Dapagliflozin As Additional Treatment To Liraglutide And Insulin In Patients With Type 1 Diabetes

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University at Buffalo
• Treatments: Dapagliflozin; Insulin; Insulin, Globin Zinc; Liraglutide

Criteria

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.