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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01028963
• Other study ID #: CL004_140
• Status: Completed
• Phase: Phase 2
• Start date: January 2010
• Est. completion date: November 2010

Study information

• Verified date: August 2023
• Source: ChemoCentryx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

The primary objective of this study is to evaluate the safety and tolerability of CCX140-B in subjects with Type 2 diabetes mellitus (T2DM) based on subject incidence of adverse events.

The secondary objectives of this study include evaluation of the effect of CCX140-B on several measures of effectiveness commonly used in the evaluation of diabetes medications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: November 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Key Inclusion Criteria:

• Diagnosed type 2 diabetes mellitus

• Must have a body mass index =25 and <45 kg/m2, but if body mass index is =25 and <28 kg/m2, 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

Key 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

• Symptomatic congestive heart failure requiring prescription medication, clinically evident peripheral edema, poorly-controlled hypertension (systolic blood pressure >160 or diastolic blood pressure >100), history of unstable angina, 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 (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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Placebo
Placebo capsules once daily
• pioglitazone
pioglitazone 30 mg tablet once daily
• CCX140-B
CCX140-B capsules once daily (Group C)
• CCX140-B
CCX140-B capsules once daily (Group D)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ChemoCentryx

Countries where clinical trial is conducted

Australia,  Czechia,  Germany,  Hungary,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject incidence of adverse events		28 days
Secondary	Effect on fasting plasma glucose concentration		28 days