Phase 3 · Liraglutide

NCT02518945 trial results

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.

Participants
26
Status
completed
Completed
2016-04
Sponsor
University at Buffalo

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.

Primary outcome

What NCT02518945 measured first

Absolute Change After 12 Weeks From Baseline in Mean HbA1c With Addition of Dapagliflozin Compared to Placebo.% HbA1c · 12 weeks · mean
Placebon=9Active Drugsn=17
0(0.2)-0.66(0.1)
Secondary outcomes

What else it measured

Change in Time Spent at Normal Glucose Concentrations Between 70-160mg/dlpercentage of time · 12 weeks · mean
Placebon=9Active Drugsn=17
-1.4(1.0)10(4)
Change in 24-hour Urine Glucose Excretion.gram/day · 12 weeks. · mean
Placebon=9Active Drugsn=17
2.1(1.1)66.9(4.7)
Change in Total Daily Insulin RequirementsUnits/Kg · 12 weeks · mean
Placebon=9Active Drugsn=17
-0.1(2.4)-3.5(1.9)
Change in Body WeightKg · 12 weeks · mean
Placebon=9Active Drugsn=17
0.7(1.5)-1.9(0.5)
Change in Systolic Blood Pressure Before and After TreatmentmmHg · 12 weeks · mean
Placebon=9Active Drugsn=17
-2(3)-12(4)
Change in Blood Ketone BodiesmM · 12 weeks · mean
Placebon=9Active Drugsn=17
-0.03(0.06)0.20(0.09)
The trial

How NCT02518945 was run

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.

  • Placebo: 12 weeks of treatment with Insulin, Liraglutide and "Dapagliflozin Placebo"
  • Active drugs: 12 weeks of treatment with Insulin, Liraglutide and "Active Dapagliflozin Drug"
Who could join the trial

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.

Published papers

Papers from NCT02518945

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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