What NCT02518945 measured first
| Placebon=9 | Active Drugsn=17 |
|---|---|
| 0(0.2) | -0.66(0.1) |
Dapagliflozin As Additional Treatment To Liraglutide And Insulin In Patients With Type 1 Diabetes. A Randomized Clinical Trial
Absolute Change After 12 Weeks From Baseline in Mean HbA1c With Addition of Dapagliflozin Compared to Placebo. (% HbA1c), 12 weeks. Placebo: 0; Active Drugs: -0.66.
As posted on ClinicalTrials.gov (NCT02518945), updated at source Jan 24, 2024. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
| Placebon=9 | Active Drugsn=17 |
|---|---|
| 0(0.2) | -0.66(0.1) |
| Placebon=9 | Active Drugsn=17 |
|---|---|
| -1.4(1.0) | 10(4) |
| Placebon=9 | Active Drugsn=17 |
|---|---|
| 2.1(1.1) | 66.9(4.7) |
| Placebon=9 | Active Drugsn=17 |
|---|---|
| -0.1(2.4) | -3.5(1.9) |
| Placebon=9 | Active Drugsn=17 |
|---|---|
| 0.7(1.5) | -1.9(0.5) |
| Placebon=9 | Active Drugsn=17 |
|---|---|
| -2(3) | -12(4) |
| Placebon=9 | Active Drugsn=17 |
|---|---|
| -0.03(0.06) | 0.20(0.09) |
This is a single center, prospective, randomized, double blinded placebo controlled study conducted I patients with type 1 diabetes.The aim of this study is to examine the additive effects of GLP-1 agonist and SGLT2 inhibitor in patients with type 1 diabetes in terms of possible improved glycemic control, reduced glycemic variability, reduced insulin dosages, additional effects of weight loss and blood pressure reduction.
Inclusion Criteria: * Patients with type 1 diabetes mellitus: Fasting c-peptide \< 0.1nmol/l on insulin therapy for more than 12 months with or without history of diabetic ketoacidosis and treatment with liraglutide at maximal tolerated doses for at least 6 months prior to start of the study. * Willing to use a continuous glucose monitoring device (CGM) and regularly measuring their blood sugars four times daily * HbA1c of less than or equal to 11%. * Well versed with carbohydrate counting * Age 18-75 years Exclusion Criteria: * Type 1 diabetes for less than 12 months. * Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks * Hepatic disease (transaminase \> 3 times normal) or cirrhosis * ESRD on hemodialysis; and or e-GFR less than 30 ml/min/1.73m2 * HIV or Hepatitis C positive status * Participation in any other concurrent clinical trial * Any other life-threatening, non-cardiac disease * Use of an investigational agent or therapeutic regimen within 30 days of study * History of pancreatitis * Pregnancy * Inability to give informed consent * History of gastroparesis * History of medullary thyroid carcinoma or MEN 2 syndrome * Family history of MEN 2, Family history of medullary thyroid cancer, or familial medullary thyroid cancer * Women of childbearing potential who are not using adequate contraception * Women who are pregnant * History of serious hypersensitivity reaction to these agents.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.