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
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Placebo
Drug: pioglitazone
Drug: CCX140-B
Phase 2

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

Resource links provided by NLM:


Further study details as provided by ChemoCentryx:

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

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

Enrollment: 159
Study Start Date: January 2010
Study Completion Date: November 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Experimental: Active Study Medication (Group D)
CCX140-B
Drug: CCX140-B
CCX140-B capsules once daily (Group D)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028963

Locations
Australia, Queensland
Auchenflower, Queensland, Australia
Kippa-Ring, Queensland, Australia
Czech Republic
Beroun, Czech Republic
Hlucin, Czech Republic
Neratovice, Czech Republic
Novy Jicin, Czech Republic
Ostrava, Czech Republic
Pardubice, Czech Republic
Prague, Czech Republic
Prelouc, Czech Republic
Slany, Czech Republic
Uhersky Brod, Czech Republic
Unicov, Czech Republic
Usti nad Labem, Czech Republic
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
Sponsors and Collaborators
ChemoCentryx
Investigators
Study Director: Pirow Bekker, MD, PhD ChemoCentryx, Inc.
  More Information

No publications provided

Responsible Party: ChemoCentryx
ClinicalTrials.gov Identifier: NCT01028963     History of Changes
Other Study ID Numbers: CL004_140
Study First Received: December 4, 2009
Last Updated: February 8, 2012
Health Authority: Australia: Therapeutic Goods Administration
Czech Republic: State Institute for Drug Control
New Zealand: Medsafe
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014