PMID- 23134211
OWN - NLM
STAT- MEDLINE
DCOM- 20130418
LR  - 20221207
IS  - 1744-7666 (Electronic)
IS  - 1465-6566 (Linking)
VI  - 13
IP  - 17
DP  - 2012 Dec
TI  - Black/African American patients with type 2 diabetes mellitus: study design and 
      baseline patient characteristics from a randomized clinical trial of linagliptin.
PG  - 2443-52
LID - 10.1517/14656566.2012.740459 [doi]
AB  - 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.
FAU - Thrasher, James
AU  - Thrasher J
AD  - Medical Investigations, Inc., Little Rock, AR 72205, USA. jthrashermd@yahoo.com
FAU - Daniels, Kristen
AU  - Daniels K
FAU - Patel, Sanjay
AU  - Patel S
FAU - Whetteckey, Jacqueline
AU  - Whetteckey J
LA  - eng
SI  - ClinicalTrials.gov/NCT01194830
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20121108
PL  - England
TA  - Expert Opin Pharmacother
JT  - Expert opinion on pharmacotherapy
JID - 100897346
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Purines)
RN  - 0 (Quinazolines)
RN  - 3X29ZEJ4R2 (Linagliptin)
SB  - IM
MH  - Adult
MH  - Black or African American
MH  - Aged
MH  - Aged, 80 and over
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Dipeptidyl-Peptidase IV Inhibitors/*therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Linagliptin
MH  - Male
MH  - Middle Aged
MH  - Purines/*therapeutic use
MH  - Quinazolines/*therapeutic use
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2012/11/09 06:00
MHDA- 2013/04/20 06:00
CRDT- 2012/11/09 06:00
PHST- 2012/11/09 06:00 [entrez]
PHST- 2012/11/09 06:00 [pubmed]
PHST- 2013/04/20 06:00 [medline]
AID - 10.1517/14656566.2012.740459 [doi]
PST - ppublish
SO  - Expert Opin Pharmacother. 2012 Dec;13(17):2443-52. doi: 
      10.1517/14656566.2012.740459. Epub 2012 Nov 8.