To Evaluate the Effect of Liraglutide on Ambulatory Blood Pressure-A Pilot Study

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.

Blood pressure will be monitored using the 24 hour Ambulatory Blood Pressure monitor: a
device that monitors your blood pressure while you continue normal activity. We have chosen
this method to monitor blood pressure because most of the prior studies have proven it to be
superior over a single blood pressure recording and its ability to better predict clinical
outcomes.

It is well known that both diabetes and hypertension cause endothelial dysfunction.
Endothelium is the inner lining of the blood vessels. When it is functioning, it is supposed
to regulate blood clotting, help with the body's immune response, controls the volume of
fluid and other substances that pass through the blood vessels. Hence, normal endothelial
function protects the blood vessels from atherosclerosis (hardening) and builds up of
plaque. When it is not functioning well (as in diabetes, hypertension, cigarette smokers
etc.) it does not perform one or more of these functions. Hence, in this study, we will also
measure the endothelial function using a machine: ENDO PAT.

This is a non-invasive diagnostic test which is done in the doctor's office. Usually takes
about 15 minutes. It is not painful. It generates an EndoScore which indicates the current
state of the endothelial health.

This is a PILOT study (a small-scale study designed to determine if a larger, full-scale
study is doable) to prove this effect which if proven will be extended to a larger,
multicenter trial.

Of note: Liraglutide has already been approved for treating Type 2 Diabetes Mellitus.

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.