PMID- 18852398
OWN - NLM
STAT- MEDLINE
DCOM- 20081028
LR  - 20221207
IS  - 1538-3679 (Electronic)
IS  - 0003-9926 (Linking)
VI  - 168
IP  - 18
DP  - 2008 Oct 13
TI  - Colesevelam hydrochloride therapy in patients with type 2 diabetes mellitus 
      treated with metformin: glucose and lipid effects.
PG  - 1975-83
LID - 10.1001/archinte.168.18.1975 [doi]
AB  - BACKGROUND: Bile acid sequestrants are a well-accepted class of 
      cholesterol-lowering drugs. Over the last decade, small studies have indicated 
      that these agents may also lower glucose levels in patients with type 2 diabetes 
      mellitus (T2DM). METHODS: This 26-week, randomized, double-blind, 
      placebo-controlled, parallel-group study was conducted between August 2004 and 
      July 2006 at 54 sites in the United States and 2 in Mexico to determine the 
      effects of colesevelam hydrochloride, a bile acid sequestrant, in patients with 
      inadequately controlled T2DM (hemoglobin A(1c) [HbA(1c)] level, 7.5%-9.5% 
      [baseline HbA(1c) level, 8.1%]), who were receiving metformin monotherapy or 
      metformin combined with additional oral anti-diabetes mellitus drugs. In total, 
      316 subjects were randomized (159 to colesevelam hydrochloride, 3.75 g/d, and 157 
      to matching placebo). The primary efficacy parameter was mean placebo-corrected 
      change in HbA(1c) level from baseline to week 26 (analysis was on an 
      intent-to-treat population using a last-observation-carried-forward approach). 
      RESULTS: Colesevelam lowered the mean HbA(1c) level compared with placebo at week 
      26 (-0.54%; P < .001). Similar results were observed in the metformin monotherapy 
      (-0.47%; P = .002) and combination therapy cohorts (-0.62%; P < .001). In 
      addition, colesevelam significantly (1) lowered fasting plasma glucose (-13.9 
      mg/dL P = .01), fructosamine (-23.2 micromol/L; P < .001), total cholesterol (TC) 
      (-7.2%; P < .001), low-density lipoprotein cholesterol (LDL-C) (-15.9%; P < 
      .001), apolipoprotein B (-7.9%; P < .001), non-high-density lipoprotein 
      cholesterol (HDL-C) (-10.3%; P < .001), and high-sensitivity C-reactive protein 
      (-14.4%; P = .02) levels and (2) improved other measures of glycemic response, as 
      well as TC/HDL-C, LDL-C/HDL-C, non-HDL-C/HDL-C, and apolipoprotein 
      B/apolipoprotein A-I ratios (P < .003 for all). Triglyceride, HDL-C, and 
      apolipoprotein A-I levels were not statistically significantly increased. 
      CONCLUSION: Colesevelam improves glycemic and lipid parameters in patients with 
      T2DM inadequately controlled with metformin-based therapy.
FAU - Bays, Harold E
AU  - Bays HE
AD  - Louisville Metabolic and Atherosclerosis Research Center Inc, 3288 Illinois Ave, 
      Louisville, KY 40213, USA. hbaysmd@aol.com
FAU - Goldberg, Ronald B
AU  - Goldberg RB
FAU - Truitt, Kenneth E
AU  - Truitt KE
FAU - Jones, Michael R
AU  - Jones MR
LA  - eng
SI  - ClinicalTrials.gov/NCT00147719
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Arch Intern Med
JT  - Archives of internal medicine
JID - 0372440
RN  - 0 (Anticholesteremic Agents)
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Lipids)
RN  - 48G762T011 (Allylamine)
RN  - 9100L32L2N (Metformin)
RN  - P4SG24WI5Q (Colesevelam Hydrochloride)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Allylamine/*analogs & derivatives/therapeutic use
MH  - Anticholesteremic Agents/therapeutic use
MH  - Blood Glucose/*drug effects/metabolism
MH  - Colesevelam Hydrochloride
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Follow-Up Studies
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Hypoglycemic Agents/therapeutic use
MH  - Lipids/*blood
MH  - Male
MH  - Metformin/*therapeutic use
MH  - Middle Aged
MH  - Retrospective Studies
MH  - Treatment Outcome
EDAT- 2008/10/15 09:00
MHDA- 2008/10/29 09:00
CRDT- 2008/10/15 09:00
PHST- 2008/10/15 09:00 [pubmed]
PHST- 2008/10/29 09:00 [medline]
PHST- 2008/10/15 09:00 [entrez]
AID - 168/18/1975 [pii]
AID - 10.1001/archinte.168.18.1975 [doi]
PST - ppublish
SO  - Arch Intern Med. 2008 Oct 13;168(18):1975-83. doi: 10.1001/archinte.168.18.1975.