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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

ChemoCentryx

ClinicalTrials.gov Identifier:

NCT01028963

First received: December 4, 2009

Last updated: February 8, 2012

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 4, 2009

Last Updated Date

February 8, 2012

Start Date ^ICMJE

January 2010

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Subject incidence of adverse events [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01028963 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Effect on fasting plasma glucose concentration [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Type 2 Diabetes Mellitus

Intervention ^ICMJE

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

Study Arm (s)

Placebo Comparator: Placebo
Intervention: Drug: Placebo
Active Comparator: Active control
Intervention: Drug: pioglitazone
Experimental: Active Study Medication (Group C)
CCX140-B

Intervention: Drug: CCX140-B
Experimental: Active Study Medication (Group D)
CCX140-B

Intervention: Drug: CCX140-B

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

159

Completion Date

November 2010

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia, Czech Republic, Germany, Hungary, New Zealand

Administrative Information

NCT Number ^ICMJE

NCT01028963

Other Study ID Numbers ^ICMJE

CL004_140

Has Data Monitoring Committee

Yes

Responsible Party

ChemoCentryx

Study Sponsor ^ICMJE

ChemoCentryx

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pirow Bekker, MD, PhD

ChemoCentryx, Inc.

Information Provided By

ChemoCentryx

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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