Status:
TERMINATED
Development of A Novel Anti-Hyperglycemic Agent
Lead Sponsor:
VA Office of Research and Development
Conditions:
Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this clinical trial is to test the effectiveness and safety of a new anti-diabetes drug (Cyclo-Z) for the prevention and treatment of Type 2 diabetes. This study will determine dose-dep...
Detailed Description
We have demonstrated that a cyclic dipeptide Cyclo (his-pro) plus zinc (Cyclo-Z) treatment improved clinical conditions of diabetes in various animal models and a phase 1 clinical trial. The main obje...
Eligibility Criteria
Inclusion
- History of type 2 diabetes mellitus who are na ve to hypoglycemic treatment, inadequately controlled by diet and exercise alone or oral medications.
- 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 Diabetes Mellitus (DM).
- Fasting blood glucose levels reasonably stable for at least 2 months or during the two-week lead-in-period.
- Ethnicity: All ethnic groups.
- Gender: Both men and women.
- Female with reproductive potential must not be pregnant or lactating, and using reliable contraception methods.
- Age \>18 years old.
Exclusion
- Taking insulin.
- History of diabetic ketoacidosis or hyper osmolar non-ketotic coma.
- 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
- 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.
- 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.
- 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).
- Renal disease: Serum creatinine \> 1.5 mg/dL for men, and \> 1.4 mg/dL for women.
- Lung disease:
- Chronic obstructive airway disease or asthma requiring daily therapy.
- Use of home oxygen.
- Anemia: Hematocrit of \< 36.0% in men or \< 33% in women.
- 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)
- Medications
- Psychoactive agents such as Monoamine oxidase inhibitors and Antidepressive agents (lithium, prozac, zoloft, serzone, paxil, effexor)
- Systemic use of glucocorticoids steroids within previous 6 weeks.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2013
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00878605
Start Date
April 1 2010
End Date
September 30 2013
Last Update
June 14 2018
Active Locations (1)
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1
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073