Document Detail


Black/African American patients with type 2 diabetes mellitus: study design and baseline patient characteristics from a randomized clinical trial of linagliptin.
MedLine Citation:
PMID:  23134211     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: In the United States, black/African American individuals are more likely than whites to develop type 2 diabetes mellitus (T2DM), and have higher rates of complications, but are under-represented in clinical trials. The design of a trial comparing the efficacy and safety of the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin 5 mg/day with placebo in this patient group, and the characteristics of the patients enrolled are reported.
RESEARCH DESIGN AND METHODS: This United States, multicenter, 24-week, randomized, double-blind study enrolled adults with T2DM who self-reported their race as black or African American, were receiving ≤ 1 oral antidiabetes drug, had a body mass index ≤ 45 kg/m(2) and glycosylated hemoglobin (HbA(1c)) of 7.5 - 11% at screening.
MAIN OUTCOME MEASURES: The primary efficacy endpoint is the change of HbA(1c) from baseline to week 24.
BASELINE DATA: A total of 226 patients were randomized and received ≥ 1 study drug dose. The mean age was 54 years (standard deviation: 9.9 years), and 54% were men. The mean HbA(1c) was 8.75% (standard deviation: 1.10%). Approximately half the patients (52%) had mild or moderate renal impairment and the majority (72%) had hypertension.
CONCLUSIONS: To the authors' knowledge, this is the first trial of any oral antidiabetes drug specifically conducted in black/African American patients.
Authors:
James Thrasher; Kristen Daniels; Sanjay Patel; Jacqueline Whetteckey
Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2012-11-08
Journal Detail:
Title:  Expert opinion on pharmacotherapy     Volume:  13     ISSN:  1744-7666     ISO Abbreviation:  Expert Opin Pharmacother     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-11-12     Completed Date:  2013-04-18     Revised Date:  2013-11-06    
Medline Journal Info:
Nlm Unique ID:  100897346     Medline TA:  Expert Opin Pharmacother     Country:  England    
Other Details:
Languages:  eng     Pagination:  2443-52     Citation Subset:  IM    
Affiliation:
Medical Investigations, Inc., Little Rock, AR 72205, USA. jthrashermd@yahoo.com
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT01194830
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MeSH Terms
Descriptor/Qualifier:
Adult
African Americans
Aged
Aged, 80 and over
Diabetes Mellitus, Type 2 / drug therapy*
Dipeptidyl-Peptidase IV Inhibitors / therapeutic use*
Double-Blind Method
Female
Humans
Male
Middle Aged
Purines / therapeutic use*
Quinazolines / therapeutic use*
Treatment Outcome
Young Adult
Chemical
Reg. No./Substance:
0/Dipeptidyl-Peptidase IV Inhibitors; 0/Purines; 0/Quinazolines; 3X29ZEJ4R2/Linagliptin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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