A Study to Evaluate the Safety and Efficacy of CCX140-B i... | NCT01028963

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Oct 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Dec 4, 2009

First Submission Date that Met QC Criteria

Dec 8, 2009

First Posted Date

Dec 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2025

Last Update Posted Date

Mar 6, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

159Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Drug: Placebo
Active control	Active Comparator		Drug: pioglitazone
Active Study Medication (Group C)	Experimental	CCX140-B	Drug: CCX140-B
Active Study Medication (Group D)	Experimental	CCX140-B	Drug: CCX140-B

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Placebo capsules once daily	Placebo
pioglitazone

Measure	Description	Time Frame
Subject incidence of adverse events		28 days

Measure	Description	Time Frame
Effect on fasting plasma glucose concentration		28 days

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Auchenflower	Queensland		Australia

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D000077205	Pioglitazone
C585356	CCX140-B

ID	Term
D045162	Thiazolidinediones
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds