The safety and efficacy of CCX140-B in subjects with type 2 diabetes

Phase 2

Completed

• Conditions: Type 2 diabetes mellitus; Nutritional, Metabolic, Endocrine; Non-insulin-dependent diabetes mellitus

• Registration Number: ISRCTN54010405
• Lead Sponsor: ChemoCentryx, Inc. (USA)

Brief Summary

2012 results in: https://www.omicsonline.org/orally-administered-chemokine-receptor-ccr-antagonist-ccxb-in-type-diabetes-2155-6156.1000225.php?aid=10223 [added 20/02/2019]

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-11
• Study Completion: 2010-08-30
• Last Update Posted: 18 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. Male, post-menopausal (at least 2 years) or surgically sterile female subjects, aged 18 - 70 years inclusive, with type 2 diabetes mellitus
2. Must have a body mass index greater than or equal to 25 and less than 45 kg/m^2, but if body mass index is greater than or equal to 25 and less than 28 kg/m^2, then waist circumference must be greater then 94 cm for men and greater than 80 cm for women
3. Must be on a stable dose of metformin for at least 8 weeks prior to randomisation
4. Haemoglobin A1c (HbA1c) of 6.5 to 10.0% inclusive and fasting plasma glucose 135 to 270 mg/dL inclusive at screening

Exclusion Criteria

1. Type 1 diabetes mellitus or history of diabetic ketoacidosis
2. Received insulin treatment within 12 weeks of randomisation
3. Received chronic (more than 7 days) systemic glucocorticoid treatment within 12 weeks of randomisation
4. Received sulfonylurea, thiazolidinedione, exenatide, or any other glucose lowering treatment (other than metformin) within 8 weeks of randomisation
5. Symptomatic congestive heart failure requiring prescription medication, clinically evident peripheral oedema, poorly-controlled hypertension (systolic blood pressure greater than 160 or diastolic blood pressure greater than 100), history of unstable angina, myocardial infarction or stroke within 6 months of randomisation, or chronic renal failure
6. History or presence of drug-induced myopathy, drug-induced creatine kinase elevation, or leukopaenia (white blood cell [WBC] count less than 3.5 x 10^9/L)
7. History or presence of any form of cancer within the 5 years prior to randomisation, 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
8. Fasting serum triglyceride greater than 400 mg/dL

Study & Design

• Study Type: Interventional
• Study Design: Not specified