Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes.
Interventions
DRUGsemaglutide
Administered subcutaneously (s.c., under the skin) once-weekly.
DRUGDulaglutide
Administered subcutaneously (s.c., under the skin) once-weekly.
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
- Male or female, age at least 18 years at the time of signing informed consent. - HbA1c (glycosylated haemoglobin) 7.0 - 10.5% (53 - 91 mmol/mol) (both inclusive) - Subjects on stable diabetes treatment with metformin (minimum of 1500 mg/day or maximal tolerated dose documented in the patient medical record) for 90 days prior to screening
Exclusion criteria
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) - Any condition, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term insulin treatment for acute illness for a total of equal to or below 14 days - History of pancreatitis (acute or chronic) - Screening calcitonin equal to or above 50 ng/L - Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma - Renal impairment defined as eGFR (electronic case report form) below 60 mL/min/1.73 m\^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) - Subjects presently classified as being in New York Heart Association Class IV - Planned coronary, carotid or peripheral artery revascularisation on the day of screening - Proliferative retinopathy or maculopathy requiring acute treatment - History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas) - Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on a frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | Week 0, week 40 | Results are based on HbA1c data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on-treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fasting Plasma Glucose | Week 0, week 40 | Results are based on fasting plasma glucose data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. |
| Change in Systolic and Diastolic Blood Pressure | Week 0, week 40 | Results are based on systolic and diastolic blood pressure data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. |
| Change in Overall Scores for Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire | Week 0, week 40 | The questionnaire contains 8 items and evaluates subjects' diabetes treatment in terms of convenience, flexibility and general feelings towards treatment. The result presented is 'Treatment Satisfaction' summary score (sum of 6 of the 8 items). Response options: 6 (best case) to 0 (worst case). Total scores range: 0-36. Higher scores=higher satisfaction. Results are based on data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This includes observations recorded at, or after the date of first dose of trial product and not after first occurrence of following: the end-date of the 'on-treatment' observation period or initiation of rescue medication |
| HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target | After 40 weeks treatment | Percentage of subjects who achieved HbA1c target below or equal to 6.5% (48 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. |
| Change From Baseline in 7-point Self-measured Plasma Glucose (SMPG) Mean Profile | Week 0, week 40 | SMPG values were recorded at 7 time-points: before and 90 minutes after start of breakfast, lunch, and dinner, and at bedtime. Reported results are mean profile from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. |
| Change From Baseline 7-point Self-measured Plasma Glucose Increment | Week 0, week 40 | SMPG values were recorded at 7 time-points: before and 90 minutes after start of breakfast, lunch, and dinner, and at bedtime. Reported results are plasma glucose incremental profile from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes observations recorded at, or after date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit |
| Change in Fasting Blood Lipids (Total Cholesterol) | Week 0, week 40 | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value. |
| Change in Fasting Blood Lipids (Low Density Lipoprotein [LDL] Cholesterol) | Week 0, week 40 | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value. |
| Change in Fasting Blood Lipids (High Density Lipoprotein [HDL] Cholesterol) | Week 0, week 40 | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value. |
| Change in Fasting Blood Lipids (Triglycerides) | Week 0, week 40 | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value. |
| Change in Body Mass Index (BMI) | Week 0, week 40 | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. |
| Change in Waist Circumference | Week 0, week 40 | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. |
| Change in Short Form Health Survey (SF-36v2™) | Week 0, week 40 | The questionnaire contains 36 items across 8 domains and 2 summary scores. Score range: 0 (worst score) to 100 (best score). Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. |
| Change in Body Weight (kg) | Week 0, week 40 | Results are based on body weight data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. |
| Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥5% | After 40 weeks treatment | Percentage of subjects who achieved weight loss ≥5% after 40 weeks of treatment. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. |
| Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥10% | After 40 weeks treatment | Percentage of subjects who achieved weight loss ≥10% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. |
| Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain | After 40 weeks of treatment | Percentage of subjects achieved (yes/no) HbA1c \<7.0% (53 mmol/mol) without severe or BG confirmed symptomatic hypoglycaemia episodes and no weight gain after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was subset of 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit |
| Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% | After 40 weeks of treatment | Percentage of subjects who achieved (yes/no) HbA1c reduction of ≥1% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. |
| Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥3% | After 40 weeks treatment | Percentage of subjects who achieved (yes/no) weight loss of ≥3% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. |
| Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% and Weight Loss ≥3% | After 40 weeks treatment | Percentage of subjects who achieved (yes/no) HbA1c reduction ≥1% and weight loss ≥3% 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. |
| Number of Treatment Emergent Adverse Events (TEAEs) | 40 weeks + follow-up of 5 weeks | A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). |
| Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes | 40 weeks + follow-up of 5 weeks | A treatment emergent hypoglycaemic episode was defined as an episode with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association classification or BG-confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. |
| Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | 40 weeks + follow-up of 5 weeks | Percentage of subjects with treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes. A treatment emergent hypoglycaemic episode was defined as an episode with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association classification or BG-confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. |
| Change in Amylase | Week 0, week 40 | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value. |
| Change in Lipase | Week 0, week 40 | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value. |
| Change in Pulse Rate | Week 0, week 40 | Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. |
| Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target | After 40 weeks of treatment | Percentage of subjects who achieved HbA1c target below or equal to \<7.0% (53 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. |
Countries
Bulgaria, Croatia, Finland, Germany, Greece, Hong Kong, India, Ireland, Latvia, Lithuania, Portugal, Puerto Rico, Romania, Slovakia, Spain, United Kingdom, United States
Participant flow
Recruitment details
A total of 210 sites were approved for recruiting subjects, of which 196 sites randomized the subjects: Bulgaria: 6; Croatia: 6; Finland: 6; Germany: 6; Greece: 8; Hong Kong: 1; India: 22; Ireland: 5; Latvia: 3; Lithuania: 5; Portugal: 4; Romania: 7; Slovakia: 6; Spain: 8; United Kingdom: 8; United States: 95.
Participants by arm
| Arm | Count |
|---|---|
| Semaglutide 0.5 mg Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | 301 |
| Semaglutide 1.0 mg Subjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | 300 |
| Dulaglutide 0.75 mg Subjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | 299 |
| Dulaglutide 1.5 mg Subjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | 299 |
| Total | 1,199 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 |
| Overall Study | Death | 1 | 1 | 2 | 2 |
| Overall Study | Lost to Follow-up | 5 | 8 | 4 | 6 |
| Overall Study | Missing follow-up information | 4 | 4 | 4 | 2 |
| Overall Study | Withdrawal by Subject | 12 | 8 | 2 | 6 |
Baseline characteristics
| Characteristic | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Dulaglutide 0.75 mg | Dulaglutide 1.5 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 10.9 | 55 years STANDARD_DEVIATION 10.6 | 55 years STANDARD_DEVIATION 10.4 | 56 years STANDARD_DEVIATION 10.6 | 56 years STANDARD_DEVIATION 10.6 |
| Body weight | 96.4 kg STANDARD_DEVIATION 24.38 | 95.5 kg STANDARD_DEVIATION 20.9 | 95.6 kg STANDARD_DEVIATION 23.01 | 93.4 kg STANDARD_DEVIATION 21.79 | 95.2 kg STANDARD_DEVIATION 22.56 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 29 Participants | 35 Participants | 31 Participants | 43 Participants | 138 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 272 Participants | 265 Participants | 268 Participants | 256 Participants | 1061 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Fasting plasma glucose | 9.8 mmol/L STANDARD_DEVIATION 2.54 | 9.8 mmol/L STANDARD_DEVIATION 2.58 | 9.7 mmol/L STANDARD_DEVIATION 2.65 | 9.6 mmol/L STANDARD_DEVIATION 2.29 | 9.7 mmol/L STANDARD_DEVIATION 2.52 |
| Glycosylated haemoglobin (Hb1Ac) | 8.3 percentage of HbA1c STANDARD_DEVIATION 0.96 | 8.2 percentage of HbA1c STANDARD_DEVIATION 0.92 | 8.2 percentage of HbA1c STANDARD_DEVIATION 0.91 | 8.2 percentage of HbA1c STANDARD_DEVIATION 0.89 | 8.2 percentage of HbA1c STANDARD_DEVIATION 0.92 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 50 Participants | 38 Participants | 48 Participants | 55 Participants | 191 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 18 Participants | 17 Participants | 18 Participants | 70 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants | 6 Participants | 10 Participants |
| Race (NIH/OMB) White | 233 Participants | 243 Participants | 232 Participants | 220 Participants | 928 Participants |
| Sex: Female, Male Female | 169 Participants | 162 Participants | 160 Participants | 171 Participants | 662 Participants |
| Sex: Female, Male Male | 132 Participants | 138 Participants | 139 Participants | 128 Participants | 537 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 301 | 1 / 300 | 2 / 299 | 2 / 299 |
| other Total, other adverse events | 132 / 301 | 134 / 300 | 106 / 299 | 139 / 299 |
| serious Total, serious adverse events | 17 / 301 | 23 / 300 | 24 / 299 | 22 / 299 |
Outcome results
Primary
Change in HbA1c
Results are based on HbA1c data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on-treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Time frame: Week 0, week 40
Population: Analysis was based on FAS.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in HbA1c | -1.51 percentage of HbA1c | Standard Error 0.06 |
| Semaglutide 1.0 mg | Change in HbA1c | -1.78 percentage of HbA1c | Standard Error 0.06 |
| Dulaglutide 0.75 mg | Change in HbA1c | -1.11 percentage of HbA1c | Standard Error 0.05 |
| Dulaglutide 1.5 mg | Change in HbA1c | -1.37 percentage of HbA1c | Standard Error 0.06 |
p-value: <0.000195% CI: [-0.55, -0.25]Mixed Models Analysis
p-value: <0.000195% CI: [-0.55, -0.25]Mixed Models Analysis
p-value: <0.000195% CI: [-0.57, -0.25]Mixed Models Analysis
p-value: <0.000195% CI: [-0.57, -0.25]Mixed Models Analysis
Secondary
Change From Baseline 7-point Self-measured Plasma Glucose Increment
SMPG values were recorded at 7 time-points: before and 90 minutes after start of breakfast, lunch, and dinner, and at bedtime. Reported results are plasma glucose incremental profile from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes observations recorded at, or after date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit
Time frame: Week 0, week 40
Population: Analysis was based on FAS. Number of participants analysed=number of participants with available data for 7-point self-measured plasma glucose increment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change From Baseline 7-point Self-measured Plasma Glucose Increment | -0.77 mmol/L | Standard Error 0.08 |
| Semaglutide 1.0 mg | Change From Baseline 7-point Self-measured Plasma Glucose Increment | -0.93 mmol/L | Standard Error 0.09 |
| Dulaglutide 0.75 mg | Change From Baseline 7-point Self-measured Plasma Glucose Increment | -0.44 mmol/L | Standard Error 0.08 |
| Dulaglutide 1.5 mg | Change From Baseline 7-point Self-measured Plasma Glucose Increment | -0.63 mmol/L | Standard Error 0.08 |
Secondary
Change From Baseline in 7-point Self-measured Plasma Glucose (SMPG) Mean Profile
SMPG values were recorded at 7 time-points: before and 90 minutes after start of breakfast, lunch, and dinner, and at bedtime. Reported results are mean profile from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Time frame: Week 0, week 40
Population: Analysis was based on FAS. Number of participants analysed=Number of participants analysed=number of participants with available data for 7-point self-measured plasma glucose.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change From Baseline in 7-point Self-measured Plasma Glucose (SMPG) Mean Profile | -2.43 mmol/L | Standard Error 0.1 |
| Semaglutide 1.0 mg | Change From Baseline in 7-point Self-measured Plasma Glucose (SMPG) Mean Profile | -2.95 mmol/L | Standard Error 0.1 |
| Dulaglutide 0.75 mg | Change From Baseline in 7-point Self-measured Plasma Glucose (SMPG) Mean Profile | -1.99 mmol/L | Standard Error 0.1 |
| Dulaglutide 1.5 mg | Change From Baseline in 7-point Self-measured Plasma Glucose (SMPG) Mean Profile | -2.32 mmol/L | Standard Error 0.1 |
Secondary
Change in Amylase
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.
Time frame: Week 0, week 40
Population: Analysis was based on safety analysis set. Number of participants analysed=number of participants with available data for amylase.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Amylase | 1.17 ratio to baseline | Standard Error 0.02 |
| Semaglutide 1.0 mg | Change in Amylase | 1.22 ratio to baseline | Standard Error 0.02 |
| Dulaglutide 0.75 mg | Change in Amylase | 1.16 ratio to baseline | Standard Error 0.02 |
| Dulaglutide 1.5 mg | Change in Amylase | 1.20 ratio to baseline | Standard Error 0.02 |
Secondary
Change in Body Mass Index (BMI)
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Time frame: Week 0, week 40
Population: Analysis was based on FAS. Number of participants analysed=number of participants with available data for BMI.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Body Mass Index (BMI) | -1.63 kg/m^2 | Standard Error 0.1 |
| Semaglutide 1.0 mg | Change in Body Mass Index (BMI) | -2.33 kg/m^2 | Standard Error 0.1 |
| Dulaglutide 0.75 mg | Change in Body Mass Index (BMI) | -0.82 kg/m^2 | Standard Error 0.1 |
| Dulaglutide 1.5 mg | Change in Body Mass Index (BMI) | -1.08 kg/m^2 | Standard Error 0.1 |
Secondary
Change in Body Weight (kg)
Results are based on body weight data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication.
Time frame: Week 0, week 40
Population: Analysis was based on FAS. Number of subjects analysed=number of subjects with available data for body weight.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Body Weight (kg) | -4.56 kg | Standard Error 0.28 |
| Semaglutide 1.0 mg | Change in Body Weight (kg) | -6.53 kg | Standard Error 0.28 |
| Dulaglutide 0.75 mg | Change in Body Weight (kg) | -2.30 kg | Standard Error 0.27 |
| Dulaglutide 1.5 mg | Change in Body Weight (kg) | -2.98 kg | Standard Error 0.27 |
p-value: <0.000195% CI: [-3.02, -1.51]Mixed Models Analysis
p-value: <0.000195% CI: [-4.32, -2.78]Mixed Models Analysis
Secondary
Change in Fasting Blood Lipids (High Density Lipoprotein [HDL] Cholesterol)
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.
Time frame: Week 0, week 40
Population: Analysis was based on FAS. Number of participants analysed=number of participants with available data for HDL cholesterol.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Fasting Blood Lipids (High Density Lipoprotein [HDL] Cholesterol) | 0.99 ratio to baseline | Standard Error 0.01 |
| Semaglutide 1.0 mg | Change in Fasting Blood Lipids (High Density Lipoprotein [HDL] Cholesterol) | 1.01 ratio to baseline | Standard Error 0.01 |
| Dulaglutide 0.75 mg | Change in Fasting Blood Lipids (High Density Lipoprotein [HDL] Cholesterol) | 1.00 ratio to baseline | Standard Error 0.01 |
| Dulaglutide 1.5 mg | Change in Fasting Blood Lipids (High Density Lipoprotein [HDL] Cholesterol) | 1.02 ratio to baseline | Standard Error 0.01 |
Secondary
Change in Fasting Blood Lipids (Low Density Lipoprotein [LDL] Cholesterol)
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.
Time frame: Week 0, week 40
Population: Analysis was based on FAS. Number of participants analysed=number of participants with available data for LDL cholesterol.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Fasting Blood Lipids (Low Density Lipoprotein [LDL] Cholesterol) | 0.97 ratio to baseline | Standard Error 0.02 |
| Semaglutide 1.0 mg | Change in Fasting Blood Lipids (Low Density Lipoprotein [LDL] Cholesterol) | 1.00 ratio to baseline | Standard Error 0.02 |
| Dulaglutide 0.75 mg | Change in Fasting Blood Lipids (Low Density Lipoprotein [LDL] Cholesterol) | 0.97 ratio to baseline | Standard Error 0.02 |
| Dulaglutide 1.5 mg | Change in Fasting Blood Lipids (Low Density Lipoprotein [LDL] Cholesterol) | 1.01 ratio to baseline | Standard Error 0.02 |
Secondary
Change in Fasting Blood Lipids (Total Cholesterol)
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.
Time frame: Week 0, week 40
Population: Analysis was based on FAS. Number of participants analysed=number of participants with available data for total cholesterol
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Fasting Blood Lipids (Total Cholesterol) | 0.96 ratio to baseline | Standard Error 0.01 |
| Semaglutide 1.0 mg | Change in Fasting Blood Lipids (Total Cholesterol) | 0.97 ratio to baseline | Standard Error 0.01 |
| Dulaglutide 0.75 mg | Change in Fasting Blood Lipids (Total Cholesterol) | 0.97 ratio to baseline | Standard Error 0.01 |
| Dulaglutide 1.5 mg | Change in Fasting Blood Lipids (Total Cholesterol) | 0.99 ratio to baseline | Standard Error 0.01 |
Secondary
Change in Fasting Blood Lipids (Triglycerides)
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.
Time frame: Week 0, week 40
Population: Analysis was based on FAS. Number of participants analysed=number of participants with available data for triglycerides.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Fasting Blood Lipids (Triglycerides) | 0.91 ratio to baseline | Standard Error 0.02 |
| Semaglutide 1.0 mg | Change in Fasting Blood Lipids (Triglycerides) | 0.86 ratio to baseline | Standard Error 0.02 |
| Dulaglutide 0.75 mg | Change in Fasting Blood Lipids (Triglycerides) | 0.91 ratio to baseline | Standard Error 0.02 |
| Dulaglutide 1.5 mg | Change in Fasting Blood Lipids (Triglycerides) | 0.90 ratio to baseline | Standard Error 0.02 |
Secondary
Change in Fasting Plasma Glucose
Results are based on fasting plasma glucose data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication.
Time frame: Week 0, week 40
Population: Analysis was based on FAS. Number of participants analysed=number of participants with available data for fasting plasma glucose.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Fasting Plasma Glucose | -2.18 mmol/L | Standard Error 0.12 |
| Semaglutide 1.0 mg | Change in Fasting Plasma Glucose | -2.83 mmol/L | Standard Error 0.12 |
| Dulaglutide 0.75 mg | Change in Fasting Plasma Glucose | -1.87 mmol/L | Standard Error 0.12 |
| Dulaglutide 1.5 mg | Change in Fasting Plasma Glucose | -2.25 mmol/L | Standard Error 0.12 |
Secondary
Change in Lipase
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.
Time frame: Week 0, week 40
Population: Analysis was based on safety analysis set. Number of participants analysed=number of participants with available data for lipase.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Lipase | 1.22 ratio to baseline | Standard Error 0.04 |
| Semaglutide 1.0 mg | Change in Lipase | 1.32 ratio to baseline | Standard Error 0.04 |
| Dulaglutide 0.75 mg | Change in Lipase | 1.23 ratio to baseline | Standard Error 0.04 |
| Dulaglutide 1.5 mg | Change in Lipase | 1.29 ratio to baseline | Standard Error 0.04 |
Secondary
Change in Overall Scores for Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire
The questionnaire contains 8 items and evaluates subjects' diabetes treatment in terms of convenience, flexibility and general feelings towards treatment. The result presented is 'Treatment Satisfaction' summary score (sum of 6 of the 8 items). Response options: 6 (best case) to 0 (worst case). Total scores range: 0-36. Higher scores=higher satisfaction. Results are based on data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This includes observations recorded at, or after the date of first dose of trial product and not after first occurrence of following: the end-date of the 'on-treatment' observation period or initiation of rescue medication
Time frame: Week 0, week 40
Population: Analysis was based on FAS. Number of participants analysed=number of participants with available data for diabetes treatment satisfaction questionnaire
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Overall Scores for Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire | 4.60 units on a scale | Standard Error 0.28 |
| Semaglutide 1.0 mg | Change in Overall Scores for Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire | 4.55 units on a scale | Standard Error 0.29 |
| Dulaglutide 0.75 mg | Change in Overall Scores for Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire | 4.52 units on a scale | Standard Error 0.28 |
| Dulaglutide 1.5 mg | Change in Overall Scores for Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire | 4.65 units on a scale | Standard Error 0.28 |
Secondary
Change in Pulse Rate
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Time frame: Week 0, week 40
Population: Analysis was based on safety analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Pulse Rate | 2.09 beats/min | Standard Error 0.51 |
| Semaglutide 1.0 mg | Change in Pulse Rate | 3.96 beats/min | Standard Error 0.51 |
| Dulaglutide 0.75 mg | Change in Pulse Rate | 1.56 beats/min | Standard Error 0.49 |
| Dulaglutide 1.5 mg | Change in Pulse Rate | 2.42 beats/min | Standard Error 0.5 |
Secondary
Change in Short Form Health Survey (SF-36v2™)
The questionnaire contains 36 items across 8 domains and 2 summary scores. Score range: 0 (worst score) to 100 (best score). Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Time frame: Week 0, week 40
Population: Analysis was based on FAS. Number analysed=number of participants with available data for SF-36.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Semaglutide 0.5 mg | Change in Short Form Health Survey (SF-36v2™) | Physical component summary | 1.21 units on a scale | Standard Error 0.4 |
| Semaglutide 0.5 mg | Change in Short Form Health Survey (SF-36v2™) | Mental component summary | 1.45 units on a scale | Standard Error 0.49 |
| Semaglutide 0.5 mg | Change in Short Form Health Survey (SF-36v2™) | Physical functioning | 1.25 units on a scale | Standard Error 0.44 |
| Semaglutide 0.5 mg | Change in Short Form Health Survey (SF-36v2™) | Role-physical | 0.98 units on a scale | Standard Error 0.48 |
| Semaglutide 0.5 mg | Change in Short Form Health Survey (SF-36v2™) | Bodily pain | 0.96 units on a scale | Standard Error 0.52 |
| Semaglutide 0.5 mg | Change in Short Form Health Survey (SF-36v2™) | General health | 2.65 units on a scale | Standard Error 0.43 |
| Semaglutide 0.5 mg | Change in Short Form Health Survey (SF-36v2™) | Vitality | 1.23 units on a scale | Standard Error 0.5 |
| Semaglutide 0.5 mg | Change in Short Form Health Survey (SF-36v2™) | Social functioning | 1.18 units on a scale | Standard Error 0.49 |
| Semaglutide 0.5 mg | Change in Short Form Health Survey (SF-36v2™) | Role-emotional | 1.11 units on a scale | Standard Error 0.57 |
| Semaglutide 0.5 mg | Change in Short Form Health Survey (SF-36v2™) | Mental health | 1.89 units on a scale | Standard Error 0.49 |
| Semaglutide 1.0 mg | Change in Short Form Health Survey (SF-36v2™) | Physical functioning | 2.00 units on a scale | Standard Error 0.44 |
| Semaglutide 1.0 mg | Change in Short Form Health Survey (SF-36v2™) | Role-emotional | 1.57 units on a scale | Standard Error 0.58 |
| Semaglutide 1.0 mg | Change in Short Form Health Survey (SF-36v2™) | Role-physical | 2.03 units on a scale | Standard Error 0.48 |
| Semaglutide 1.0 mg | Change in Short Form Health Survey (SF-36v2™) | Bodily pain | 1.54 units on a scale | Standard Error 0.52 |
| Semaglutide 1.0 mg | Change in Short Form Health Survey (SF-36v2™) | General health | 2.52 units on a scale | Standard Error 0.43 |
| Semaglutide 1.0 mg | Change in Short Form Health Survey (SF-36v2™) | Vitality | 1.97 units on a scale | Standard Error 0.5 |
| Semaglutide 1.0 mg | Change in Short Form Health Survey (SF-36v2™) | Mental health | 1.65 units on a scale | Standard Error 0.49 |
| Semaglutide 1.0 mg | Change in Short Form Health Survey (SF-36v2™) | Social functioning | 0.83 units on a scale | Standard Error 0.49 |
| Semaglutide 1.0 mg | Change in Short Form Health Survey (SF-36v2™) | Physical component summary | 2.04 units on a scale | Standard Error 0.4 |
| Semaglutide 1.0 mg | Change in Short Form Health Survey (SF-36v2™) | Mental component summary | 1.23 units on a scale | Standard Error 0.49 |
| Dulaglutide 0.75 mg | Change in Short Form Health Survey (SF-36v2™) | Social functioning | 0.78 units on a scale | Standard Error 0.48 |
| Dulaglutide 0.75 mg | Change in Short Form Health Survey (SF-36v2™) | Vitality | 2.14 units on a scale | Standard Error 0.49 |
| Dulaglutide 0.75 mg | Change in Short Form Health Survey (SF-36v2™) | Mental health | 1.43 units on a scale | Standard Error 0.48 |
| Dulaglutide 0.75 mg | Change in Short Form Health Survey (SF-36v2™) | Physical component summary | 1.93 units on a scale | Standard Error 0.39 |
| Dulaglutide 0.75 mg | Change in Short Form Health Survey (SF-36v2™) | Role-physical | 1.39 units on a scale | Standard Error 0.47 |
| Dulaglutide 0.75 mg | Change in Short Form Health Survey (SF-36v2™) | General health | 1.86 units on a scale | Standard Error 0.42 |
| Dulaglutide 0.75 mg | Change in Short Form Health Survey (SF-36v2™) | Role-emotional | 1.04 units on a scale | Standard Error 0.56 |
| Dulaglutide 0.75 mg | Change in Short Form Health Survey (SF-36v2™) | Mental component summary | 0.95 units on a scale | Standard Error 0.48 |
| Dulaglutide 0.75 mg | Change in Short Form Health Survey (SF-36v2™) | Bodily pain | 1.69 units on a scale | Standard Error 0.51 |
| Dulaglutide 0.75 mg | Change in Short Form Health Survey (SF-36v2™) | Physical functioning | 2.17 units on a scale | Standard Error 0.43 |
| Dulaglutide 1.5 mg | Change in Short Form Health Survey (SF-36v2™) | Bodily pain | 0.77 units on a scale | Standard Error 0.51 |
| Dulaglutide 1.5 mg | Change in Short Form Health Survey (SF-36v2™) | Social functioning | 0.63 units on a scale | Standard Error 0.48 |
| Dulaglutide 1.5 mg | Change in Short Form Health Survey (SF-36v2™) | General health | 2.73 units on a scale | Standard Error 0.42 |
| Dulaglutide 1.5 mg | Change in Short Form Health Survey (SF-36v2™) | Mental health | 0.96 units on a scale | Standard Error 0.48 |
| Dulaglutide 1.5 mg | Change in Short Form Health Survey (SF-36v2™) | Vitality | 1.83 units on a scale | Standard Error 0.5 |
| Dulaglutide 1.5 mg | Change in Short Form Health Survey (SF-36v2™) | Mental component summary | 1.08 units on a scale | Standard Error 0.48 |
| Dulaglutide 1.5 mg | Change in Short Form Health Survey (SF-36v2™) | Physical functioning | 1.05 units on a scale | Standard Error 0.43 |
| Dulaglutide 1.5 mg | Change in Short Form Health Survey (SF-36v2™) | Role-physical | 0.82 units on a scale | Standard Error 0.47 |
| Dulaglutide 1.5 mg | Change in Short Form Health Survey (SF-36v2™) | Physical component summary | 1.29 units on a scale | Standard Error 0.39 |
| Dulaglutide 1.5 mg | Change in Short Form Health Survey (SF-36v2™) | Role-emotional | 1.08 units on a scale | Standard Error 0.57 |
Secondary
Change in Systolic and Diastolic Blood Pressure
Results are based on systolic and diastolic blood pressure data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication.
Time frame: Week 0, week 40
Population: Analysis was based on FAS.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Semaglutide 0.5 mg | Change in Systolic and Diastolic Blood Pressure | Systolic BP | -2.44 mmHg | Standard Error 0.76 |
| Semaglutide 0.5 mg | Change in Systolic and Diastolic Blood Pressure | Diastolic BP | -0.57 mmHg | Standard Error 0.48 |
| Semaglutide 1.0 mg | Change in Systolic and Diastolic Blood Pressure | Diastolic BP | -2.05 mmHg | Standard Error 0.49 |
| Semaglutide 1.0 mg | Change in Systolic and Diastolic Blood Pressure | Systolic BP | -4.88 mmHg | Standard Error 0.77 |
| Dulaglutide 0.75 mg | Change in Systolic and Diastolic Blood Pressure | Diastolic BP | -0.35 mmHg | Standard Error 0.47 |
| Dulaglutide 0.75 mg | Change in Systolic and Diastolic Blood Pressure | Systolic BP | -2.16 mmHg | Standard Error 0.75 |
| Dulaglutide 1.5 mg | Change in Systolic and Diastolic Blood Pressure | Systolic BP | -2.86 mmHg | Standard Error 0.75 |
| Dulaglutide 1.5 mg | Change in Systolic and Diastolic Blood Pressure | Diastolic BP | -0.03 mmHg | Standard Error 0.47 |
Secondary
Change in Waist Circumference
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Time frame: Week 0, week 40
Population: Analysis was based on FAS. Number of participants analysed=number of participants with available data for waist circumference.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Waist Circumference | -4.27 cm | Standard Error 0.34 |
| Semaglutide 1.0 mg | Change in Waist Circumference | -5.20 cm | Standard Error 0.34 |
| Dulaglutide 0.75 mg | Change in Waist Circumference | -2.36 cm | Standard Error 0.33 |
| Dulaglutide 1.5 mg | Change in Waist Circumference | -2.93 cm | Standard Error 0.33 |
Secondary
HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target
Percentage of subjects who achieved HbA1c target below or equal to 6.5% (48 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Time frame: After 40 weeks treatment
Population: Results are based on the FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 0.5 mg | HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target | Yes | 49.2 percentage of subjects |
| Semaglutide 0.5 mg | HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target | No | 50.8 percentage of subjects |
| Semaglutide 1.0 mg | HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target | No | 33.3 percentage of subjects |
| Semaglutide 1.0 mg | HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target | Yes | 66.7 percentage of subjects |
| Dulaglutide 0.75 mg | HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target | Yes | 34.1 percentage of subjects |
| Dulaglutide 0.75 mg | HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target | No | 65.9 percentage of subjects |
| Dulaglutide 1.5 mg | HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target | Yes | 47.2 percentage of subjects |
| Dulaglutide 1.5 mg | HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target | No | 52.8 percentage of subjects |
Secondary
Number of Treatment Emergent Adverse Events (TEAEs)
A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days).
Time frame: 40 weeks + follow-up of 5 weeks
Population: Analysis was based on the safety analysis set which included all randomised subjects exposed to at least one dose of trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 0.5 mg | Number of Treatment Emergent Adverse Events (TEAEs) | 966 events |
| Semaglutide 1.0 mg | Number of Treatment Emergent Adverse Events (TEAEs) | 1015 events |
| Dulaglutide 0.75 mg | Number of Treatment Emergent Adverse Events (TEAEs) | 802 events |
| Dulaglutide 1.5 mg | Number of Treatment Emergent Adverse Events (TEAEs) | 957 events |
Secondary
Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes
A treatment emergent hypoglycaemic episode was defined as an episode with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association classification or BG-confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Time frame: 40 weeks + follow-up of 5 weeks
Population: Analysis was based on the safety analysis set which included all randomised subjects exposed to at least one dose of trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 0.5 mg | Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes | 3 hypoglycaemic episodes |
| Semaglutide 1.0 mg | Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes | 7 hypoglycaemic episodes |
| Dulaglutide 0.75 mg | Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes | 3 hypoglycaemic episodes |
| Dulaglutide 1.5 mg | Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes | 5 hypoglycaemic episodes |
Secondary
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target
Percentage of subjects who achieved HbA1c target below or equal to \<7.0% (53 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Time frame: After 40 weeks of treatment
Population: Analysis was based on FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 0.5 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target | Yes | 68.4 percentage of subjects |
| Semaglutide 0.5 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target | No | 31.6 percentage of subjects |
| Semaglutide 1.0 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target | No | 21.3 percentage of subjects |
| Semaglutide 1.0 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target | Yes | 78.7 percentage of subjects |
| Dulaglutide 0.75 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target | Yes | 52.2 percentage of subjects |
| Dulaglutide 0.75 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target | No | 47.8 percentage of subjects |
| Dulaglutide 1.5 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target | Yes | 66.6 percentage of subjects |
| Dulaglutide 1.5 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target | No | 33.4 percentage of subjects |
Secondary
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain
Percentage of subjects achieved (yes/no) HbA1c \<7.0% (53 mmol/mol) without severe or BG confirmed symptomatic hypoglycaemia episodes and no weight gain after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was subset of 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit
Time frame: After 40 weeks of treatment
Population: Analysis was based on FAS. Number of participants analysed=number of participants with available data for this endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 0.5 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain | Yes | 64.5 percentage of subjects |
| Semaglutide 0.5 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain | No | 35.5 percentage of subjects |
| Semaglutide 1.0 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain | No | 26.0 percentage of subjects |
| Semaglutide 1.0 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain | Yes | 74.0 percentage of subjects |
| Dulaglutide 0.75 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain | Yes | 44.1 percentage of subjects |
| Dulaglutide 0.75 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain | No | 55.9 percentage of subjects |
| Dulaglutide 1.5 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain | Yes | 58.4 percentage of subjects |
| Dulaglutide 1.5 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain | No | 41.6 percentage of subjects |
Secondary
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1%
Percentage of subjects who achieved (yes/no) HbA1c reduction of ≥1% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Time frame: After 40 weeks of treatment
Population: Analysis was based on FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 0.5 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% | Yes | 77.4 percentage of subjects |
| Semaglutide 0.5 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% | No | 22.6 percentage of subjects |
| Semaglutide 1.0 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% | No | 16.7 percentage of subjects |
| Semaglutide 1.0 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% | Yes | 83.3 percentage of subjects |
| Dulaglutide 0.75 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% | Yes | 53.8 percentage of subjects |
| Dulaglutide 0.75 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% | No | 46.2 percentage of subjects |
| Dulaglutide 1.5 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% | Yes | 67.6 percentage of subjects |
| Dulaglutide 1.5 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% | No | 32.4 percentage of subjects |
Secondary
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% and Weight Loss ≥3%
Percentage of subjects who achieved (yes/no) HbA1c reduction ≥1% and weight loss ≥3% 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Time frame: After 40 weeks treatment
Population: Analysis was based on FAS. Number of participants analysed=number of participants with available data for HbA1c and body weight.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 0.5 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% and Weight Loss ≥3% | Yes | 53.2 percentage of subjects |
| Semaglutide 0.5 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% and Weight Loss ≥3% | No | 46.8 percentage of subjects |
| Semaglutide 1.0 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% and Weight Loss ≥3% | No | 31.7 percentage of subjects |
| Semaglutide 1.0 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% and Weight Loss ≥3% | Yes | 68.3 percentage of subjects |
| Dulaglutide 0.75 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% and Weight Loss ≥3% | Yes | 25.1 percentage of subjects |
| Dulaglutide 0.75 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% and Weight Loss ≥3% | No | 74.9 percentage of subjects |
| Dulaglutide 1.5 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% and Weight Loss ≥3% | Yes | 34.9 percentage of subjects |
| Dulaglutide 1.5 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% and Weight Loss ≥3% | No | 65.1 percentage of subjects |
Secondary
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥10%
Percentage of subjects who achieved weight loss ≥10% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Time frame: After 40 weeks treatment
Population: Analysis was based on FAS. Number of participants analysed=number of participants with available data for body weight
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 0.5 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥10% | Yes | 14.3 percentage of subjects |
| Semaglutide 0.5 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥10% | No | 85.7 percentage of subjects |
| Semaglutide 1.0 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥10% | No | 73.3 percentage of subjects |
| Semaglutide 1.0 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥10% | Yes | 26.7 percentage of subjects |
| Dulaglutide 0.75 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥10% | Yes | 3.3 percentage of subjects |
| Dulaglutide 0.75 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥10% | No | 96.7 percentage of subjects |
| Dulaglutide 1.5 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥10% | Yes | 7.7 percentage of subjects |
| Dulaglutide 1.5 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥10% | No | 92.3 percentage of subjects |
Secondary
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥3%
Percentage of subjects who achieved (yes/no) weight loss of ≥3% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Time frame: After 40 weeks treatment
Population: Analysis was based on FAS. Number of participants analysed=number of participants with available data for body weight
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 0.5 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥3% | Yes | 64.5 percentage of subjects |
| Semaglutide 0.5 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥3% | No | 35.5 percentage of subjects |
| Semaglutide 1.0 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥3% | No | 23.3 percentage of subjects |
| Semaglutide 1.0 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥3% | Yes | 76.7 percentage of subjects |
| Dulaglutide 0.75 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥3% | Yes | 36.5 percentage of subjects |
| Dulaglutide 0.75 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥3% | No | 63.5 percentage of subjects |
| Dulaglutide 1.5 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥3% | Yes | 44.6 percentage of subjects |
| Dulaglutide 1.5 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥3% | No | 55.4 percentage of subjects |
Secondary
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥5%
Percentage of subjects who achieved weight loss ≥5% after 40 weeks of treatment. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Time frame: After 40 weeks treatment
Population: Analysis was based on FAS. Number of participants analysed=number of participants with available data for body weight.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 0.5 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥5% | Yes | 43.9 percentage of subjects |
| Semaglutide 0.5 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥5% | No | 56.1 percentage of subjects |
| Semaglutide 1.0 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥5% | No | 37.0 percentage of subjects |
| Semaglutide 1.0 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥5% | Yes | 63.0 percentage of subjects |
| Dulaglutide 0.75 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥5% | Yes | 22.7 percentage of subjects |
| Dulaglutide 0.75 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥5% | No | 77.3 percentage of subjects |
| Dulaglutide 1.5 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥5% | Yes | 30.2 percentage of subjects |
| Dulaglutide 1.5 mg | Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥5% | No | 69.8 percentage of subjects |
Secondary
Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Percentage of subjects with treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes. A treatment emergent hypoglycaemic episode was defined as an episode with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association classification or BG-confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Time frame: 40 weeks + follow-up of 5 weeks
Population: Analysis was based on the safety analysis set which included all randomised subjects exposed to at least one dose of trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 0.5 mg | Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | 0.7 percentage of subjects |
| Semaglutide 1.0 mg | Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | 1.7 percentage of subjects |
| Dulaglutide 0.75 mg | Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | 1.0 percentage of subjects |
| Dulaglutide 1.5 mg | Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | 1.7 percentage of subjects |