Development of A Novel Anti-Hyperglycemic Agent

This study has been terminated.
(Unable to reach accrual target.)
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00878605
First received: April 7, 2009
Last updated: January 26, 2015
Last verified: January 2015
Results First Received: December 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Diabetes
Interventions: Drug: Cyclo-Z
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study recruitment commenced on June 1, 2009 under version 1.0 of the protocol, upon approval of the study by the IRB. The first participant was enrolled April 2010, and the last January 2013. Participants received either Cyclo-Z gel 3mg + 20mg zinc; Cyclo-Z gel 9 mg + 20mg zinc; Cyclo-Z gel 15mg + 20mg zinc or Placebo once daily for 12 weeks.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm 1

Placebo control

Placebo: Placebo control

Participants received placebo tablet orally daily for 12 weeks.

Arm 2

Active medication

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

Participants received Cyclo-Z gel 3mg + 20 mg zinc orally per day for 12 weeks.

Arm 3

Active medication efficacy dose

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

Participants received Cyclo-Z gel 9mg + 20 mg zinc orally per day for 12 weeks.

Arm 4

Active medication high dose

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

Participants received Cyclo-Z gel 15mg + 20 mg zinc orally per day for 12 weeks.


Participant Flow:   Overall Study
    Arm 1     Arm 2     Arm 3     Arm 4  
STARTED     10     10     9     9  
COMPLETED     7     7     8     6  
NOT COMPLETED     3     3     1     3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo

Placebo control

Placebo: Placebo control

Cyclo-Z Gel 3mg + 20 mg Zinc

Active medication

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

Cyclo-Z Gel 9mg + 20 mg Zinc

Active medication efficacy dose

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

Cyclo-Z Gel 15mg + 20 mg Zinc

Active medication high dose

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

Total Total of all reporting groups

Baseline Measures
    Placebo     Cyclo-Z Gel 3mg + 20 mg Zinc     Cyclo-Z Gel 9mg + 20 mg Zinc     Cyclo-Z Gel 15mg + 20 mg Zinc     Total  
Number of Participants  
[units: participants]
  10     10     9     9     38  
Age  
[units: years]
Mean (Full Range)
  58.7   (18 to 80)     61.9   (18 to 80)     63.4   (18 to 80)     59.5   (18 to 80)     60.8   (18 to 80)  
Gender  
[units: participants]
         
Female     1     1     0     3     5  
Male     9     9     9     6     33  
Ethnicity (NIH/OMB)  
[units: participants]
         
Hispanic or Latino     0     0     0     0     0  
Not Hispanic or Latino     10     10     9     9     38  
Unknown or Not Reported     0     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
         
American Indian or Alaska Native     0     0     0     0     0  
Asian     0     1     0     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0  
Black or African American     8     5     8     8     29  
White     2     4     1     1     8  
More than one race     0     0     0     0     0  
Unknown or Not Reported     0     0     0     0     0  
Baseline Demographics  
[units: participants]
  10     10     9     9     38  



  Outcome Measures

1.  Primary:   Hemoglobin A1C   [ Time Frame: Baseline and Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Zhaoping Li, Section Chief
Organization: VA Greater Los Angeles Healthcare System
phone: 310-268-3528
e-mail: zhaoping.li@va.gov


No publications provided


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00878605     History of Changes
Other Study ID Numbers: CLIN-010-08F
Study First Received: April 7, 2009
Results First Received: December 17, 2014
Last Updated: January 26, 2015
Health Authority: United States: Federal Government
United States: Food and Drug Administration