DiabetesPhase 2NCT00878605
Development of A Novel Anti-Hyperglycemic Agent
A Phase 2 study testing Cyclo-Z in people with Diabetes, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Cyclo-Z
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2010to 30 Sep 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 39Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073
About this study
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.
Read the 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 objective of this study is to demonstrate that this product is safe and effective for the treatment of human diabetes.
Research Plan This is a randomized, double blinded, placebo-controlled, and parallel study. In this study, we will recruit 120 hypoglycemic drug na ve type 2 diabetic patients and randomize them into 4 groups of 30 subjects each to compare the effects of a Cyclo-Z capsule containing Cyclo-His Pro (CHP) 0 (placebo), 3 mg (minimally effective), 9 mg (optimally effective), or 15 mg (no-additional effect) plus 20 mg zinc on diabetic symptoms in a 12-week trial period. The primary outcome of this study is improvement of hemoglobin A1c; secondary outcomes are fasting blood glucose, 2 hours postprandial glucose and glucose tolerance test. Safety will be assessed by the presence of severe adverse events (SAEs), adverse events (AEs), any changes of vital signs, physical exams, blood hematology, chemistry, liver, renal, thyroid function tests, urine analysis and zinc, copper levels.
Clinical Significance The proposed study has a direct impact on veteran's healthcare service. The applicant has obtained two types of US and international patent approvals for preventing and treating human diabetes and obesity with Cyclo-Z. One patent application for Alzheimer's disease treatment has just been approved. These patent rights are now assigned to the DVA. Based on our background studies and observation we anticipate the proposed Phase 2a clinical trials will prove that Cyclo-Z treatment is safe and effective for the treatment of human diabetes and we will be able to present a new class of anti-diabetes drug to improve healthcare of both the VA diabetic patients and the general public.
- Conditions
- Diabetes
- Being tested
- Cyclo-Z, Placebo
- Keywords
- Diabetes, Cyclo-Z
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclo-ZDrug
Also called CHP
Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose
PlaceboDrug
Also called Sugar pill manufactured to mimic Cyclo-Z
Placebo control
| Study group | Role | What they receive |
|---|---|---|
| Cyclo-Z (minimally effective) | Experimental | 3mg CHP plus 20mg zinc containing gel capsule; Receives: Drug: Cyclo-Z |
| Cyclo-Z (maximally effective) | Experimental | 9mg CHP plus 20mg zinc containing gel capsule; Receives: Drug: Cyclo-Z |
| Cyclo-Z (not additionally effective) | Experimental | 15mg CHP plus 20mg zinc containing gel capsule Receives: Drug: Cyclo-Z |
| Placebo (for CHP) | Placebo comparator | Placebo capsules containing no zinc or CHP Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1C
% change HgbA1c from baseline to 12 weeks.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study start1 Apr 2010
- Primary completion1 Jun 2013
- Study completion30 Sep 2013
Why it stopped: Unable to reach accrual target.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Zhaoping Li, MD, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878605
- Sponsor's protocol ID
- CLIN-010-08F
- Status last verified
- May 2018
- First submitted
- 7 Apr 2009
- Last updated
- 14 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of A Novel Anti-Hyperglycemic Agent
- ClinicalTrials.gov ID
- NCT00878605
- Acronym / sponsor ID
- CLIN-010-08F
- Conditions
- Diabetes
- Keywords
- Diabetes, Cyclo-Z
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to reach accrual target.
- Enrolment
- 38 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2010 (actual)
- Primary completion
- 1 Jun 2013 (actual)
- Study completion
- 30 Sep 2013 (actual)
- First posted
- 9 Apr 2009 (estimated)
- Results
- Posted 11 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 objective of this study is to demonstrate that this product is safe and effective for the treatment of human diabetes.
Research Plan This is a randomized, double blinded, placebo-controlled, and parallel study. In this study, we will recruit 120 hypoglycemic drug na ve type 2 diabetic patients and randomize them into 4 groups of 30 subjects each to compare the effects of a Cyclo-Z capsule containing Cyclo-His Pro (CHP) 0 (placebo), 3 mg (minimally effective), 9 mg (optimally effective), or 15 mg (no-additional effect) plus 20 mg zinc on diabetic symptoms in a 12-week trial period. The primary outcome of this study is improvement of hemoglobin A1c; secondary outcomes are fasting blood glucose, 2 hours postprandial glucose and glucose tolerance test. Safety will be assessed by the presence of severe adverse events (SAEs), adverse events (AEs), any changes of vital signs, physical exams, blood hematology, chemistry, liver, renal, thyroid function tests, urine analysis and zinc, copper levels.
Clinical Significance The proposed study has a direct impact on veteran's healthcare service. The applicant has obtained two types of US and international patent approvals for preventing and treating human diabetes and obesity with Cyclo-Z. One patent application for Alzheimer's disease treatment has just been approved. These patent rights are now assigned to the DVA. Based on our background studies and observation we anticipate the proposed Phase 2a clinical trials will prove that Cyclo-Z treatment is safe and effective for the treatment of human diabetes and we will be able to present a new class of anti-diabetes drug to improve healthcare of both the VA diabetic patients and the general public.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cyclo-Z (minimally effective) | Experimental | Drug: Cyclo-Z3mg CHP plus 20mg zinc containing gel capsule; |
| Cyclo-Z (maximally effective) | Experimental | Drug: Cyclo-Z9mg CHP plus 20mg zinc containing gel capsule; |
| Cyclo-Z (not additionally effective) | Experimental | Drug: Cyclo-Z15mg CHP plus 20mg zinc containing gel capsule |
| Placebo (for CHP) | Placebo comparator | Drug: PlaceboPlacebo capsules containing no zinc or CHP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (39 listed)
- Taking insulin.
- History of diabetic ketoacidosis or hyper osmolar non-ketotic coma.
- Diabetes Mellitus related end-organ damage:
- Any disease likely to limit life span and/or increase risks of interventions:
- Cardiovascular disease:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclo-ZAlso: CHPCyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose | Drug | Cyclo-Z (maximally effective), Cyclo-Z (minimally effective), Cyclo-Z (not additionally effective) |
| PlaceboAlso: Sugar pill manufactured to mimic Cyclo-ZPlacebo control | Drug | Placebo (for CHP) |
Primary outcome
Hemoglobin A1C
Time frame: Baseline and Week 12
% change HgbA1c from baseline to 12 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaoping Li, MD principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclo-Z in people with Diabetes, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1C (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2018.