose. Asymptomatic: An event not accompanied by typical symptoms of an HAE, but a plasma/blood glucose value of \<70 mg/dL was reported.
Number of Participants With Hypoglycemic Adverse Events According to Titration Dose: Cohort 2 (Obesity)
Time frame · Up to week 28
Registry description
Glucose values were monitored using glucometer. Hypoglycemia =plasma/blood glucose value of \<70 mg/dL (3.9 mmol/L). Severe HAE: Participant was unable to treat him/herself due to neurological impairment (not age) and required assistance of another person, at least one neurological symptom of memory loss, confusion, uncontrolled behavior etc. Either documented blood glucose\<=54 mg/dL (2.7 mmol/L). Documented symptomatic: An event during which symptoms of HAE were accompanied with plasma/blood glucose \<70 mg/dL u and prompt resolution with food intake, SC glucagon, or IV glucose. Probable symptomatic HAE: An event during which symptoms of an HAE were not accompanied by a plasma glucose determination but was presumably caused by a plasma glucose concentration \<70 mg/dL and prompt resolution with food intake, SC glucagon, or IV glucose. Asymptomatic: An event not accompanied by typical symptoms of an HAE, but a plasma/blood glucose value of \<70 mg/dL was reported.
Number of Participants With Vital Sign Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus)
Time frame · Up to week 28
Registry description
Vital signs included blood pressure and pulse rate and were measured with the participants in a seated position after at least 5 minutes of rest for the participant. Criteria for abnormalities included: Systolic Blood Pressure (millimeter of mercury \[mmHg\]): value more than (\>) 200 and value less than (\<) 90; Diastolic blood pressure: value \> 100 and \< 40; Pulse rate: (beats per minute \[BPM\]): value \< 40 and \> 110.
Number of Participants With Vital Sign Abnormalities: Cohort 2 (Obesity)
Time frame · Up to week 28
Registry description
Vital signs included blood pressure and pulse rate and were measured with the participants in a seated position after at least 5 minutes of rest for the participant. Criteria for abnormalities included: Systolic blood pressure (mmHg): value \> 200 and value \< 90; Diastolic blood pressure: value \> 100 and \< 40; Pulse rate: (BPM): value \< 40 and \> 110.
Number of Participants With Clinical Laboratory Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus)
Time frame · Up to week 28
Registry description
Hematology: platelets (10\^9/L)\< 0.5\*lower limit of normal (LLN); leukocytes\< 0.6\*LLN and \>1.5\*upper limit of normal (ULN); lymphocytes and neutrophils \<0.8\*LLN and \>1.2\*ULN; basophils, eosinophils, monocytes:\>1.2\*ULN; prothrombin time (sec) \>1.1\*ULN; prothrombin international normalized ratio \>1.1\*ULN; clinical chemistry: bilirubin (mg/dL), indirect bilirubin:\>1.5\*ULN; aspartate and alanine aminotransferase, gamma glutamyl transferase (U/L):\>3.0\*ULN; urea nitrogen and creatinine (mg/dL)\>1.3\* ULN;HDL cholesterol (mg/dL)\<0.8\*LLN; LDL (mg/dL)\>1.2\*ULN, Triglycerides (mg/dL):\>1.3\*ULN; Potassium (milliequivalents per liter) \< 0.9\*LLN and \> 1.1\* ULN; calcium (mg/dL)\< 0.9\*LLN, Thyroxine (nanograms/dL\<0.8\*LLN and \>1.2\*ULN, HbA1C (%)\>1.3\*ULN; Amylase, Lipase (U/L) and Glucose -Fasting (mg/dL)\>1.5\*ULN; urinalysis: pH\> 8; urine glucose, ketones, protein, hemoglobin, nitrite and leukocyte esterase\>=1. Number of participants with abnormalities in any of the laboratory parameters is reported.