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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01028963




Registration number
NCT01028963
Ethics application status
Date submitted
4/12/2009
Date registered
9/12/2009
Date last updated
25/08/2023

Titles & IDs
Public title
A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Type 2 Diabetes Mellitus
Scientific 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
Secondary ID [1] 0 0
CL004_140
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - pioglitazone
Treatment: Drugs - CCX140-B
Treatment: Drugs - CCX140-B

Placebo comparator: Placebo -

Active comparator: Active control -

Experimental: Active Study Medication (Group C) - CCX140-B

Experimental: Active Study Medication (Group D) - CCX140-B


Treatment: Drugs: Placebo
Placebo capsules once daily

Treatment: Drugs: pioglitazone
pioglitazone 30 mg tablet once daily

Treatment: Drugs: CCX140-B
CCX140-B capsules once daily (Group C)

Treatment: Drugs: CCX140-B
CCX140-B capsules once daily (Group D)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Subject incidence of adverse events
Timepoint [1] 0 0
28 days
Secondary outcome [1] 0 0
Effect on fasting plasma glucose concentration
Timepoint [1] 0 0
28 days

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2010
Sample size
Target
Accrual to date
Final
159
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
- Auchenflower
Recruitment hospital [2] 0 0
- Kippa-Ring
Recruitment postcode(s) [1] 0 0
- Auchenflower
Recruitment postcode(s) [2] 0 0
- Kippa-Ring
Recruitment outside Australia
Country [1] 0 0
Czechia
State/province [1] 0 0
Beroun
Country [2] 0 0
Czechia
State/province [2] 0 0
Hlucin
Country [3] 0 0
Czechia
State/province [3] 0 0
Neratovice
Country [4] 0 0
Czechia
State/province [4] 0 0
Novy Jicin
Country [5] 0 0
Czechia
State/province [5] 0 0
Ostrava
Country [6] 0 0
Czechia
State/province [6] 0 0
Pardubice
Country [7] 0 0
Czechia
State/province [7] 0 0
Prague
Country [8] 0 0
Czechia
State/province [8] 0 0
Prelouc
Country [9] 0 0
Czechia
State/province [9] 0 0
Slany
Country [10] 0 0
Czechia
State/province [10] 0 0
Uhersky Brod
Country [11] 0 0
Czechia
State/province [11] 0 0
Unicov
Country [12] 0 0
Czechia
State/province [12] 0 0
Usti nad Labem
Country [13] 0 0
Germany
State/province [13] 0 0
Basenheim
Country [14] 0 0
Germany
State/province [14] 0 0
Berlin
Country [15] 0 0
Germany
State/province [15] 0 0
Cologne
Country [16] 0 0
Germany
State/province [16] 0 0
Dresden
Country [17] 0 0
Germany
State/province [17] 0 0
Heidelberg
Country [18] 0 0
Germany
State/province [18] 0 0
Mannheim
Country [19] 0 0
Germany
State/province [19] 0 0
Nuremberg
Country [20] 0 0
Germany
State/province [20] 0 0
Saarlouis
Country [21] 0 0
Hungary
State/province [21] 0 0
Balatonfuered
Country [22] 0 0
Hungary
State/province [22] 0 0
Budapest
Country [23] 0 0
Hungary
State/province [23] 0 0
Satoraljaujhely
Country [24] 0 0
Hungary
State/province [24] 0 0
Szikszo
Country [25] 0 0
New Zealand
State/province [25] 0 0
Christchurch
Country [26] 0 0
New Zealand
State/province [26] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ChemoCentryx
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pirow MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01028963