Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Africa, North and South America, Asia and Europe. The purpose of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes.
Interventions
DRUGsemaglutide
Injected subcutaneously (under the skin) once weekly. Following 4 doses (4 weeks) of 0.25 mg semaglutide weekly subjects will receive 0.5 mg semaglutide weekly for 26 weeks.
DRUGinsulin glargine
Injected subcutaneously (under the skin) once daily. Subjects will start on 10 IU once daily and the dose will be adjusted according to fasting plasma glucose.
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, 18 years or older at the time of signing informed consent * Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated dose and SU half of maximum allowed dose according to national label or higher) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose * HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive
Exclusion criteria
* Female who is pregnant, breast-feeding or intends to become pregnant or of childbearing potential not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period * Any disorder which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol * Treatment with any glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with intercurrent illness * History of chronic or idiopathic acute pancreatitis * Screening calcitonin value greater than or equal to 50 ng/L * Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2 * Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m\^2 per modification of diet in renal disease (MDRD) formula (4 variable version) * Acute coronary or cerebrovascular event within 90 days before randomisation * Heart failure, New York Heart Association Class IV * Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator * Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer) * Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c From Baseline | Week 0, week 30 | Change in HbA1c from baseline to week 30. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight From Baseline | Week 0, week 30 | Change in body weight from baseline to week 30. |
| Change in Fasting Plasma Glucose From Baseline | Week 0, week 30 | Change in fasting plasma glucose from baseline to week 30. |
| Change in Diastolic Blood Pressure. | Week 0, week 30 | Change in diastolic blood pressure from baseline to week 30. |
| Change in Systolic Blood Pressure. | Week 0, week 30 | Change in systolic blood pressure from baseline to week 30. |
| Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | Week 0, week 30 | The Short Form (SF)-36v2™ patient reported outcomes (PRO) questionnaire was used to assess the subject's overall health related quality of life (HRQoL. PRO questionnaire (SF-36v2™) measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 U.S. general population. The (SF-36v2™) values displayed are the estimated mean change from baseline to week 30. |
| Change in Patient Reported Outcome Questionnaires. (PROs), Diabetes Treatment Satisfaction Questionnaire (DTSQs) | Week 0, week 30 | The Diabetes Treatment Satisfaction Questionnaire (DTSQs) questionnaire was to be used to assess a subject's treatment satisfaction. This questionnaire contained 8 components and measured the treatment for diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment. The value presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. The values displayed are the estimated mean change from baseline to week 30. |
| Subjects Who Achieve HbA1c ≤6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) | After 30 weeks treatment | Subjects who achieve HbA1c ≤6.5% (48 mmol/mol), American Association of Clinical Endocrinologists (AACE) after 30 weeks of treatment |
Countries
Argentina, Croatia, France, Germany, India, Mexico, Netherlands, North Macedonia, Puerto Rico, Romania, Slovakia, Slovenia, South Africa, United Kingdom, United States
Participant flow
Recruitment details
The trial was conducted at196 sites in 14 countries. Argentina: 3 sites; Croatia: 3 sites; France: 5 sites; Germany: 11 sites; India: 12 sites; Macedonia: 3 sites; Mexico: 3 sites; Netherlands: 3 sites; Romania: 5 sites; Slovakia: 5 sites; Slovenia:3 sites; South Africa: 4 sites; United Kingdom: 13 sites; United States: 123 sites.
Pre-assignment details
Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin ≥1500 mg or maximum tolerated dose and SU≥ half of maximum allowed dose according to national label) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose.
Participants by arm
| Arm | Count |
|---|---|
| Semaglutide 0.5mg/Week Subjects on semaglutide followed a fixed dose-escalation. The maintenance dose of 0.5 mg was to be reached after 4 doses (4 weeks) of 0.25 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day. | 362 |
| Semaglutide 1.0 mg/Week Subjects randomised to semaglutide followed a fixed dose-escalation regimen. The maintenance dose of 1.0 mg was to be reached after 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4 weeks) of 0.5 mg semaglutide. Doses could not be changed during the trial after the maintenance dose had been reached. One test pen was to be supplied per subject at the screening visit in order to ensure the subject's willingness and ability to self-inject. The test pen contained semaglutide placebo, solution for injection, 1.5 mL prefilled PDS290 pen-injector and was to be administered once. The PDS290 pen-injector for semaglutide is a prefilled pen integrated with a 1.5 mL cartridge containing semaglutide 1.34 mg/mL and is designed to be used with NovoFine®, NovoFine® Plus and NovoTwist® disposable needles. Once weekly (same day of the week) administered by s.c. injection in thigh, abdomen or upper arm, at any time of the day. | 360 |
| Insulin Glargine Subjects on insulin glargine were to start on 10 IU s.c. injected OD. The insulin dose adjustment had to aim to reach a pre-breakfast FPG of 4.0 to \<5.5 mmol/L (71- \<100 mg/dL). Once daily solution for injection in a 3 mL pre-filled SoloStar® pen to be administered in the thigh, abdomen or upper arm, at any time of the day | 360 |
| Total | 1,082 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 2 | 0 | 2 |
| Overall Study | Lost to Follow-up | 2 | 1 | 1 |
| Overall Study | No reason for withdrawal | 12 | 11 | 7 |
| Overall Study | Withdrawal by Subject | 11 | 7 | 8 |
Baseline characteristics
| Characteristic | Semaglutide 1.0 mg/Week | Insulin Glargine | Semaglutide 0.5mg/Week | Total |
|---|---|---|---|---|
| Age, Continuous | 56.7 years STANDARD_DEVIATION 10.4 | 56.2 years STANDARD_DEVIATION 10.6 | 56.5 years STANDARD_DEVIATION 10.3 | 56.5 years STANDARD_DEVIATION 10.4 |
| Age, Customized 18-64 years | 281 Participants | 281 Participants | 278 Participants | 840 Participants |
| Age, Customized 65-74 years | 61 Participants | 67 Participants | 72 Participants | 200 Participants |
| Age, Customized 75-84 years | 18 Participants | 12 Participants | 12 Participants | 42 Participants |
| Age, Customized >=85 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Body weight | 94.00 kg STANDARD_DEVIATION 22.48 | 92.61 kg STANDARD_DEVIATION 21.52 | 93.73 kg STANDARD_DEVIATION 21.39 | 93.45 kg STANDARD_DEVIATION 21.79 |
| Diastolic Blood pressure | 80.32 mmHg STANDARD_DEVIATION 8.32 | 79.78 mmHg STANDARD_DEVIATION 9.2 | 79.67 mmHg STANDARD_DEVIATION 8.04 | 79.72 mmHg STANDARD_DEVIATION 8.53 |
| Fasting plasma glucose | 179.2 mg/dL STANDARD_DEVIATION 53.74 | 174.2 mg/dL STANDARD_DEVIATION 49.06 | 172.4 mg/dL STANDARD_DEVIATION 50.52 | 175.3 mg/dL STANDARD_DEVIATION 51.18 |
| HbA1c | 8.25 percentage STANDARD_DEVIATION 0.94 | 8.13 percentage STANDARD_DEVIATION 0.88 | 8.13 percentage STANDARD_DEVIATION 0.85 | 8.17 percentage STANDARD_DEVIATION 0.89 |
| Sex: Female, Male Female | 178 Participants | 165 Participants | 165 Participants | 508 Participants |
| Sex: Female, Male Male | 182 Participants | 195 Participants | 197 Participants | 574 Participants |
| Systolic Blood Pressure | 132.21 mmHg STANDARD_DEVIATION 16.05 | 132.38 mmHg STANDARD_DEVIATION 15.77 | 131.57 mmHg STANDARD_DEVIATION 14.06 | 132.06 mmHg STANDARD_DEVIATION 15.31 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 172 / 362 | 192 / 360 | 107 / 360 |
| serious Total, serious adverse events | 22 / 362 | 17 / 360 | 18 / 360 |
Outcome results
Primary
Change in HbA1c From Baseline
Change in HbA1c from baseline to week 30.
Time frame: Week 0, week 30
Population: The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomized semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5mg/Week | Change in HbA1c From Baseline | -1.21 percentage | Standard Error 0.05 |
| Semaglutide 1.0 mg/Week | Change in HbA1c From Baseline | -1.64 percentage | Standard Error 0.05 |
| Insulin Glargine | Change in HbA1c From Baseline | -0.83 percentage | Standard Error 0.05 |
Comparison: The post baseline responses were analysed using a mixed model for repeated measurements with treatment , country and stratum as fixed factors and baseline value as covariate, all nested within visit.p-value: <0.000195% CI: [-0.96, -0.67]Mixed Models Analysis
Comparison: The post baseline responses were analysed using a mixed model for repeated meausrements with treatment, country and stratum value as covariate, all nested within visit.p-value: <0.000195% CI: [-0.52, -0.24]Mixed Models Analysis
Secondary
Change in Body Weight From Baseline
Change in body weight from baseline to week 30.
Time frame: Week 0, week 30
Population: The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5mg/Week | Change in Body Weight From Baseline | -3.47 Kg | Standard Error 0.24 |
| Semaglutide 1.0 mg/Week | Change in Body Weight From Baseline | -5.17 Kg | Standard Error 0.24 |
| Insulin Glargine | Change in Body Weight From Baseline | 1.15 Kg | Standard Error 0.23 |
Secondary
Change in Diastolic Blood Pressure.
Change in diastolic blood pressure from baseline to week 30.
Time frame: Week 0, week 30
Population: The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5mg/Week | Change in Diastolic Blood Pressure. | -1.38 mmHg | Standard Error 0.43 |
| Semaglutide 1.0 mg/Week | Change in Diastolic Blood Pressure. | -0.98 mmHg | Standard Error 0.44 |
| Insulin Glargine | Change in Diastolic Blood Pressure. | -1.44 mmHg | Standard Error 0.41 |
Secondary
Change in Fasting Plasma Glucose From Baseline
Change in fasting plasma glucose from baseline to week 30.
Time frame: Week 0, week 30
Population: The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5mg/Week | Change in Fasting Plasma Glucose From Baseline | -36.74 mg/dL | Standard Error 2.14 |
| Semaglutide 1.0 mg/Week | Change in Fasting Plasma Glucose From Baseline | -49.21 mg/dL | Standard Error 2.15 |
| Insulin Glargine | Change in Fasting Plasma Glucose From Baseline | -38.18 mg/dL | Standard Error 2.03 |
Secondary
Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™
The Short Form (SF)-36v2™ patient reported outcomes (PRO) questionnaire was used to assess the subject's overall health related quality of life (HRQoL. PRO questionnaire (SF-36v2™) measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 U.S. general population. The (SF-36v2™) values displayed are the estimated mean change from baseline to week 30.
Time frame: Week 0, week 30
Population: The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Semaglutide 0.5mg/Week | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | Bodily pain | 0.95 T-scores | Standard Error 0.51 |
| Semaglutide 0.5mg/Week | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | General Health | 1.95 T-scores | Standard Error 0.38 |
| Semaglutide 0.5mg/Week | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | Mental Component summary, MCS | 1.23 T-scores | Standard Error 0.47 |
| Semaglutide 0.5mg/Week | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | Mental Health | 1.69 T-scores | Standard Error 0.46 |
| Semaglutide 0.5mg/Week | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | Physical Component summary, PCS | 1.18 T-scores | Standard Error 0.36 |
| Semaglutide 0.5mg/Week | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | Physical Functioning | 1.64 T-scores | Standard Error 0.43 |
| Semaglutide 0.5mg/Week | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | Role-emotional | 0.88 T-scores | Standard Error 0.54 |
| Semaglutide 0.5mg/Week | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | Role-physical | 0.90 T-scores | Standard Error 0.46 |
| Semaglutide 0.5mg/Week | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | Social functioning | 1.13 T-scores | Standard Error 0.48 |
| Semaglutide 0.5mg/Week | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | Vitality | 1.71 T-scores | Standard Error 0.46 |
| Semaglutide 1.0 mg/Week | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | Vitality | 2.09 T-scores | Standard Error 0.46 |
| Semaglutide 1.0 mg/Week | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | Bodily pain | 1.76 T-scores | Standard Error 0.51 |
| Semaglutide 1.0 mg/Week | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | Physical Functioning | 1.49 T-scores | Standard Error 0.43 |
| Semaglutide 1.0 mg/Week | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | Physical Component summary, PCS | 2.09 T-scores | Standard Error 0.36 |
| Semaglutide 1.0 mg/Week | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | General Health | 2.78 T-scores | Standard Error 0.38 |
| Semaglutide 1.0 mg/Week | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | Social functioning | 1.04 T-scores | Standard Error 0.48 |
| Semaglutide 1.0 mg/Week | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | Role-physical | 1.97 T-scores | Standard Error 0.46 |
| Semaglutide 1.0 mg/Week | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | Mental Component summary, MCS | 1.33 T-scores | Standard Error 0.47 |
| Semaglutide 1.0 mg/Week | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | Role-emotional | 1.73 T-scores | Standard Error 0.54 |
| Semaglutide 1.0 mg/Week | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | Mental Health | 1.17 T-scores | Standard Error 0.47 |
| Insulin Glargine | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | Role-physical | 0.78 T-scores | Standard Error 0.43 |
| Insulin Glargine | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | Mental Health | 0.54 T-scores | Standard Error 0.44 |
| Insulin Glargine | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | Vitality | 0.95 T-scores | Standard Error 0.44 |
| Insulin Glargine | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | Physical Component summary, PCS | 1.18 T-scores | Standard Error 0.34 |
| Insulin Glargine | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | Physical Functioning | 0.69 T-scores | Standard Error 0.41 |
| Insulin Glargine | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | Role-emotional | 0.06 T-scores | Standard Error 0.51 |
| Insulin Glargine | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | Bodily pain | 0.90 T-scores | Standard Error 0.48 |
| Insulin Glargine | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | Social functioning | 0.36 T-scores | Standard Error 0.45 |
| Insulin Glargine | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | General Health | 1.63 T-scores | Standard Error 0.36 |
| Insulin Glargine | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | Mental Component summary, MCS | 0.25 T-scores | Standard Error 0.44 |
Secondary
Change in Patient Reported Outcome Questionnaires. (PROs), Diabetes Treatment Satisfaction Questionnaire (DTSQs)
The Diabetes Treatment Satisfaction Questionnaire (DTSQs) questionnaire was to be used to assess a subject's treatment satisfaction. This questionnaire contained 8 components and measured the treatment for diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment. The value presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. The values displayed are the estimated mean change from baseline to week 30.
Time frame: Week 0, week 30
Population: The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5mg/Week | Change in Patient Reported Outcome Questionnaires. (PROs), Diabetes Treatment Satisfaction Questionnaire (DTSQs) | 4.86 Score on a scale | Standard Error 0.28 |
| Semaglutide 1.0 mg/Week | Change in Patient Reported Outcome Questionnaires. (PROs), Diabetes Treatment Satisfaction Questionnaire (DTSQs) | 5.37 Score on a scale | Standard Error 0.29 |
| Insulin Glargine | Change in Patient Reported Outcome Questionnaires. (PROs), Diabetes Treatment Satisfaction Questionnaire (DTSQs) | 3.99 Score on a scale | Standard Error 0.27 |
Secondary
Change in Systolic Blood Pressure.
Change in systolic blood pressure from baseline to week 30.
Time frame: Week 0, week 30
Population: The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5mg/Week | Change in Systolic Blood Pressure. | -4.65 mmHg | Standard Error 0.72 |
| Semaglutide 1.0 mg/Week | Change in Systolic Blood Pressure. | -5.17 mmHg | Standard Error 0.73 |
| Insulin Glargine | Change in Systolic Blood Pressure. | -1.68 mmHg | Standard Error 0.68 |
Secondary
Subjects Who Achieve HbA1c ≤6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE)
Subjects who achieve HbA1c ≤6.5% (48 mmol/mol), American Association of Clinical Endocrinologists (AACE) after 30 weeks of treatment
Time frame: After 30 weeks treatment
Population: The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 0.5mg/Week | Subjects Who Achieve HbA1c ≤6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) | Yes | 135 Count of participants |
| Semaglutide 0.5mg/Week | Subjects Who Achieve HbA1c ≤6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) | No | 227 Count of participants |
| Semaglutide 1.0 mg/Week | Subjects Who Achieve HbA1c ≤6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) | Yes | 195 Count of participants |
| Semaglutide 1.0 mg/Week | Subjects Who Achieve HbA1c ≤6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) | No | 165 Count of participants |
| Insulin Glargine | Subjects Who Achieve HbA1c ≤6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) | Yes | 63 Count of participants |
| Insulin Glargine | Subjects Who Achieve HbA1c ≤6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) | No | 297 Count of participants |