Initial combination therapy with metformin and colesevelam for achievement of glycemic and lipid goals in early type 2 diabetes.

Julio Rosenstock, Vivian A. Fonseca, W. Timothy Garvey, Ronald B Goldberg, Yehuda Handelsman, Stacey L. Abby, Yu Ling Lai, Xiaoping Jin, Soamnauth Misir, Sukumar Nagendran, Michael R. Jones

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Abstract

To evaluate the efficacy and safety of initial combination therapy with metformin plus colesevelam in patients with early type 2 diabetes. In this 16-week, randomized, double-blind, placebo-controlled study, adults with type 2 diabetes (hemoglobin A1c [A1C] values of 6.5% to 10.0%) and hypercholesterolemia (low-density lipoprotein cholesterol [LDL-C] levels > or =100 mg/dL) were randomly assigned (1:1) to colesevelam (3.75 g/d) or placebo in combination with open-label metformin (850 mg/d; uptitrated at week 2 to 1,700 mg/d). The primary efficacy evaluation was change in A1C from baseline to study end (week 16 with last observation carried forward). In total, 286 patients were randomized: metformin/colesevelam (n = 145) or metformin/placebo (n = 141). Mean A1C was reduced by 1.1% with metformin/colesevelam (from 7.8% at baseline to 6.6% at study end) and by 0.8% with metformin/placebo (from 7.5% to 6.7%), resulting in a treatment difference of -0.3% at study end (P = .0035). In addition, metformin/colesevelam significantly reduced LDL-C (-16.3%), total cholesterol (-6.1%), non-high-density lipoprotein cholesterol (-8.3%), apolipoprotein B (-8.0%), and high-sensitivity C-reactive protein (-17%) and increased apolipoprotein A-I (+4.4%) and triglycerides (+18.6%) versus metformin/placebo (P<.01 for all). The proportions of patients who achieved recommended goals with metformin/colesevelam versus metformin/placebo, respectively, were as follows: A1C <7.0% (67% versus 56% [P = .0092]), LDL-C <100 mg/dL (48% versus 18% [P<.0001]), and composite A1C <7.0% + LDL-C <100 mg/dL (40% versus 12% [P<.0001]). Safety and tolerability were similar between the treatment groups. Metformin plus colesevelam may be a valid option for initial therapy to achieve glycemic and lipid goals safely in early type 2 diabetes.

Original languageEnglish
Pages (from-to)629-640
Number of pages12
JournalEndocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists
Volume16
Issue number4
StatePublished - Jul 1 2010
Externally publishedYes

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Metformin
Type 2 Diabetes Mellitus
Lipids
Placebos
LDL Cholesterol
Therapeutics
Colesevelam Hydrochloride
Safety
Apolipoprotein A-I
Apolipoproteins B
Hypercholesterolemia
C-Reactive Protein
Hemoglobins
Triglycerides
Cholesterol
Observation

ASJC Scopus subject areas

  • Medicine(all)

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Initial combination therapy with metformin and colesevelam for achievement of glycemic and lipid goals in early type 2 diabetes. / Rosenstock, Julio; Fonseca, Vivian A.; Garvey, W. Timothy; Goldberg, Ronald B; Handelsman, Yehuda; Abby, Stacey L.; Lai, Yu Ling; Jin, Xiaoping; Misir, Soamnauth; Nagendran, Sukumar; Jones, Michael R.

In: Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists, Vol. 16, No. 4, 01.07.2010, p. 629-640.

Research output: Contribution to journalArticle

Rosenstock, Julio ; Fonseca, Vivian A. ; Garvey, W. Timothy ; Goldberg, Ronald B ; Handelsman, Yehuda ; Abby, Stacey L. ; Lai, Yu Ling ; Jin, Xiaoping ; Misir, Soamnauth ; Nagendran, Sukumar ; Jones, Michael R. / Initial combination therapy with metformin and colesevelam for achievement of glycemic and lipid goals in early type 2 diabetes. In: Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists. 2010 ; Vol. 16, No. 4. pp. 629-640.
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abstract = "To evaluate the efficacy and safety of initial combination therapy with metformin plus colesevelam in patients with early type 2 diabetes. In this 16-week, randomized, double-blind, placebo-controlled study, adults with type 2 diabetes (hemoglobin A1c [A1C] values of 6.5{\%} to 10.0{\%}) and hypercholesterolemia (low-density lipoprotein cholesterol [LDL-C] levels > or =100 mg/dL) were randomly assigned (1:1) to colesevelam (3.75 g/d) or placebo in combination with open-label metformin (850 mg/d; uptitrated at week 2 to 1,700 mg/d). The primary efficacy evaluation was change in A1C from baseline to study end (week 16 with last observation carried forward). In total, 286 patients were randomized: metformin/colesevelam (n = 145) or metformin/placebo (n = 141). Mean A1C was reduced by 1.1{\%} with metformin/colesevelam (from 7.8{\%} at baseline to 6.6{\%} at study end) and by 0.8{\%} with metformin/placebo (from 7.5{\%} to 6.7{\%}), resulting in a treatment difference of -0.3{\%} at study end (P = .0035). In addition, metformin/colesevelam significantly reduced LDL-C (-16.3{\%}), total cholesterol (-6.1{\%}), non-high-density lipoprotein cholesterol (-8.3{\%}), apolipoprotein B (-8.0{\%}), and high-sensitivity C-reactive protein (-17{\%}) and increased apolipoprotein A-I (+4.4{\%}) and triglycerides (+18.6{\%}) versus metformin/placebo (P<.01 for all). The proportions of patients who achieved recommended goals with metformin/colesevelam versus metformin/placebo, respectively, were as follows: A1C <7.0{\%} (67{\%} versus 56{\%} [P = .0092]), LDL-C <100 mg/dL (48{\%} versus 18{\%} [P<.0001]), and composite A1C <7.0{\%} + LDL-C <100 mg/dL (40{\%} versus 12{\%} [P<.0001]). Safety and tolerability were similar between the treatment groups. Metformin plus colesevelam may be a valid option for initial therapy to achieve glycemic and lipid goals safely in early type 2 diabetes.",
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AU - Fonseca, Vivian A.

AU - Garvey, W. Timothy

AU - Goldberg, Ronald B

AU - Handelsman, Yehuda

AU - Abby, Stacey L.

AU - Lai, Yu Ling

AU - Jin, Xiaoping

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AU - Jones, Michael R.

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N2 - To evaluate the efficacy and safety of initial combination therapy with metformin plus colesevelam in patients with early type 2 diabetes. In this 16-week, randomized, double-blind, placebo-controlled study, adults with type 2 diabetes (hemoglobin A1c [A1C] values of 6.5% to 10.0%) and hypercholesterolemia (low-density lipoprotein cholesterol [LDL-C] levels > or =100 mg/dL) were randomly assigned (1:1) to colesevelam (3.75 g/d) or placebo in combination with open-label metformin (850 mg/d; uptitrated at week 2 to 1,700 mg/d). The primary efficacy evaluation was change in A1C from baseline to study end (week 16 with last observation carried forward). In total, 286 patients were randomized: metformin/colesevelam (n = 145) or metformin/placebo (n = 141). Mean A1C was reduced by 1.1% with metformin/colesevelam (from 7.8% at baseline to 6.6% at study end) and by 0.8% with metformin/placebo (from 7.5% to 6.7%), resulting in a treatment difference of -0.3% at study end (P = .0035). In addition, metformin/colesevelam significantly reduced LDL-C (-16.3%), total cholesterol (-6.1%), non-high-density lipoprotein cholesterol (-8.3%), apolipoprotein B (-8.0%), and high-sensitivity C-reactive protein (-17%) and increased apolipoprotein A-I (+4.4%) and triglycerides (+18.6%) versus metformin/placebo (P<.01 for all). The proportions of patients who achieved recommended goals with metformin/colesevelam versus metformin/placebo, respectively, were as follows: A1C <7.0% (67% versus 56% [P = .0092]), LDL-C <100 mg/dL (48% versus 18% [P<.0001]), and composite A1C <7.0% + LDL-C <100 mg/dL (40% versus 12% [P<.0001]). Safety and tolerability were similar between the treatment groups. Metformin plus colesevelam may be a valid option for initial therapy to achieve glycemic and lipid goals safely in early type 2 diabetes.

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