Triple Therapy for Type 1 Diabetes with Insulin, Semaglutide and Dapagliflozin.

Phase 1

• Conditions: Type 1 diabetes; MedDRA version: 21.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2018-004120-11-GB
• Lead Sponsor: HS Greater Glasgow and Clyde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-16
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

1) Type 1 Diabetes for at least 1 year on stable multiple daily (four or more) injections (MDI) of insulin or continuous subcutaneous insulin infusion (CSII) for the previous three months.
2) C-peptide < 0.23 nM
3) Minimum dose of insulin: 0.5 U/kg for MDI and 0.4 U/kg for CSII
4) Regularly measuring blood glucose four or more times daily by fingerprick, (or by flash or continuous glucose monitoring).
5) HbA1c >7.5%
6) Well versed in Carbohydrate (CHO) counting*
7) Age 18-70 years.
8) BMI =25 kg/m2.

*In the opinion of the site Principal Investigator

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17

Exclusion Criteria

1) Type 1 diabetes for < 12 months, type 2 diabetes, chronic pancreatitis, MODY
2) Previous use of any agent other than insulin for glycaemic control in the last three months.
3) History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g. emergency room visit and/or hospitalisation) within three months prior to the screening visit.
4) Following ketogenic diet, low (<50g/day) carbohydrate diet or intermittent fasting.
5) Hypoglycaemia unawareness* or frequent episodes of severe hypoglycaemia as defined by more than one episode requiring medical assistance, emergency care (paramedics or emergency room care), or glucagon therapy administered by a third-party individual within three months prior to the screening visit
6) Symptoms of poorly controlled diabetes
7) Participation in a weight loss program with ongoing weight loss, or in an intensive exercise program
8) History of bariatric or other weight-loss surgery within 12 months prior to the screening visit
9) History of Addison’s disease or chronic adrenal insufficiency
10) History of diabetes insipidus
11) Hepatic disease or cirrhosis
12) Aspartate Aminotransferase (AST) > 3 X Upper limit of normal (ULN) and/or Alanine aminotransferase (ALT) > 3 X ULN
13) Serum Total Bilirubin > 2 X ULN unless exclusively caused by Gilbert’s Syndrome
14) Haemoglobin < 110 g/L (11.0 g/dL) for men; haemoglobin < 100 g/L (10.0 g/dL) for women
15) Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous three months or history of congestive heart failure
16) End stage renal disease on haemodialysis and/or eGFR < 60 ml/min/1.73m2
17) HIV or Hepatitis B/C positive status
18) Any other life-threatening, non-cardiac disease
19) History of pancreatitis or cystic fibrosis
20) Women who are pregnant, planning pregnancy or breast-feeding and women of childbearing potential (WOCBP) who are not established on a method of adequate contraception considered highly effective (see Appendix 2) and willing to continue it for the duration of the study and for at least two months after last dose of IMP.
21) Inability to give informed consent
22) History of gastroparesis
23) History of medullary thyroid carcinoma or MEN 2 syndrome
24) History of hypersensitivity reaction to GLP-1 agonists or SGLT2 inhibitors or known hypersensitivity to any of the excipients
25) Known gallstones (history of cholecystectomy is not an exclusion criterion)
26) History of alcohol problem or drug abuse
27) Hypertriglyceridemia (>500 mg/dl)
28) Recurrent genital mycotic infection (more than one episode in last six months)
29) Hypovolaemia
30) Any malignancy except treated in situ malignancy and basal cell carcinoma of the ski
31) Unexplained haematuria (dipstick positive on two occasions one week apart) and/or active bladder cancer
32) Proliferative retinopathy (on basis of photographic retinal screening which must have been performed within the last 12 months
33) Use of an investigational agent or therapeutic regimen within 90 days of study
34) Participation in any other concurrent interventional clinical trial
35) Unlikely to be able to comply with study requirements*
* In the opinion of the site Principal Investigator

Study & Design

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