Type 2 Diabetes Mellitus in subjects with insufficient glycemic control on a stable dose of metformin MedDRA version: 12.0 Level: LLT Classification code 10067585 Term: Type 2 diabetes mellitus
Conditions
Interventions
Product Name: CCX140-B
Product Code: CCX140-B
Pharmaceutical Form: Capsule, hard
CAS Number: 1100319-36-5
Current Sponsor code: CCX140-B
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
ChemoCentryx, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male, postmenopausal (at least 2 years) or surgically sterile female subjects, aged 18-70 years inclusive, with type 2 diabetes mellitus; Male subjects with partners of childbearing potential may participate in the study if they had a vasectomy at least 6 months prior to randomization or they are using double-barrier contraception or barrier-method plus another method of contraception and continue to use one of these contraceptive methods throughout the study period; 2. Must have a body mass index =25 and 94 cm for men and >80 cm for women; 3. Must be on a stable dose of metformin for at least 8 weeks prior to randomization; 4. If on lipid lowering agents, must be on stable doses for at least 4 weeks prior to randomization; 5. If on thyroid replacement therapy, the subject must be on a stable dose for at least 6 weeks prior to randomization, and the thyroid stimulating hormone (TSH) level must not be > 1.5 x upper limit of normal; 6. HbA1c of 6.5 to 10.0% inclusive and fasting plasma glucose 135 to 270 mg/dL inclusive at Screening; 7. Willing and able to give written Informed Consent and to comply with the requirements of the study protocol; and 8. Judged to be otherwise healthy by the Investigator, based on medical history, physical examination (including electrocardiogram [ECG]), and clinical laboratory assessments. Subjects with clinical laboratory values that are outside of normal limits (other than those specified in the Exclusion Criteria) and/or with other abnormal clinical findings that are judged by the Investigator not to be of clinical significance, may be entered into the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes mellitus or history of diabetic ketoacidosis or other severe secondary diseases related to diabetes such as diabetic retinopathy, nephropathy, or diabetic foot; 2. Received insulin treatment within 12 weeks of randomization; 3. Received chronic (more than 7 days) systemic glucocorticoid treatment within 12 weeks of randomization; 4. Received sulfonylurea, thiazolidinedione, exenatide, or any other glucose lowering treatment (other than metformin) within 8 weeks of randomization; 5. Cardiac failure or history of cardiac failure (New York Heart Association [NYHA] stages I to IV), clinically evident peripheral edema, poorly-controlled hypertension (systolic blood pressure >160 or diastolic blood pressure >100), history of unstable angina, symptomatic coronary artery disease, myocardial infarction or stroke within 6 months of randomization, or chronic renal failure; 6. History of hypersensitivity or intolerance to any thiazolidinedione or to other peroxisome proliferator-activated receptor (PPAR) agonists, ingredients of the placebo (tartrazine, microcrystalline cellulose, starch, or croscarmellose sodium), or have previously received the active ingredient, CCX140-B; 7. History or presence of drug-induced myopathy, drug-induced creatine kinase elevation, or leukopenia (WBC count 2 x the upper limit of normal; 15. Evidence of renal impairment; serum creatinine = 1.4 mg/dL for women or = 1.5 mg/dL for men, or estimated Glomerular Filtration Rate (GFR) based on the Cockcroft-Gault equation 400 mg/dL; 17. Clinically significant abnormal ECG during screening, e.g., QTc greater than 450 msec; 18. Participated in any clinical study of an investigational product within 30 days prior to randomization; and 19. History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the subject at unacceptable risk for study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the safety and tolerabililty of CCX140-B in subjects with Type 2 diabetes mellitus (T2DM) based on incidence of adverse events ;Secondary Objective: Evaluation of the effect of CCX140-B, compared to placebo, on: 1. Fasting plasma glucose concentrations; 2. Glucose tolerance, measured by an oral glucose tolerance test (OGTT); 3. Homeostasis model assessment of insulin resistance (HOMA-IR); 4. Fasting plasma insulin concentrations; 5. Glucose control based on HbA1c and fasting plasma fructosamine concentrations; 6. Serum total adiponectin concentrations; 7. Plasma monocyte chemoattractant protein-1 (MCP-1) concentrations; 8. Serum high sensitivity C-reactive protein (hsCRP) concentrations; 9. Serum lipid concentrations, including total cholesterol, high density lipoprotein-cholesterol (HDL-C), low density lipoprotein-cholesterol (LDL-C), triglycerides, and non-esterified fatty acids (NEFAs); ;Primary end point(s): Subject incidence of adverse events. | — |
Countries
Czech Republic, Germany, Hungary
Outcome results
None listed