A Multiple Ascending Dose Study of CAT-1004 in Patients With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01511900
• Other study ID #: CAT 1004 102
• Status: Completed
• Phase: Phase 1
• First received: January 8, 2012
• Last updated: June 7, 2012
• Start date: December 2011
• Est. completion date: April 2012

Study information

• Verified date: June 2012
• Source: Catabasis Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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 with T2D.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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.

• 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.

Exclusion Criteria:

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.

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• CAT 1004
Multiple dose oral administration once daily for 14 days of CAT 1004 at dose level 1-9 subjects will be treated with CAT-1004
• Placebo
Multiple dose oral administration of placebo daily for 14 days-3 subjects will be treated with placebo per cohort
• CAT 1004
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 1004
Multiple dose oral administration BID for 14 days of CAT 1004 at dose level 3-9 subjects will be treated with CAT-1004
• CAT 1004
Multiple dose oral administration BID for 14 days of CAT 1004 at dose level 4-9 subjects will be treated with CAT-1004
• CAT 1004
Multiple dose oral administration daily for 14 days of CAT 1004 at dose level TBD-9 subjects will be treated with CAT-1004

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Catabasis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and severity of adverse events		Screening to Follow-up (Day 25)	Yes
Secondary	AUCinf of CAT-1004		Days 1, 7 and 14	No
Secondary	Glucose area under the curve for 0-24 hrs/24 and 0-4 hrs/4		Day -2 through f/u (Day 25)	No
Secondary	Cmax of CAT-1004		Days 1, 7 and 14	No
Secondary	Changes from baseline for hematology, chemistry, coagulation and urinalysis		Baseline through End of study (Day 25)	Yes
Secondary	Changes from baseline for Physical exams		Baseline through end of study (Day 25)	Yes
Secondary	Changes from baseline for ECGs		Baseline through end of study (Day 25)	Yes
Secondary	Changes from baseline in vital signs		Baseline through end of study (Day 25)	Yes