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

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT02518945

Run by

University at Buffalo

People needed

26

Starts

2015-08-01

Expected to finish

2016-04-01

Last updated by the study team

2024-01-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• ECMC Ambulatory Center, 3rd Floor — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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