To Evaluate the Effect of Liraglutide on Ambulatory Blood Pressure-A Pilot Study
Condition: Diabetes Mellitus, Non-Insulin-Dependent; Hypertensive Disease
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Liraglutide or Placebo
Intervention description: All subjects will be advised a low sodium diet. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval.
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: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus; Hypertension; ambulatory blood pressure monitoring; Endothelial Dysfunction; Pulse pressure; Renin-angiotensin system; heart rate variability

Summary:

      The investigators are conducting this research to study the effect of Liraglutide on blood
      pressure. Several studies have shown increased cardiovascular complications and deaths in
      diabetics with hypertension. The importance of blood pressure control in diabetes has been
      shown in many clinical trials. No drug already approved for treating Type 2 Diabetes Mellitus
      is known to reduce blood pressure along with improving diabetes. However, prior research
      studies with liraglutide have suggested that treatment with liraglutide improves blood
      pressure. This effect is seen very quickly and even prior to any weight loss. The mechanism
      behind this effect is yet to be determined.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes, as an adjunct to diet and exercise to improve glycemic control (as
             per approved label.

          -  HbA1c>7% and ≤10.5% at randomization.

          -  Men and women of 18-75 years of age.

          -  Women of childbearing potential must agree to use contraception or must not otherwise
             be at risk of becoming pregnant. A urine pregnancy test will be done at the time of
             screening and then every 4 weeks for the duration of 8 weeks. If positive, this will
             be confirmed with a serum pregnancy test which if positive, appropriate action will be
             taken as outlined in the detailed protocol.

          -  Blood pressure≥ 130/80 mm Hg and ≤160/100mmHg on stable treatment (no change in anti
             hypertensive treatment for 3 months prior to screening) or no treatment. No change in
             treatment for BP over 8 weeks of the study will be allowed.

          -  Patient understands the study procedures, alternative treatments are available, and
             the risks involved with the study, and voluntarily agree to participate by providing
             written informed consent.

        Exclusion Criteria:

          -  1. Type 1 diabetes and/or history of ketoacidosis determined by medical history.

             2. History of severe diabetic or autonomic neuropathy, gastroparesis or limb
             ulceration or amputation.

             3. Therapy with DPP-4 inhibitor, or GLP -1 analog or receptor agonist in the past 6
             months.

             4. Pregnant, breast-feeding or the intention of becoming pregnant or not using
             adequate contraceptive measures.

             5. Patients on corticosteroids within 3 months or recurrent continuous corticosteroid
             treatment (>2 weeks).

             6. Use of weight loss drugs within 3 months of screening or weight loss of ≥10 % in
             the last 6 months.

             7. Surgery in the past 30 days prior to screening and/or any serious or chronic
             illness within 6 months or anticipated surgery during the trial period.

             8. Serum creatinine >1.4mg/dL (women)/>1.5mg/dL (men). 9. Serum Triglyceride Level
             >500 mg/dL. 10. History of pancreatitis. 11. History of drug or alcohol abuse. 12.
             Poor mental function or any reason to expect patient difficulty in complying with
             study requirements.

             13. Contraindications to Liraglutide: Personal or family history of medullary thyroid
             cancer or MEN-2 syndrome 14. Known or suspected allergy to Liraglutide. 15. Diagnosed
             Secondary hypertension.