Cinnamon Bark, Water-Soluble Cinnamon Extract, and Metformin for Treatment of Type 2 DM.

We are studying whether or not cinnamon bark or water-soluble cinnamon could be an effective
nutraceutical for the initial treatment of diabetes when compared to standard therapy of
metformin 1000 mg (extended-release). This study will enroll 309 subjects type 2 diabetics
(using American Diabetes Association criteria) on no hypoglycemic medications. Subjects will
be randomized into one of three groups, group 1 will receive oral extended-release Metformin
1000mg, group 2 will receive Cinnamon Bark 1000mg, group 3 will receive cinnulin PF 500mg.
Subjects will be instructed to take their study pills once a day for 90 days.After 90 days
of treatment, each subject will again have hemoglobin A1C, lipid panel, height, weight,
blood pressure and waist circumference measured. Analysis described above using
intention-to-treat principles for any missing data will be used (we will use the
carry-forward method to impute missing data). Subjects will bring in any remaining
medication to determine adherence rates to the study protocol.

THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE
IN ORDER TO PARTICIPATE IN THIS STUDY.

Inclusion:

- Patients 18 years or older.

- Diagnosed with type 2 diabetes mellitus within the past 30 days or who have been
diagnosed and have not begun treatment.

Exclusion:

- Subjects who are <18 yrs of age.

- Pregnant or breastfeeding.

- Allergic to cinnamon.

- Allergic to metformin.

- Patients taking metformin are excluded from participating, unless they agree to wash
out for two weeks prior to entering the study.

- Patients taking Cinnamon as a dietary supplement are excluded from participating,
unless they agree to wash out for two weeks prior to entering the study.

- Patients taking any of the following:

- Daily oral steroids

- Warfarin

- Hypoglycemic medication

- Weight loss medication

- Digoxin, lithium, phenytoin, & theophylline (due to narrow therapeutic indices)

- Serum creatinine >1.5 (this is standard of care that would be measured by PCM upon
diagnosis of type 2 diabetes mellitus)

- Initial hemoglobin A1C >9.5(this is standard of care that would be measured by PCM
upon diagnosis of type 2 diabetes mellitus).

- Clinical or laboratory evidence of liver disease.

- Clinical or laboratory evidence of Alcoholism.

- New York Heart Association (NYHA) Class III and IV congestive heart failure.

- Class III: Cardiac disease resulting in marked limitation of physical activity -
less than ordinary activity causes fatigue, palpitation, dyspnea, or angina.
Comfortable at rest.

- Class IV: Cardiac disease resulting in inability to carry on any physical
activity without discomfort or symptoms. Symptoms may be present at rest. If any
physical activity is undertaken, discomfort or symptoms are increased.

- Patients who are known to have or develop during the study any of the following upon
review of their medical record:

- Celiac disease

- Insulinoma

- Cushings Disease

- Hyperthyroidism

- Acromegaly

- Phechromocytoma

- Addison's Disease

- Galactosemia

- Glycogen storage disease

- Hereditary fructose intolerance