Type 2 DiabetesPhase 1NCT01511900
A Multiple Ascending Dose Study of CAT-1004 in Patients With Type 2 Diabetes
A Phase 1 study testing CAT 1004 in people with Type 2 Diabetes, run by Catabasis Pharmaceuticals at 1 site in United States.
Trial summary
The primary objective of the study is to evaluate the safety of escalating multiple doses over 2 weeks of CAT 1004 compared to placebo in patients with Type 2 diabetes (T2D). Secondary objectives include evaluation of the pharmacokinetics (PK) and pharmacodynamics of escalating multiple doses of CAT-1004 in patients… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- CAT 1004
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Apr 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient must meet all of the following criteria to be in the study:
- Age between 18 to 65 years inclusive at Screening.
- Diagnosis of T2D:
- For Part I:
- Treated with any diet and exercise, with or without metformin (stable for ≥ 2 months).
- HbA1c ≥ 7.0% and ≤ 10.0% if on diet and exercise alone, or ≥6.5 % and ≤ 9.0% if on metformin.
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- For Part II:
- Stable on metformin for ≥ 2 months with HbA1c ≥ 7.0% and ≤ 10.0%.
- Satisfies one of the following:
- Females not of childbearing potential: non-pregnant and non-lactating; surgically sterile or postmenopausal for 2 years or at least 1 year with a follicle stimulating hormone assessment (FSH) greater than or equal to 40 IU/L; OR
- Males: surgically sterile, abstinent, or patient or partner is utilizing an acceptable contraceptive method during and 3 months after the last study dose.
- On a stable diet with body mass index (BMI): 25 to 40 kg/m2 inclusive at Screening with weight stable (± 4 kg) for > 6 weeks prior to Screening.
Who cannot join
- A patient will not be eligible if any of the following criteria apply:
- Use of prescription medications other than allowed medications within 30 days of planned admission to the clinic. Allowed medications include metformin, anti-hypertensives, lipid-lowering medications, thyroid replacement therapy, low-dose aspirin (81 mg/day), proton pump inhibitors and anti-depressants. Prescribed doses of these medications must have been stable for 2 months at the time of first dose.
- Clinically significant abnormalities in physical examination or vital signs at screening
- Clinically significant electrocardiogram (ECG) abnormalities as assessed by the investigator.
- Clinically significant laboratory result as assessed by the Investigator.
- The patient has a history of clinically significant medical disease including significant allergies (except for untreated, asymptomatic seasonal allergies at the time of dosing), or hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease, other than T2D, hypertension, dyslipidemia, hypothyroidism or depression.
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- History or presence of malignancy within the past 5 years.
- History of Type 1 diabetes or clinically significant cardiovascular disease (including a history of unstable angina, acute myocardial infarction, coronary artery bypass graft, percutaneous coronary intervention, or New York Heart Association Class III or IV congestive heart failure within 6 months prior to screening) or clinically significant renal disease.
- History of alcohol or substance abuse or eating disorder within 2 years, OR regular use of alcohol within 6 months (>14 units of alcohol per week; 1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol).
- Use of any investigational drug or participation in any investigational study within 30 days prior to screening or 5 half-lives of the study agent, whichever is longer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CAT-1004 in Patients With Type 2 Diabetes
The primary objective of the study is to evaluate the safety of escalating multiple doses over 2 weeks of CAT 1004 compared to placebo in patients with Type 2 diabetes (T2D).
Secondary objectives include evaluation of the pharmacokinetics (PK) and pharmacodynamics of escalating multiple doses of CAT-1004 in patients with T2D.
- Conditions
- Type 2 Diabetes
- Being tested
- CAT 1004, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAT 1004Drug
Multiple dose oral administration once daily for 14 days of CAT 1004 at dose level 1-9 subjects will be treated with CAT-1004
PlaceboDrug
Multiple dose oral administration of placebo daily for 14 days-3 subjects will be treated with placebo per cohort
CAT 1004Drug
Multiple dose oral administration once daily for 14 days of CAT 1004 at dose level 2 -9 subjects will be treated with CAT-1004
CAT 1004Drug
Multiple dose oral administration BID for 14 days of CAT 1004 at dose level 3-9 subjects will be treated with CAT-1004
CAT 1004Drug
Multiple dose oral administration BID for 14 days of CAT 1004 at dose level 4-9 subjects will be treated with CAT-1004
CAT 1004Drug
Multiple dose oral administration daily for 14 days of CAT 1004 at dose level TBD-9 subjects will be treated with CAT-1004
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Dose level 1 | Experimental | Multiple dose orally: CAT-1004 Dose level 1 or placebo Receives: Drug: CAT 1004; Drug: Placebo |
| Cohort 2: Dose level 2 | Experimental | Multiple dose orally: CAT-1004 Dose level 2 or placebo Receives: Drug: Placebo; Drug: CAT 1004 |
| Cohort 3: Dose level 3 | Experimental | Multiple dose orally: CAT-1004 Dose level 3 or placebo Receives: Drug: Placebo; Drug: CAT 1004 |
| Cohort 4: Dose level 4 | Experimental | Multiple dose orally: CAT-1004 Dose level 4 or placebo Receives: Drug: Placebo; Drug: CAT 1004 |
| Cohort 5: Dose level TBD | Experimental | Multiple dose orally: CAT-1004 Dose level TBD or placebo Receives: Drug: Placebo; Drug: CAT 1004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of adverse events
Measured: Screening to Follow-up (Day 25)
Secondary outcomes (7)
AUCinf of CAT-1004
Measured: Days 1, 7 and 14
Glucose area under the curve for 0-24 hrs/24 and 0-4 hrs/4
Measured: Day -2 through f/u (Day 25)
Cmax of CAT-1004
Measured: Days 1, 7 and 14
Changes from baseline for hematology, chemistry, coagulation and urinalysis
Measured: Baseline through End of study (Day 25)
Changes from baseline for Physical exams
Measured: Baseline through end of study (Day 25)
Changes from baseline for ECGs
Measured: Baseline through end of study (Day 25)
Changes from baseline in vital signs
Measured: Baseline through end of study (Day 25)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catabasis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joanne Donovan, M.D., PhD, Study director, Catabasis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511900
- Sponsor's protocol ID
- CAT 1004 102
- Status last verified
- Jun 2012
- First submitted
- 8 Jan 2012
- Last updated
- 8 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CAT-1004 in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01511900
- Acronym / sponsor ID
- CAT 1004 102
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Catabasis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 19 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate the safety of escalating multiple doses over 2 weeks of CAT 1004 compared to placebo in patients with Type 2 diabetes (T2D).
Secondary objectives include evaluation of the pharmacokinetics (PK) and pharmacodynamics of escalating multiple doses of CAT-1004 in patients with T2D.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Dose level 1 | Experimental | Drug: CAT 1004, Drug: PlaceboMultiple dose orally: CAT-1004 Dose level 1 or placebo |
| Cohort 2: Dose level 2 | Experimental | Drug: Placebo, Drug: CAT 1004Multiple dose orally: CAT-1004 Dose level 2 or placebo |
| Cohort 3: Dose level 3 | Experimental | Drug: Placebo, Drug: CAT 1004Multiple dose orally: CAT-1004 Dose level 3 or placebo |
| Cohort 4: Dose level 4 | Experimental | Drug: Placebo, Drug: CAT 1004Multiple dose orally: CAT-1004 Dose level 4 or placebo |
| Cohort 5: Dose level TBD | Experimental | Drug: Placebo, Drug: CAT 1004Multiple dose orally: CAT-1004 Dose level TBD or placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age between 18 to 65 years inclusive at Screening.
- Diagnosis of T2D:
- For Part I:
- For Part II:
- Satisfies one of the following:
Key exclusion criteria (10 listed)
- Use of prescription medications other than allowed medications within 30 days of planned admission to the clinic. Allowed medications include metformin, anti-hypertensives, lipid-lowering medications, thyroid replacement therapy, low-dose aspirin (81 mg/day), proton pump inhibitors and anti-depressants. Prescribed doses of these medications must have been stable for 2 months at the time of first dose.
- Clinically significant abnormalities in physical examination or vital signs at screening
- Clinically significant electrocardiogram (ECG) abnormalities as assessed by the investigator.
- Clinically significant laboratory result as assessed by the Investigator.
- The patient has a history of clinically significant medical disease including significant allergies (except for untreated, asymptomatic seasonal allergies at the time of dosing), or hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease, other than T2D, hypertension, dyslipidemia, hypothyroidism or depression.
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 |
|---|---|---|
| CAT 1004Multiple dose oral administration once daily for 14 days of CAT 1004 at dose level 1-9 subjects will be treated with CAT-1004 | Drug | Cohort 1: Dose level 1 |
| PlaceboMultiple dose oral administration of placebo daily for 14 days-3 subjects will be treated with placebo per cohort | Drug | Cohort 1: Dose level 1, Cohort 2: Dose level 2, Cohort 3: Dose level 3, Cohort 4: Dose level 4, Cohort 5: Dose level TBD |
| CAT 1004Multiple dose oral administration once daily for 14 days of CAT 1004 at dose level 2 -9 subjects will be treated with CAT-1004 | Drug | Cohort 2: Dose level 2 |
| CAT 1004Multiple dose oral administration BID for 14 days of CAT 1004 at dose level 3-9 subjects will be treated with CAT-1004 | Drug | Cohort 3: Dose level 3 |
| CAT 1004Multiple dose oral administration BID for 14 days of CAT 1004 at dose level 4-9 subjects will be treated with CAT-1004 | Drug | Cohort 4: Dose level 4 |
| CAT 1004Multiple dose oral administration daily for 14 days of CAT 1004 at dose level TBD-9 subjects will be treated with CAT-1004 | Drug | Cohort 5: Dose level TBD |
Primary outcome
Frequency and severity of adverse events
Time frame: Screening to Follow-up (Day 25)
7 secondary outcomes
AUCinf of CAT-1004
Time frame: Days 1, 7 and 14
Glucose area under the curve for 0-24 hrs/24 and 0-4 hrs/4
Time frame: Day -2 through f/u (Day 25)
Cmax of CAT-1004
Time frame: Days 1, 7 and 14
Changes from baseline for hematology, chemistry, coagulation and urinalysis
Time frame: Baseline through End of study (Day 25)
Changes from baseline for Physical exams
Time frame: Baseline through end of study (Day 25)
Changes from baseline for ECGs
Time frame: Baseline through end of study (Day 25)
Changes from baseline in vital signs
Time frame: Baseline through end of study (Day 25)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2012.
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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.
Joanne Donovan, M.D., PhD study director
Catabasis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CAT 1004 in people with Type 2 Diabetes, run by Catabasis Pharmaceuticals 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 12 inclusion and 10 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: finished, as of the sponsor's last update on 8 Jun 2012. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency and severity of adverse events (time frame: Screening to Follow-up (Day 25)). 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 8 Jun 2012.