Development of A Novel Anti-Hyperglycemic Agent

NCT00878605 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: CLIN-010-08F
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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-dependent efficacy and safety of this new drug for the treatment of human diabetes. The Food and Drug Administration has granted approval for the use of this investigational product to be used in a study \[FDA approval (Investigational New Drug) IND #: 61,897\]. This new drug is thought to work by increasing the amount of zinc in your body, which in turn should improve your sugar metabolism. If this study successfully proves that Cyclo-Z is effective for the treatment of diabetes and is without significant side effects, a large, multi-center study of diabetic patients will then be performed.

Conditions

Diabetes

Keywords

Diabetes; Cyclo-Z

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1C

  % change HgbA1c from baseline to 12 weeks.

  Baseline and Week 12

Study Arms (4)

Cyclo-Z (minimally effective)

EXPERIMENTAL

3mg CHP plus 20mg zinc containing gel capsule;

Drug: Cyclo-Z

Cyclo-Z (maximally effective)

EXPERIMENTAL

9mg CHP plus 20mg zinc containing gel capsule;

Drug: Cyclo-Z

Cyclo-Z (not additionally effective)

EXPERIMENTAL

15mg CHP plus 20mg zinc containing gel capsule

Drug: Cyclo-Z

Placebo (for CHP)

PLACEBO COMPARATOR

Placebo capsules containing no zinc or CHP

Drug: Placebo

Interventions

Cyclo-Z DRUG

Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose

Also known as: CHP

Cyclo-Z (maximally effective); Cyclo-Z (minimally effective); Cyclo-Z (not additionally effective)

Placebo DRUG

Placebo control

Also known as: Sugar pill manufactured to mimic Cyclo-Z

Placebo (for CHP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Z 008; Sugars

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Limitations and Caveats

This subject was terminated early and data was not analyzed due to inability to recruit and therefore small numbers of subjects to analyze leading to uninterpretable data.

Results Point of Contact

• Title: Dr. Zhaoping Li, Section Chief
• Organization: VA Greater Los Angeles Healthcare System

zhaoping.li@va.gov

310-268-3528

Study Officials

• Zhaoping Li, MD

  VA Greater Los Angeles Healthcare System, West Los Angeles, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2009
• First Posted: April 9, 2009
• Study Start: April 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: September 30, 2013
• Last Updated: June 14, 2018
• Results First Posted: February 11, 2015

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)