A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with Type 2 Diabetes Mellitus

A Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with Type 2 Diabetes Mellitus

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000400066

Enrollment

140

Registered

2010-05-18

Start date

2010-01-29

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to evaluate the safety and potential effectiveness of CCX140-B in subjects with type 2 diabetes mellitus.

Interventions

CCX140-B capsules 5 mg once daily for 28 days (Group C); CCX140-B capsules 10 mg once daily for 28 days (Group D)

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Diagnosed type 2 diabetes mellitus; must have body mass index greater than or equal to 25 and <45 kg/m2, but if body mass index is greater than or equal to 25 and <28, then waist circumference must be >94 cm for men and >80 cm for women; must be on a stable dose of metformin for at least 8 weeks prior to randomization; Hemoglobin A1c (HbA1c) of 6.5% to 10.0% inclusive and fasting plasma glucose 135 to 270 mg/dL inclusive at Screening

Exclusion criteria

Type 1 diabetes mellitus or history of diabetic ketoacidosis; received insulin treatment within 12 weeks of randomization; received chronic (more than 7 days) systemic glucocorticoid treatment within 12 weeks of randomization; received sulfonylurea, thiazolidinedione, exenatide or any other glucose lowering treatment (other than metformin) within 8 weeks of randomization; cardiac failure or history of cardiac failure (New York Heart Association [NYHA] stages I to IV), clinically evident peripheral edema, poorly controlled hypertension, history of unstable angina, syptomatic coronary artery disease, myocardial infarction or stroke within 6 months of randomization, or chronic renal failure; history or presence of drug-induced myopathy, drug-induced creatine kinase elevation, or leukopenia (white blood cell [WBC] count <3.5 x 10(9)/L); history or presence of any form of cancer within the 5 years prior to randomization, with the exception of excised basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ or breast carcinoma in situ that has been excised or resected completely and is without evidence of local recurrence or metastasis; fasting serum triglyceride >400 mg/dL

Outcome results