Development of A Novel Anti-Hyperglycemic Agent

• Register: ClinicalTrials.gov
• Last refreshed on: 18 February 2013
• Main ID: NCT00878605
• Date of registration: 07/04/2009
• Primary sponsor: Department of Veterans Affairs
• Public title: Development of A Novel Anti-Hyperglycemic Agent
• Scientific title: Development of A Novel Anti-Hyperglycemic Agent
• Date of first enrolment: October 2009
• Target sample size: 120
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00878605
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Zhaoping Li, MD
• Affiliation: VA Greater Los Angeles Healthcare System, West LA

Key inclusion & exclusion criteria

Inclusion Criteria:

1. History of type 2 diabetes mellitus who are na ve to hypoglycemic treatment,
inadequately controlled by diet and exercise alone or oral medications.

2. Hemoglobin A1c level of 6.5 % to 8.0 % inclusive. Subjects not taking hypoglycemic
drugs with HgbA1c of 6.0% to 6.5% must have a diagnosis of DM.

3. Fasting blood glucose levels reasonably stable for at least 2 months or during the
two-week lead-in-period.

4. Ethnicity: All ethnic groups.

5. Gender: Both men and women.

6. Female with reproductive potential must not be pregnant or lactating, and using
reliable contraception methods.

7. Age >18 years old.

Exclusion Criteria:

1. Taking insulin.

2. History of diabetic ketoacidosis or hyper osmolar non-ketotic coma.

3. Diabetes Mellitus related end-organ damage:

- Evidence of diabetic autonomic and peripheral neuropathy

- Diabetic proliferative retinopathy, based on eye exam by ophthalmologist

- Diabetes nephropathy defined by > 500 mg/24 hour urinary albumin excretion

4. Any disease likely to limit life span and/or increase risks of interventions:

- Screening carotid B-mode ultrasound indicating clinically significant stenos in
the common carotid arteries requiring intervention by angioplasty or resection.

- Cancer treatment in the past 5 years, with the exception of cancers that have
been cured, and carry a good prognosis.

- Infectious disease: HIV positivity, active tuberculosis, or pneumonia.

5. Cardiovascular disease:

- Hospitalization for treatment of heart disease in the past 12 months.

- New York Heart Association Functional Class > 2.

- Left Bundle branch block on EKG.

- Third degree atrioventricular block on EKG.

- Uncontrolled hypertension with average systolic blood pressure of > 160 mmHg on
two screening visits and diastolic blood pressure > 95 mmHg on two screening
visit.

- Pulse rate > 95 beats per minute on both screening visits.

- Stroke or transient ischemic attack in the past 12 months.

6. Gastrointestinal disease:

- Chronic hepatitis or cirrhosis.

- Episode of alcoholic hepatitis or alcoholic pancreatitis.

- Inflammatory bowel disease requiring treatment in the past 12 months.

- Recent or significant abdominal surgery (e.g. gastrectomy, gastric bypass).

7. Renal disease: Serum creatinine > 1.5 mg/dL for men, and > 1.4 mg/dL for women.

8. Lung disease:

- Chronic obstructive airway disease or asthma requiring daily therapy.

- Use of home oxygen.

9. Anemia: Hematocrit of < 36.0% in men or < 33% in women.

10. Conditions or behaviors likely to affect the conduct of the study

- Unable or unwilling to give informed consent.

- Unable to communicate with the clinic staff.

- Unwilling to accept treatment assignment by randomization.

- Weight loss of > 10% in the past 6 months.

- Unable to walk without any assisted device.

- Major psychiatric disorder which would impede conduct of the research.

- Excessive alcohol intake (more than 2 drinks/day)

11. Medications

- Psychoactive agents such as Monoamine oxidase inhibitors and Antidepressive
agents (lithium, prozac, zoloft, serzone, paxil, efflexor)

- Systemic use of glucocorticoids steroids within previous 6 weeks.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes

Intervention(s)

Drug: Cyclo-Z

Drug: Placebo

Primary Outcome(s)

Decrease of Hgb A1c [Time Frame: 12 weeks]

Secondary ID(s)

CLIN-010-08F

Source(s) of Monetary Support

Please refer to primary and secondary sponsors