Radar des Essais Cliniques

Change in glycated haemoglobin (HbA1c)

Measured as percentage (%)-points.

From baseline (week 0) to end of treatment (week 40)

Relative change in body weight

Measured in %.

From baseline (week 0) to end of treatment (week 40)

Number of participants who achieve greater than or equal to (>=) 10% body weight reduction

Measured as count of participants.

From baseline (week 0) to end of treatment (week 40)

Number of participants who achieve >=15% body weight reduction

Measured as count of participants.

From baseline (week 0) to end of treatment (week 40)

Number of participants who achieve HbA1c target values of less than (<) 7.0% (<53 millimoles per mole [mmol/mol])

Measured as count of participants.

At end of treatment (week 40)

Number of participants who achieve HbA1c target values of less than or equal to (<=) 6.5% (<= 48 mmol/mol)

Measured as count of participants.

At end of treatment (week 40)

Change in Fasting Plasma Glucose (FPG)

Measured in millimoles per liter (mmol/L).

From baseline (week 0) to end of treatment (week 40)

Number of participants who achieve >=5% body weight reduction

Measured as count of participants.

From baseline (week 0) to end of treatment (week 40)

Number of participants who achieve >=20% body weight reduction

Measured as count of participants.

From baseline (week 0) to end of treatment (week 40)

Change in waist circumference

Measured in centimeters (cm).

From baseline (week 0) to end of treatment (week 40)

Change in systolic blood pressure (SBP)

Measured in millimeters of mercury (mmHg).

From baseline (week 0) to end of treatment (week 40)

Change in diastolic blood pressure (DBP)

Measured in mmHg.

From baseline (week 0) to end of treatment (week 40)

Ratio to baseline in high sensitivity C-reactive protein (hsCRP)

Measured as ratio.

From baseline (week 0) to end of treatment (week 40)

Ratio to baseline in lipids: Total cholesterol

Measured as ratio.

From baseline (week 0) to end of treatment (week 40)

Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol

Measured as ratio.

From baseline (week 0) to end of treatment (week 40)

Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol

Measured as ratio.

From baseline (week 0) to end of treatment (week 40)

Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol

Measured as ratio.

From baseline (week 0) to end of treatment (week 40)

Ratio to baseline in lipids: Triglycerides

Measured as ratio.

From baseline (week 0) to end of treatment (week 40)

Ratio to baseline in lipids: Free fatty acids

Measured as ratio.

From baseline (week 0) to end of treatment (week 40)

Ratio to baseline in lipids: Non-HDL cholesterol

Measured as ratio.

From baseline (week 0) to end of treatment (week 40)

Number of participants who achieve type 2 diabetes (T2D) remission (HbA1c <6.5% and no antidiabetic medication)

Measured as count of participants.

At end of study (week 52)

Ratio to baseline in oral glucose tolerance test (OGTT) based oral glucose disposition index (DIo)

Measured as ratio.

From baseline (week 0) to end of treatment (week 40)

Change in experienced level of energy as measured by the SF-36v2 Health Survey Acute (SF-36v2) Vitality score

Measured as score points. SF-36v2 Acute measures Health-Related Quality of Life (HRQoL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The vitality score range is from 25.6 to 69.1.

From baseline (week 0) to end of treatment (week 40)

Change in SF-36v2 score: Physical Component Summary score

Measured as score points. SF-36v2 Acute measures HRQoL. The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The score range for physical component summary is 6.1 to 79.7.

From baseline (week 0) to end of treatment (week 40)

Change in SF-36v2 score: Mental Component Summary score

Measured as score points. SF-36v2 Acute measures HRQoL. The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The score range for mental component summary score is -3.8 to 78.7.

From baseline (week 0) to end of treatment (week 40)

Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score

Measured as score points. DTSQs measures treatment satisfaction and diabetes-specific quality of life. The measure consists of 8 items yielding 1 global score and 2 single item scores. Higher scores on the global score indicate greater satisfaction with treatment. Lower scores on the single-item scores indicate BG levels closer to the ideal, while higher scores indicate problems. Single-item scores (score range): Perceived frequency of hyperglycaemia (0-6), Perceived frequency of hypoglycaemia (0-6). Global score (score range): Total Treatment Satisfaction (0-36).

From baseline (week 0) to end of treatment (week 40)

Change in leptin

Measured in nanograms per milliliter (ng/mL).

From baseline (week 0) to end of treatment (week 40)

Change in soluble leptin receptor

Measured in ng/mL.

From baseline (week 0) to end of treatment (week 40)

Number of Treatment Emergent Adverse Events (TEAEs)

Measured as count of events.

From baseline (week 0) to end of treatment +7 weeks (week 47)

Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol (54 milligrams per deciliter [mg/dL]), confirmed by blood glucose (BG) meter

Measured as count of episodes.

From baseline (week 0) to end of treatment +7 weeks (week 47)

Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold

Measured as count of episodes.

From baseline (week 0) to end of treatment + 7 weeks (week 47)