title: Diurnal glucose profiles using continuous glucose monitoring to identify the glucose-lowering characteristics of colesevelam HCl (Welchol).
abstract: OBJECTIVE
  The study's purpose was to identify the antihyperglycemic affects of colesevelam-HCl (C-HCl) by characterizing the diurnal and postprandial glucose patterns in type 2 diabetic subjects treated concomitantly with metformin, sulfonylurea, or a combination of metformin/sulfonylurea. A secondary aim was to determine whether C-HCl significantly increased the risk of hypoglycemia.
  
  
  METHODS
  A prospective, randomized, double-blind, placebo-controlled, crossover study employing continuous glucose monitoring (CGM) with ambulatory glucose profile (AGP) analysis was undertaken. Fifteen males and 6 females, age 60 ± 8 years, treated with metformin (n = 8), sulfonylurea (n = 2), or combination (n = 11) participated.
  
  
  RESULTS
  Treatment with C-HCl led to reductions in glycated hemoglobin (HbA1c) (7.5 ± 0.3 to 7.0 ± 0.4% P<.0001), LDL (90.9 ± 18.6 to 68.9 ± 15.2 mg/dL, P<.0007) and total cholesterol (169.2 ± 24.4 to 147.8 ± 21.5 mg/dL, P<.001). Significantly lower normalized diurnal (21 mg/dL/hour, P = .0006), nocturnal (19 mg/dL/hour, P = .0005), and daytime (22 mg/dL/hour, P = .0008) glucose exposure was detected immediately upon C-HCl administration. Additionally, there was a significant (P<.004) decline in postprandial glucose excursions (averaging 15% or -36 mg/dL/hour) pronounced at dinner following C-HCl administration. There was a nonsignificant increase in the incidence of hypoglycemia (0.4-1%), with no difference due to antihyperglycemic medications.
  
  
  CONCLUSIONS
  AGP analysis of CGM visually and quantitatively showed immediate and midterm impacts of C-HCl on basal and postprandial glucose patterns. This suggests a multifactorial glucose-lowering mechanism for C-HCl affecting both meal-related and basal glucose levels.
authors.affiliation: International Diabetes Center, and Mayo Clinic, WHO Collaborating Center, Minneapolis, MN 55331, USA. rmazze@aol.com
authors.forename: Roger S
authors.initials: RS
authors.lastname: Mazze
authors.forename: Ellie S
authors.initials: ES
authors.lastname: Strock
authors.forename: Arlene M
authors.initials: AM
authors.lastname: Monk
authors.forename: Matthew M
authors.initials: MM
authors.lastname: Murphy
authors.forename: Min
authors.initials: M
authors.lastname: Xi
authors.forename: Richard M
authors.initials: RM
authors.lastname: Bergenstal
mesh_terms: D000368:Aged; D000499:Allylamine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000924:Anticholesteremic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001786:Blood Glucose / Q000032:analysis*; D002940:Circadian Rhythm; D000069472:Colesevelam Hydrochloride; D018592:Cross-Over Studies; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications* / Q000188:drug therapy; D004311:Double-Blind Method; D004347:Drug Interactions; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D007003:Hypoglycemia / Q000139:chemically induced / Q000453:epidemiology / Q000517:prevention & control*; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use; D015994:Incidence; D008297:Male; D008687:Metformin / Q000627:therapeutic use; D008875:Middle Aged; D008910:Minnesota / Q000453:epidemiology; D018670:Monitoring, Ambulatory; D013453:Sulfonylurea Compounds / Q000627:therapeutic use
chemical_list: D000924:Anticholesteremic Agents; D001786:Blood Glucose; D007004:Hypoglycemic Agents; D013453:Sulfonylurea Compounds; D000499:Allylamine; D008687:Metformin; D000069472:Colesevelam Hydrochloride