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Clinical Trial Details

Trial ID: L7196
Source ID: NCT05444153
Associated Drug: Semaglutide
Title: Research Study to Compare Semaglutide Tablets With Empagliflozin Tablets Taken Once Daily in People With Type 2 Diabetes and Obesity
Acronym: PIONEER START
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Semaglutide|DRUG: Empagliflozin
Outcome Measures: Primary: Participants acheiving glycated haemoglobin (HbA1c) less than (<) 7 percentage (%) (Yes/No), Measured as count of participants., At week 104|Participants acheiving body weight reduction greater than or equal to (>=) 5% (Yes/No), Measured as count of participants., At week 104 | Secondary: Change in HbA1c, Measured as percentage (%)-point., From randomisation (week 0) to week 104|Change in fasting plasma glucose (FPG), Measured in millimoles per liter (mmol/l)., From randomisation (week 0) to week 104|Change in self-measured plasma glucose (SPMG) 7-point mean profile, Measured in millimoles per liter(mmol/l)., From randomisation (week 0) to week 104|Change in self-measured plasma glucose (SPMG) mean post prandial increments, Measured in millimoles per liter(mmol/l)., From randomisation (week 0) to week 104|Time to additional anti-diabetic medication, Measured in days., From randomisation (week 0) to week 104|Change in body weight, Measured in kilograms (kg)., From randomisation (week 0) to week 104|Relative change in body weight, Measured as percentage (%)., From randomisation (week 0) to week 104|Change in waist circumference, Measured in centimeters (cm)., From randomisation (week 0) to week 104|Participants achieving glycated haemoglobin (HbA1c) less than or equal to (<=) 6.5% (Yes/No), Measured as count of participants., From randomisation (week 0) to week 104|Participants achieving glycated haemoglobin (HbA1c) reduction greater than or equal to (>=) 0.7%-point (Yes/No), Measured as count of participants., From randomisation (week 0) to week 104|Participants achieving body weight reduction greater than or equal to (>=) 5 percentage (%), Measured as count of participants., From randomisation (week 0) to week 104|Change in systolic blood pressure, Measured in millimiters of mercury (mmHg)., From randomisation (week 0) to week 104|Change in total cholesterol, Measured as ratio to baseline., From randomisation (week 0) to week 104|Change in high density lipoprotein (HDL), Measured as ratio to baseline., From randomisation (week 0) to week 104|Change in low density lipoprotein (LDL), Measured as ratio to baseline., From randomisation (week 0) to week 104|Change in very low density lipoprotein (VLDL), Measured as ratio to baseline., From randomisation (week 0) to week 104|Change in Triglycerides, Measured as ratio to baseline., From randomisation (week 0) to week 104|Change in free fatty acids, Measured as ratio to baseline., From randomisation (week 0) to week 104|Number of treatment emergent adverse events, Measured as count of events., From randomisation (week 0) to week 109|Change in Control of Eating Questionnaire (CoEQ) score - Craving Control domain, Measured as score on a scale. Scales range from 0 (minimum) to 10 (maximum)., From randomisation (week 0) to week 104|Change in Control of Eating Questionnaire (CoEQ) score - Craving for Savory domaina, Measured as score on a scale. Scales range from 0 (minimum) to 10(maximum)., From randomisation (week 0) to week 104
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-10-06
Completion Date: 2025-08-29
Results First Posted:
Last Update Posted: 2022-11-14
Locations:
URL: https://clinicaltrials.gov/show/NCT05444153