Dapagliflozin As Additional Treatment To Liraglutide And Insulin In Patients With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Dapagliflozin; Insulin; Liraglutide; Dapagliflozin placebo
Intervention description: Dapagliflozin or Farxiga is a SGLT-2 inhibitor; Victoza(Liraglutide) is a GLP-1 agent.; Dapagliflozin placebo looking similar to active drug Dapagliflozin in external appearance but not containing active ingredient dapagliflozin
Intervention MeSH terms: Dapagliflozin; Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Type 1 Diabetes; Liraglutide; Dapagliflozin; Triple Therapy

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.
    

Eligibility 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.