Clinical trial NCT01028963: A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Type 2 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2009-12-09
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Subject incidence of adverse events
timeFrame: 28 days
Secondary outcomes:
measure: Effect on fasting plasma glucose concentration
timeFrame: 28 days
Other outcomes:
Locations:
city: Auchenflower
country: Australia
state: Queensland
city: Kippa-Ring
country: Australia
state: Queensland
city: Beroun
country: Czechia
city: Hlucin
country: Czechia
city: Neratovice
country: Czechia
city: Novy Jicin
country: Czechia
city: Ostrava
country: Czechia
city: Pardubice
country: Czechia
city: Prague
country: Czechia
city: Prelouc
country: Czechia
city: Slany
country: Czechia
city: Uhersky Brod
country: Czechia
city: Unicov
country: Czechia
city: Usti nad Labem
country: Czechia
city: Basenheim
country: Germany
city: Berlin
country: Germany
city: Cologne
country: Germany
city: Dresden
country: Germany
city: Heidelberg
country: Germany
city: Mannheim
country: Germany
city: Nuremberg
country: Germany
city: Saarlouis
country: Germany
city: Balatonfuered
country: Hungary
city: Budapest
country: Hungary
city: Satoraljaujhely
country: Hungary
city: Szikszo
country: Hungary
city: Christchurch
country: New Zealand
city: Wellington
country: New Zealand
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: