Klinische Studies Radar

Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority Analysis]

HbA1c is the glycated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over the last 2-3 months. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + GLP-1 RA Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputation approach.

Baseline, Week 52

Change From Baseline in HbA1c [Superiority]

HbA1c is the glycated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + GLP-1 RA Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputation approach.

Baseline, Week 52

Change From Baseline in Fasting Glucose

Change from baseline in fasting blood glucose measured by self-monitoring blood glucose (SMBG). LS mean was determined using ANCOVA model with Variable = Baseline + Country + GLP-1 RA Use at Baseline + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares).

Baseline, Week 52

Basal Insulin Dose at Week 52

The insulin dose was recorded daily or weekly in an electronic diary. The average weekly basal insulin dose at Week 52 was reported. LS mean was determined using MMRM model with Baseline + Hemoglobin A1c Stratum at Baseline + Country + GLP-1 RA use at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Week 52

Rate Per Year of Hypoglycemia Events

Rate of Composite Level 2 and 3 Hypoglycemia Events were reported. Hypoglycemia with glucose \<54 mg/dL (Level 2) or Severe Hypoglycemia confirmed by the investigator to be an event that required assistance for treatment (Level 3) was reported. A severe hypoglycemic event is characterized by altered mental or physical status requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions for the treatment of hypoglycemia. Group mean was reported and determined by Negative binomial model using Number of episodes = Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.

Baseline up to Week 52

Percentage of Participants With Hypoglycemia Events (Incidence)

Incidence of hypoglycemic episodes is defined as 100 multiplied by the number of participants experiencing a hypoglycemic episode divided by the number of participants exposed to the study drug. Incidence of Composite Level 2 and 3 Hypoglycemia Events was reported. Hypoglycemic episodes are defined as an event that is associated with reported signs and symptoms of hypoglycemia with glucose \<54 mg/dL (Level 2) or severe hypoglycemia confirmed by the investigator to be an event that required assistance for treatment (Level 3). A severe hypoglycemic event is characterized by altered mental or physical status requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions for the treatment of hypoglycemia.

Week 52

Rate Per Year of Nocturnal Hypoglycemia Events

The event rate of participant-reported clinically significant glucose \<54 mg/dL (3.0 mmol/L) or severe nocturnal hypoglycemia that occurs at night and presumably during sleep between midnight and 6:00 AM), measured during treatment period up to week 52. Group mean is reported here. Group mean is determined by Negative Binomial Model using Number of episodes = .Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.

Baseline up to Week 52

Percentage of Participants With Nocturnal Hypoglycemia Events (Incidence)

Incidence of nocturnal hypoglycemic episodes is defined as 100 multiplied by the number of participants experiencing a hypoglycemic episode divided by the number of participants exposed to the study drug. Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. The event rate of participant-reported clinically significant glucose \<54 mg/dL (3.0 mmol/L) or severe nocturnal hypoglycemia that occurs at night and presumably during sleep between midnight and 6:00 AM), measured during treatment period up to week 52..

Week 52

Change From Baseline in Body Weight

Change from baseline in body weight was reported. LS mean was determined using ANCOVA model with Variable = Baseline + Country + GLP-1 RA Use at Baseline + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares).

Baseline, Week 52

Change From Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D) Total Score

The TRIM-D is a self-administered instrument, which assesses the impact of diabetes treatment on participants' functioning and well-being across available diabetes treatments. The TRIM-D consists of 28 items, each assessed on a 5-point scale. The TRIM-D questionnaire consists of 5 sub-domains. Treatment Burden (6 items) Daily Life (5 items) Diabetes Management (5 items), Compliance (4 items), and Psychological Health (8 items), where each question is scored on a 1-5-point scale with a higher score indicating a better health state (less negative impact). Mean TRIM-D individual sub-domain scores and total scores are later transformed to a 0-100 scale for analysis. LS mean change in scores from baseline to 52 weeks for total score are presented here. LS mean was determined using MMRM model with BASELINE + Hemoglobin A1c Stratum at Baseline + Country + GLP-1 RA. Use at Randomization + Treatment + Time + Treatment\*Time(Type III sum of squares) as variables.

Baseline, Week 52

Change From Baseline in Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQ-c)

The DTSQ-c is a validated, patient-reported questionnaire designed to assess perceived changes in satisfaction with diabetes treatment over time. It is especially useful in clinical trials comparing a new treatment to a previous one. The DTSQ-c includes 8 items, each scored on a 7-point Likert scale ranging from -3 (Much less satisfied) to +3 (Much more satisfied). A score of 0 indicates no change in perception. This outcome reports three domains: (1) Perceived frequency of hypoglycaemia - lower scores reflect fewer perceived episodes; (2) Perceived frequency of hyperglycaemia - lower scores reflect fewer perceived episodes; (3) Treatment satisfaction -Aggregated score from the remaining 6 items assessing satisfaction with treatment, convenience, flexibility, understanding, and willingness to continue. A higher scores indicating greater improvement in satisfaction. Total score range: -18 to +18.

Baseline, Week 52

Percentage of Participants Reporting Treatment Experience Using the Simplicity of Diabetes Treatment Questionnaire (SIM-Q) Single Medication Status Version

The SIM-Q is a brief 10-item measure developed to assess the simplicity and complexity of treatment for T2D. This version of the instrument assesses the simplicity and complexity of a single medication. Only the last 2 questions/items of the SIM-Q were completed by the study participants: 1. "How simple or complex is your medication treatment for diabetes?" 2. "Overall, how simple or complex is it to manage your diabetes, including medication, checking your blood glucose levels, diet, and any other aspects of diabetes treatment?" Participants were asked to provide responses to the study intervention at Week 52. Each item is scored on a 5-point scale ranging from "Very complex" to "Very simple." Higher scores indicate a more favorable (simpler) treatment experience.

Week 52

Change From Baseline in Diabetes Injection Device Experience Questionnaire (DID-EQ) in Device Characteristics

DID-EQ is a validated, self-administered, 10-item PRO instrument designed to assess participants' perceptions of diabetes injection delivery systems.This outcome measure reports only the Device Characteristics Subscale, which includes Items 1 through 7. These items evaluate specific features of injection devices such as: * Ease of preparation * Comfort during injection * Portability * Discreetness * Confidence in dose delivery * Ease of learning to use * Satisfaction with device features Each item is rated on a 4-point Likert scale: Strongly Disagree, Disagree, Agree, Strongly Agree. Responses are transformed to a 0-100 scale, where 0 represents most negative perception and 100 represents the most positive perception.Higher scores indicate more favorable perceptions of the injection device. LS Mean determined using ANCOVA model with Country + GLP-1 RA Use at Randomization + HbA1c Stratum at Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Baseline, Week 52

Percentage of Participants in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) (3-Global Items)

The DID-EQ is a validated, self-administered, 10-item PRO instrument designed to assess participants' perceptions of diabetes injection delivery systems. This outcome measure specifically reports the summary of DID-EQ scores for the 3 global items: * Item 8: Overall satisfaction with the injection device * Item 9: Ease of use of the injection device * Item 10: Convenience of the injection device Each item is rated on a 4-point Likert scale: * Strongly Disagree * Disagree * Agree * Strongly Agree Responses are transformed to a 0-100 scale, where: * 0 = Most negative perception * 100 = Most positive perception Higher scores indicate more favorable perceptions of the injection device's global characteristics.

Week 52