A Randomized, Double-Blind, Placebo-controlled, Single-center Phase 1 Inpatient Pilot Study to Explore the Safety and Efficacy of DAPAglifozin as Add-on to day and night closed-loop control using the DreaMed Substance Administration Device Software in Adolescent and Adult Subjects with Type 1 Diabetes mellitus

Phase 1

Active, not recruiting

• Conditions: Type 1 Diabetes mellitus; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2016-002212-41-DE
• Lead Sponsor: Stiftung Hannoversche Kinderheilanstalt, Kinder - und Jugendkrankenhaus AUF DER BULT, Diabeteszentrum für Kinder - und J

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-04
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Male or female aged 12-21 years (both inclusive)
2.Type 1 diabetes mellitus (as diagnosed clinically) = 12 months
3.No DKA 12 weeks prior to the study
4.On CSII (insulin pump therapy) since at least 3 months
5.Average daily dose of Insulin between 0.6 – 2.0 U/kg
6.Body mass index 18 to 35 kg/m2 or the 10th to 99th centile for BMI according to age and gender with a minimum weight of 50kg
7.A1c range 6,5% – 11% (inclusive)

Are the trial subjects under 18? yes
Number of subjects for this age range: 15
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Anamnestic history of hypersensitivity to the study drugs (or any component of the study drug) or to drugs with similar chemical structures
3. History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (creatinine > 1.1 mg/dl in women and > 1.5 mg/dl in men), neurological, psychiatric and/or hematological disease as judged by the investigator
9. Lack of compliance or other similar reason that, according to investigator, precludes satisfactory participation in the study
10. History of T2DM, maturity onset diabetes of young (MODY), pancreatic surgery or chronic pancreatitis
11. Any use of oral hypoglycemic agents within 12 months prior to the screening visit
12. History of diabetes ketoacidosis (DKA) within 12 weeks prior to prior to the screening visit
13. History of diabetes insipidus
14. History of hospital admission for glycemic control (either hyperglycemia or hypoglycemia) within 3 months prior to prior to the screening visit
15. Frequent episodes of hypoglycemia as defined by more than one episode requiring assistance, emergency care (paramedics or emergency room care) or glucagon therapy, or more than 2 unexplained episodes of symptomatic hypoglycemia within 3 months prior to the screening visit. 16. Hypoglycemic unawareness
History of Addison’s disease or chronic adrenal insufficiency
18. Aspartate aminotransferase (AST) > 2X Upper limit of normal (ULN)
19. Alanine aminotransferase (ALT) > 2X ULN
20. Serum total bilirubin > 2X ULN
21. Estimated GFR (eGFR) by the Modification of Diet in Renal Disease (MDRD)
24. Hemoglobin = 11.0 g/dl (110 g/l) for boys / men; hemoglobin =10.0 g/dl (100 g/L) for girls / women.
25. Creatine kinase (CK) > 3X ULN
27. Abnormal Free T4 Note: abnormal TSH value at screening will be further evaluated for free T4. Subjects with abnormal free T4 values will be excluded. A one-time retest may be allowed, as determined by the Investigator, after a minimum of 6 weeks following the adjustment of thyroid hormone replacement therapy in subject who have had a prior diagnosis of a thyroid disorder and who are currently receiving thyroid replacement therapy. Such cases should be discussed with the Investigator prior to retesting. The subject must have all screening procedures and laboratory assessments performed as part of this re-test, and all of these must meet enrolment eligibility criteria. The subject’s number will, however, remain the same as initially assigned.
28. Allergies or contraindication to the contents of dapagliflozin tablets or insulin
29. Renal, Hepatic, Hemotological/Oncological Diseases/Conditions
30. History of unstable or rapidly progressing renal disease
31. Conditions of congenital renal glucosuria
32. Renal allograft
33. Significant hepatic disease, including but not limited to, chronic active hepatitis and/or severe hepatic insufficiency
34. Documented history of hepatotoxicity with any medication
35. Documented history of severe hepatobiliary disease
36. History of hemoglobinopathy, with the exception of sickle cell trait (SA) or thalassemia minor; or chronic or recurrent hemolysis
52. No clinical conditions or clinically significant abnormalities, in any laboratory value(s) collected after screening and prior to randomization which, in the Investigator’s judgment, should preclude entry into the treatment period.
53. Subjects who meet one or more of the dosing day exclusion crit

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified