Logo 1 Logo 2

Clinical Trial Details

Trial ID: L4756
Source ID: NCT02965443
Associated Drug: Dapagliflozin 10 Mg + Saxagliptin 5 Mg
Title: Dapagliflozin + Saxagliptin in a Basal-bolus Insulin Treatment
Acronym: DapaSaxaBBIT
Status: TERMINATED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Dapagliflozin 10 mg + Saxagliptin 5 mg|DRUG: Placebo 1 10 mg + Placebo 2 5 mg
Outcome Measures: Primary: Percentage of subjects achieving a HbA1c ≤ 7.5% and having a reversal from a BBIT to a BOT regimen, Percentage of subjects achieving a HbA1c ≤ 7.5% and having a reversal from a BBIT to a BOT regimen with treatment of dapagliflozin/saxagliptin or placebo, 24 weeks | Secondary: changes in HbA1c between groups, treatment of dapagliflozin/saxagliptin or placebo, 24 weeks|changes in hypoglycaemic events between groups, treatment of dapagliflozin/saxagliptin or placebo, 24 weeks|changes in fasting blood glucose between groups, treatment of dapagliflozin/saxagliptin or placebo, 24 weeks|changes in daily insulin dose between groups, treatment of dapagliflozin/saxagliptin or placebo, 24 weeks|changes in bodyweight between groups, treatment of dapagliflozin/saxagliptin or placebo, 24 weeks|changes in body fat content between groups, treatment of dapagliflozin/saxagliptin or placebo, 24 weeks|changes in body fat distribution between groups, treatment of dapagliflozin/saxagliptin or placebo, 24 weeks|changes in liver fat content between groups, treatment of dapagliflozin/saxagliptin or placebo, 24 weeks|changes in intra-nasal insulin-induced brain fMR (functional magnetic resonance) imaging results between groups, treatment of dapagliflozin/saxagliptin or placebo, 24 weeks|changes in blood pressure between groups, treatment of dapagliflozin/saxagliptin or placebo, 24 weeks|changes in the blood lipid profile between groups, treatment of dapagliflozin/saxagliptin or placebo, 24 weeks|changes in microalbuminuria between groups, treatment of dapagliflozin/saxagliptin or placebo, 24 weeks|changes in well being and disease perception between groups, treatment of dapagliflozin/saxagliptin or placebo, 24 weeks|changes in fear of hypoglycemia between groups, treatment of dapagliflozin/saxagliptin or placebo, 24 weeks | Other: changes in fetuin-A levels between groups, treatment of dapagliflozin/saxagliptin or placebo, 24 weeks|changes in adiponectin levels between groups, treatment of dapagliflozin/saxagliptin or placebo, 24 weeks|changes in (Interleucin 1?ßß) IL-1ß levels between groups, treatment of dapagliflozin/saxagliptin or placebo, 24 weeks|changes in Il-6 levels between groups, treatment of dapagliflozin/saxagliptinn or placebo, 24 weeks|differences in adverse events between groups, treatment of dapagliflozin/saxagliptin or placebo, 24 weeks|differences in severe adverse events between groups, treatment of dapagliflozin/saxagliptin or placebo, 24 weeks|differences in heart rate between groups, treatment of dapagliflozin/saxagliptin or placebo, 24 weeks|differences in ECG parameters between groups, treatment of dapagliflozin/saxagliptin or placebo, 24 weeks|changes in clinical chemistry/haematology parameters between groups, treatment of dapagliflozin/saxagliptin or placebo, 24 weeks
Sponsor/Collaborators: Sponsor: University Hospital Tuebingen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 4
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2018-02-02
Completion Date: 2020-02-03
Results First Posted:
Last Update Posted: 2020-02-11
Locations: University Hospital Tübingen, Tübingen, 72076, Germany
URL: https://clinicaltrials.gov/show/NCT02965443