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Clinical Trial Details

Trial ID: L5554
Source ID: NCT04665570
Associated Drug: Bay81-9783 (Acarbose/Metformin)
Title: A Study to Learn More About How Acarbose and Metformin Work When Taken Together and How Safe They Are in Indian Patients Who Were Recently Diagnosed With Type 2 Diabetes (T2D)
Acronym: START-AM
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: BAY81-9783 (Acarbose/Metformin)
Outcome Measures: Primary: Mean change in HbA1c, HbA1c: Glycated Hemoglobin, From baseline to end of week 24 | Secondary: Change in HbA1c, From baseline to end of week 12|Change in fasting blood glucose, From baseline to end of week 6, week 12, week 24|Change in postprandial glucose level, From baseline to end of week 6, week 12, week 24|Occurrence of Hypoglycemic events, From baseline up to 24 weeks|Severity of Hypoglycemic events, From baseline up to 24 weeks|Occurrence of Gastrointestinal intolerance, From baseline up to 24 weeks|Occurrence of other AEs relating to tolerability, From baseline up to 24 weeks|Change in patient tolerability to therapy, From baseline up to 24 weeks|Mean change in body weight, From baseline to end of week 12, week 24|Mean change in lipid profile, From baseline up to 24 weeks|Descriptive analysis of starting dose and final dosing, From baseline up to 24 weeks|Descriptive analysis of time taken for full dose titration, From baseline up to 24 weeks|Descriptive analysis of PPG recorded at each visit, From baseline up to 24 weeks|Descriptive analysis of FBG recorded at each visit, From baseline up to 24 weeks|Descriptive analysis of HbA1c recorded at each visit, From baseline up to 24 weeks|Descriptive analysis of body weight recorded at each visit, From baseline up to 24 weeks|Descriptive analysis of actual duration of treatment with acarbose/metformin FDC before addition of other anti-diabetes drugs, From baseline up to 24 weeks|Descriptive analysis of time of addition of the other anti-diabetes drug, From baseline up to 24 weeks|Descriptive analysis of reason of addition of the other anti-diabetes drug, From baseline up to 24 weeks|Descriptive analysis of reason for discontinuation of acarbose/metformin FDC treatment, From baseline up to 24 weeks|Descriptive analysis of adverse events (AEs), AEs assessed and recorded by the physician on the AE report form attached to the case report form, From baseline up to 24 weeks
Sponsor/Collaborators: Sponsor: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 2000
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2020-12-21
Completion Date: 2024-09-05
Results First Posted:
Last Update Posted: 2024-09-23
Locations: Many locations, Multiple Locations, India
URL: https://clinicaltrials.gov/show/NCT04665570