Adding Liraglutide to High Dose Insulin: Breaking the Cycle
Condition: Type 2 Diabetes Mellitus; Obesity
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Liraglutide; Saline
Intervention description: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months; Placebo injection of 1.8mg saline once daily for 6-months
Intervention MeSH terms: Liraglutide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Insulin; Glucagon-like peptide; Liraglutide; Beta-Cell; pancreatic steatosis; hepatic steatosis

Summary:

      The purpose of this study is to evaluate whether the addition of liraglutide 1.8 mg/day to a
      high-dose insulin regimen (>1.8 units/kg/day) in patients with uncontrolled (HbA1c >7.5%)
      type 2 diabetes mellitus will improve blood sugar control.

      It also evaluates the effect of liraglutide on liver and pancreatic fat content, explores the
      mechanism of blood sugar improvement by assessing weight and pancreatic hormone release, and
      assesses blood pressure, lipid profile, and liver function. Finally it will look at patient
      quality of life and safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus

          -  Insulin dose of >1.8 units/kg/day (represents total daily insulin dose, regardless of
             formulation, regimen, number of daily shots)

          -  HbA1c ≥ 7.5% and ≤ 11%

          -  Age ≥ 18

          -  Stable comorbidities on stable treatment regimens

          -  Stable dose of all oral hypoglycemics for ≥ 3 months prior to enrollment

          -  Ability to provide informed consent before any trial-related activities

        Exclusion Criteria:

          -  Type 1 diabetes mellitus

          -  Any contraindication to the MRI procedure (metallic implants, severe claustrophobia,
             pregnancy, unable to lie still on a hard table for the duration of the procedure,
             weight above 400 lb - limit of the MRI table, magnet's inner circumference smaller
             than the largest body circumference)

          -  History of any pancreatic disease as it might interfere with the pancreatic TG
             measurement (i.e. pancreatitis, tumors, cysts, type 1 diabetes, any pancreatic
             surgery)

          -  End Stage Renal Disease on dialysis due to increased risk of hypoglycemia, and
             possible interference with accurate measurement of HbA1c

          -  Incretin therapy (any GLP-1 agonist or DPP-IV inhibitor)

          -  Unstable or decompensated comorbidities

          -  Personal or family history of medullary thyroid carcinoma or MEN-2 syndrome

          -  Severe gastroparesis

          -  Pregnancy, breast feeding, intention to become pregnant, or not using adequate
             contraceptive measures

          -  Organ transplant recipient or waiting list candidate

          -  Steroid use (current or potential use during the trial)

          -  Known/suspected allergy to trial medication, excipients, or related products

          -  Contraindications to study medications, worded specifically as stated in the product's
             prescribing information

          -  Non-English speaking volunteers since no interpreters are available and the safety of
             the volunteers could be jeopardized if adequate and reliable communication is not
             possible.