At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 120 enrolled
Drug / intervention
Dapagliflozin +2 moredrug
Likely dose
Dapagliflozin 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect of Dapagliflozin, Metformin and Physical Activity on Glucose Variability, Body Composition and Cardiovascular Risk in Pre-diabetes
In Brief
A Phase 2 clinical trial evaluating Dapagliflozin, Metformin, and 1 other intervention for Prediabetic State and Obesity. Completed, enrolled 120 participants across 1 site.
Detailed Summary
The overall objective is to compare the short-term (3 months) effectiveness of three glucose-lowering interventions (dapagliflozin, metformin and physical activity) on glucose variability, body composition, and cardiometabolic risk factors in overweight or obese individuals with pre-diabetes (HbA1c 5.7-6.4% / 39-47 mmol/mol).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrediabetic State, Obesity
CountriesDenmark
CollaboratorsThe Novo Nordic Foundation, Rigshospitalet, Denmark, AstraZeneca, Bayer
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartFeb 2016
First PostedMar 2016
Primary CompletionSep 2018
Study CompletionJan 2019
TodayJul 2026
First PostedMar 1, 2016
Enrollment StartFeb 24, 2016
Primary CompletionSep 20, 2018
Study CompletionJan 13, 2019
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 10.3 years ago
Interventions
Dapagliflozindrug
10 mg per day as monotherapy for 13 weeks
Metformindrug
2 x 850 mg per day as monotherapy for 13 weeks
Exercisebehavioral
Interval training, 5 times per week, 30 min per session