Study to Explore the Effect of Dapagliflozin and Stress in Adolescent and Adult Subjects With Type 1 Diabetes (T1D)

Summary

Participation Requirements

Description

The purpose of the Dapastress trial is, to evaluate if some metabolic parameters can be identified as an early marker or contributor in development of ketonic metabolic imbalance. As the hormonal "background" is completely different in pubertal adolescents compared to adults (especially contra-insul...

The purpose of the Dapastress trial is, to evaluate if some metabolic parameters can be identified as an early marker or contributor in development of ketonic metabolic imbalance. As the hormonal "background" is completely different in pubertal adolescents compared to adults (especially contra-insulin hormones as growth hormone, glucagon). Approximately 20 subjects 18-45 years will be screened in order to randomize 16 patients, where stress and Dapagliflozin (or corresponding placebo) will be administered independently. The trial will consist of 14 visits: a screening visit (Visit 1), 4 overnight visits complexes (Visit 2 to Visit 13), including phone visits and a follow-up visit (Visit 14). Furthermore, an information visit will take place prior to the screening visit in order to obtain patient's informed consent. Screening will take place 2-21 days prior to Visit 2. The follow-up visit will take place 5-21 days after the end of Visit 13. The overnight visits will be separated by a wash-out period (5-30 days between the end of each visit complex and start of next complex) during which the subjects will resume their normal insulin treatment. Each phone visit will take place 3-5 days after the end of overnight Visits. The planned total duration of the trial is 58-100 days per subject (rescheduled visits excluded). Each subject will be randomised to a unique treatment sequence (1:1:1:1). Seq 1: A D B C Seq 2: B A C D Seq 3: C B D A Seq 4: D C A B (e.g. A Dapa-Stress, B Dapa-Placebo Stress , C Placebo- Stress, D Placebo-Placebo Stress) After randomization patients will receive Dapagliflozin/placebo for 5 single daily Dosis. During the overnight visits the metabolic control will be achieved by a variable i.v. Infusion of human Insulin by an Infusion pump. The procedure will be used in order to aim and maintain blood glucose levels between 70 and 180 mg/dl. The fluid Infusion and Insulin dosing scheme will depend on Body weight and blood glucose levels. At approximately 03:00 hours in the morning the blood glucose should be within target range. Then insulin infusion will be suspended. In the morning the last dose of actual study medication (Dapagliflozin/ Placebo) and the single dose of stress (ACTH or placebo) will be administered. During now started stress phase blood samples for determination of metabolic Panels,blood gas analysis, Glucose and ketone will be taken hourly and vital signs tested. 12 hours after administration of stress (ACTH or placebo) the patients will resume their CSII and will be discharged when being well on investigator's judgement.

Tracking Information