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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Placebo; Drug: pioglitazone; Drug: CCX140-B; Drug: CCX140-B

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.

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Auchenflower, Queensland, Australia
    • Kippa-Ring, Queensland, Australia
• Czechia
  • Beroun, Czechia
  • Hlucin, Czechia
  • Neratovice, Czechia
  • Novy Jicin, Czechia
  • Ostrava, Czechia
  • Pardubice, Czechia
  • Prague, Czechia
  • Prelouc, Czechia
  • Slany, Czechia
  • Uhersky Brod, Czechia
  • Unicov, Czechia
  • Usti nad Labem, Czechia
• Germany
  • Basenheim, Germany
  • Berlin, Germany
  • Cologne, Germany
  • Dresden, Germany
  • Heidelberg, Germany
  • Mannheim, Germany
  • Nuremberg, Germany
  • Saarlouis, Germany
• Hungary
  • Balatonfuered, Hungary
  • Budapest, Hungary
  • Satoraljaujhely, Hungary
  • Szikszo, Hungary
• New Zealand
  • Christchurch, New Zealand
  • Wellington, New Zealand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo capsules once daily
Active Comparator: Active control	Drug: pioglitazone; pioglitazone 30 mg tablet once daily
Experimental: Active Study Medication (Group C); CCX140-B	Drug: CCX140-B; CCX140-B capsules once daily (Group C); Drug: CCX140-B; CCX140-B capsules once daily (Group D)
Experimental: Active Study Medication (Group D); CCX140-B	Drug: CCX140-B; CCX140-B capsules once daily (Group C); Drug: CCX140-B; CCX140-B capsules once daily (Group D)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Subject incidence of adverse events	28 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: December 4, 2009
• First Submitted That Met QC Criteria: December 8, 2009
• First Posted (Estimated): December 9, 2009

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus; Physiological Effects of Drugs; Hypoglycemic Agents; Pioglitazone
• Other Study ID Numbers: CL004_140