A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Type 2 Diabetes Mellitus
This study has been completed.
Sponsor:
ChemoCentryx
Information provided by (Responsible Party):
ChemoCentryx
ClinicalTrials.gov Identifier:
NCT01028963
First received: December 4, 2009
Last updated: February 8, 2012
Last verified: February 2012
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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
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 May 16, 2013