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

Triple Therapy for Type 1 Diabetes with Insulin, Semaglutide and Dapagliflozin - TTT1 study

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004120-11-GB

Enrollment

114

Registered

2020-03-16

Start date

2020-05-05

Completion date

Unknown

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes MedDRA version: 21.1 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Ozempic Product Name: Ozempic Product Code: Not applicable Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: Semaglutide CAS Number: 910463-68-2 Current

Eligibility

Sex/Gender

All

Inclusion criteria

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 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

Exclusion criteria: 1) Type 1 diabetes for 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 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess whether the addition of a drug designed to increase the amount of sugar removed from the body (dapagliflozin) and semaglutide to insulin (triple therapy) improves blood glucose control in patients with type 1 diabetes compared with semaglutide and insulin (dual therapy) and insulin only (standard) treatment. ;Secondary Objective: To assess whether 1: Semaglutide in addition to insulin treatment over 26 and 52 weeks will significantly improve HbA1c levels compared with insulin therapy alone. 2: Combined dapagliflozin and semaglutide treatment in addition to insulin will significantly improve glucose control and the percent of time spent in normal zone range (80-160mg/dl) with lower insulin requirements compared with semaglutide and insulin (dual therapy) or insulin only (standard) treatment treatment alone. 3: combined dapagliflozin and semaglutide treatment will improve postprandial glucose excursions and suppress postprandial glucagon compared with semaglutide and insulin or insulin therapy alone. 4: Combined dapagliflozin and semaglutide in addition to insulin therapy will reduce blood pressure compared with semaglutide and insulin (dual therapy) or insulin only (standard) treatment. 5: Combined dapagliflozin and semaglutide in addition to insulin therapy (triple therapy) will result in weight loss co;Primary end point(s): The Primary Outcome measure of this study is to assess in people with type 1 diabetes whether triple therapy (dapagliflozin, semaglutide and insulin) reduces HbA1c in comparison with dual therapy (placebo, semaglutide, and insulin).	—

Measure

Time frame

Main Objective: To assess whether the addition of a drug designed to increase the amount of sugar removed from the body (dapagliflozin) and semaglutide to insulin (triple therapy) improves blood glucose control in patients with type 1 diabetes compared with semaglutide and insulin (dual therapy) and insulin only (standard) treatment. ;Secondary Objective: To assess whether 1: Semaglutide in addition to insulin treatment over 26 and 52 weeks will significantly improve HbA1c levels compared with insulin therapy alone. 2: Combined dapagliflozin and semaglutide treatment in addition to insulin will significantly improve glucose control and the percent of time spent in normal zone range (80-160mg/dl) with lower insulin requirements compared with semaglutide and insulin (dual therapy) or insulin only (standard) treatment treatment alone. 3: combined dapagliflozin and semaglutide treatment will improve postprandial glucose excursions and suppress postprandial glucagon compared with semaglutide and insulin or insulin therapy alone. 4: Combined dapagliflozin and semaglutide in addition to insulin therapy will reduce blood pressure compared with semaglutide and insulin (dual therapy) or insulin only (standard) treatment. 5: Combined dapagliflozin and semaglutide in addition to insulin therapy (triple therapy) will result in weight loss co;Primary end point(s): The Primary Outcome measure of this study is to assess in people with type 1 diabetes whether triple therapy (dapagliflozin, semaglutide and insulin) reduces HbA1c in comparison with dual therapy (placebo, semaglutide, and insulin).

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Secondary

Measure	Time frame
Secondary end point(s): Efficacy: Change in HbA1c Mean fasting blood glucose Mean blood glucose* Percentage time in range (3.9 - 10.0 mmol/)* Standard deviation of blood glucose* Percentage time in hyperglycaemia Level 1 (10.1 - 13.9 mmol/L/)* Percentage time in hyperglycaemia Level 2 (>13.9 mmol/L) * Percent time in hypoglycaemia Level 1 (3.0 - 3.8 mmol/)* (* by masked DEXCOM G6 CGM) Insulin requirement Bodyweight Systolic and diastolic BP Number of antihypertensive medications Diabetes Specific Quality of Life Scale (DSQOLS) Problem Areas In Diabetes (PAID) questionnaire Safety: Rate of hypoglycemic events Level 2 (<3.0 mmol/L/ <54mg/dl) Rate of hypoglycemic events Level 3 (severe event with altered mental and/or physical status requiring assistance) Rate of diabetic ketoacidosis defined as elevated serum or urine ketones (greater than the upper limit of the normal range), and serum bicarbonate < 15 mmol/L or blood pH < 7.3	—

Measure

Time frame

Secondary end point(s): Efficacy: Change in HbA1c Mean fasting blood glucose Mean blood glucose* Percentage time in range (3.9 - 10.0 mmol/)* Standard deviation of blood glucose* Percentage time in hyperglycaemia Level 1 (10.1 - 13.9 mmol/L/)* Percentage time in hyperglycaemia Level 2 (>13.9 mmol/L) * Percent time in hypoglycaemia Level 1 (3.0 - 3.8 mmol/)* (* by masked DEXCOM G6 CGM) Insulin requirement Bodyweight Systolic and diastolic BP Number of antihypertensive medications Diabetes Specific Quality of Life Scale (DSQOLS) Problem Areas In Diabetes (PAID) questionnaire Safety: Rate of hypoglycemic events Level 2 (<3.0 mmol/L/ <54mg/dl) Rate of hypoglycemic events Level 3 (severe event with altered mental and/or physical status requiring assistance) Rate of diabetic ketoacidosis defined as elevated serum or urine ketones (greater than the upper limit of the normal range), and serum bicarbonate < 15 mmol/L or blood pH < 7.3

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Countries

United Kingdom, United States

Contacts

Public ContactDr Maureen Travers

NHS Greater Glasgow and Clyde

Maureen.Travers@ggc.scot.nhs.uk01413144012

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026