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

NCT01028963 | Completed Phase 2 DMC

• 1 other identifier: CL004_140
• Study Type: interventional
• Target: 159
• Locations: 5 countries
• Sites: 28

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Subject incidence of adverse events

  28 days

Secondary Outcomes (1)

• Effect on fasting plasma glucose concentration

  28 days

Study Arms (4)

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

Placebo DRUG

Placebo capsules once daily

Placebo

pioglitazone DRUG

pioglitazone 30 mg tablet once daily

Active control

CCX140-B DRUG

CCX140-B capsules once daily (Group C)

Active Study Medication (Group C)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (28)

Unknown Facility

Auchenflower, Queensland, Australia

Location

Unknown Facility

Kippa-Ring, Queensland, Australia

Location

Unknown Facility

Beroun, Czechia

Location

Unknown Facility

Hlučín, Czechia

Location

Unknown Facility

Neratovice, Czechia

Location

Unknown Facility

Nový Jičín, Czechia

Location

Unknown Facility

Ostrava, Czechia

Location

Unknown Facility

Pardubice, Czechia

Location

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Přelouč, Czechia

Location

Unknown Facility

Slaný, Czechia

Location

Unknown Facility

Uherský Brod, Czechia

Location

Unknown Facility

Uničov, Czechia

Location

Unknown Facility

Ústí nad Labem, Czechia

Location

Unknown Facility

Basenheim, Germany

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Cologne, Germany

Location

Unknown Facility

Dresden, Germany

Location

Unknown Facility

Heidelberg, Germany

Location

Unknown Facility

Mannheim, Germany

Location

Unknown Facility

Nuremberg, Germany

Location

Unknown Facility

Saarlouis, Germany

Location

Unknown Facility

Balatonfüred, Hungary

Location

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Budapest, Hungary

Location

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Sátoraljaújhely, Hungary

Location

Unknown Facility

Szikszó, Hungary

Location

Unknown Facility

Christchurch, New Zealand

Location

Unknown Facility

Wellington, New Zealand

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Pioglitazone; CCX140-B

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2009
• First Posted: December 9, 2009
• Study Start: January 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2010
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

CZ (12); DE (8); HU (4); NZ (2); AU (2)