Factors predicting therapeutic efficacy of combination treatment with sitagliptin and metformin in type 2 diabetic patients: The COSMETIC study

Soo Lim, Jee Hyun An, Hayley Shin, Ah Reum Khang, Yenna Lee, Hwa Young Ahn, Ji Won Yoon, Seon Mee Kang, Sung Hee Choi, Young Min Cho, Kyong Soo Park, Hak Chul Jang

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Abstract

Objective We assessed the predictive parameters for therapeutic efficacy of initial combination therapy with sitagliptin and metformin in drug-naïve type 2 diabetic patients. Design, Patients, and Measurements In this 52-week treatment study, 150 patients (mean age, 54.9 ± 12.5 years) with type 2 diabetes and HbA1c of 7.0-10% were treated with sitagliptin 100 mg once and metformin 500 mg twice daily. To assess the predictive parameters for therapeutic efficacy, a multivariate regression analysis was performed with baseline fasting glucose, insulin, C-peptide, and glucagon levels, homoeostasis model assessment-insulin resistance (HOMA-IR) and β-cell function (HOMA-B), insulinogenic index (IGI, defined as 30-0 min insulin/30-0 min glucose), and area under the curve for glucose, insulin, and C-peptide obtained after 75-g oral glucose tolerance test. Results After 52 weeks, mean HbA1c levels and fasting and postload 2-h glucose were significantly decreased from 8.7 ± 1.4% to 7.2 ± 1.3%, 9.2 ± 3.0 to 7.2 ± 1.8 mm, and 17.5 ± 5.1 to 10.9 ± 3.6 mm, respectively (P < 0.01). HOMA-B and IGI increased significantly from 50.3 ± 33.5 to 75.1 ± 32.8 and from 11.3 ± 1.3 to 35.0 ± 6.3 at 52 weeks, respectively (P < 0.01). Multivariate regression analysis indicated that the reduction in HbA1c was significantly associated with high baseline HbA1c, low IGI, and short duration of diabetes after adjusting for age, sex, body mass index, blood pressure, triglycerides, creatinine, high-sensitivity CRP, glucagon, C-peptide, HOMA-B, and HOMA-IR. No severe adverse events were observed. Conclusion These results suggest that drug-naïve type 2 diabetic patients with low β-cell function would benefit the most from early initial combination therapy of sitagliptin and metformin.

Original languageEnglish
Pages (from-to)215-223
Number of pages9
JournalClinical Endocrinology
Volume77
Issue number2
DOIs
StatePublished - 1 Aug 2012

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Metformin
C-Peptide
Glucose
Insulin
Glucagon
Insulin Resistance
Fasting
Homeostasis
Multivariate Analysis
Regression Analysis
Therapeutics
Glucose Tolerance Test
Pharmaceutical Preparations
Type 2 Diabetes Mellitus
Area Under Curve
Creatinine
Triglycerides
Body Mass Index
Sitagliptin Phosphate
Blood Pressure

Cite this

@article{9a10452097eb4c5b90e13c90bb4e73b0,
title = "Factors predicting therapeutic efficacy of combination treatment with sitagliptin and metformin in type 2 diabetic patients: The COSMETIC study",
abstract = "Objective We assessed the predictive parameters for therapeutic efficacy of initial combination therapy with sitagliptin and metformin in drug-na{\"i}ve type 2 diabetic patients. Design, Patients, and Measurements In this 52-week treatment study, 150 patients (mean age, 54.9 ± 12.5 years) with type 2 diabetes and HbA1c of 7.0-10{\%} were treated with sitagliptin 100 mg once and metformin 500 mg twice daily. To assess the predictive parameters for therapeutic efficacy, a multivariate regression analysis was performed with baseline fasting glucose, insulin, C-peptide, and glucagon levels, homoeostasis model assessment-insulin resistance (HOMA-IR) and β-cell function (HOMA-B), insulinogenic index (IGI, defined as 30-0 min insulin/30-0 min glucose), and area under the curve for glucose, insulin, and C-peptide obtained after 75-g oral glucose tolerance test. Results After 52 weeks, mean HbA1c levels and fasting and postload 2-h glucose were significantly decreased from 8.7 ± 1.4{\%} to 7.2 ± 1.3{\%}, 9.2 ± 3.0 to 7.2 ± 1.8 mm, and 17.5 ± 5.1 to 10.9 ± 3.6 mm, respectively (P < 0.01). HOMA-B and IGI increased significantly from 50.3 ± 33.5 to 75.1 ± 32.8 and from 11.3 ± 1.3 to 35.0 ± 6.3 at 52 weeks, respectively (P < 0.01). Multivariate regression analysis indicated that the reduction in HbA1c was significantly associated with high baseline HbA1c, low IGI, and short duration of diabetes after adjusting for age, sex, body mass index, blood pressure, triglycerides, creatinine, high-sensitivity CRP, glucagon, C-peptide, HOMA-B, and HOMA-IR. No severe adverse events were observed. Conclusion These results suggest that drug-na{\"i}ve type 2 diabetic patients with low β-cell function would benefit the most from early initial combination therapy of sitagliptin and metformin.",
author = "Soo Lim and An, {Jee Hyun} and Hayley Shin and Khang, {Ah Reum} and Yenna Lee and Ahn, {Hwa Young} and Yoon, {Ji Won} and Kang, {Seon Mee} and Choi, {Sung Hee} and Cho, {Young Min} and Park, {Kyong Soo} and Jang, {Hak Chul}",
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language = "English",
volume = "77",
pages = "215--223",
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Factors predicting therapeutic efficacy of combination treatment with sitagliptin and metformin in type 2 diabetic patients : The COSMETIC study. / Lim, Soo; An, Jee Hyun; Shin, Hayley; Khang, Ah Reum; Lee, Yenna; Ahn, Hwa Young; Yoon, Ji Won; Kang, Seon Mee; Choi, Sung Hee; Cho, Young Min; Park, Kyong Soo; Jang, Hak Chul.

In: Clinical Endocrinology, Vol. 77, No. 2, 01.08.2012, p. 215-223.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Factors predicting therapeutic efficacy of combination treatment with sitagliptin and metformin in type 2 diabetic patients

T2 - The COSMETIC study

AU - Lim, Soo

AU - An, Jee Hyun

AU - Shin, Hayley

AU - Khang, Ah Reum

AU - Lee, Yenna

AU - Ahn, Hwa Young

AU - Yoon, Ji Won

AU - Kang, Seon Mee

AU - Choi, Sung Hee

AU - Cho, Young Min

AU - Park, Kyong Soo

AU - Jang, Hak Chul

PY - 2012/8/1

Y1 - 2012/8/1

N2 - Objective We assessed the predictive parameters for therapeutic efficacy of initial combination therapy with sitagliptin and metformin in drug-naïve type 2 diabetic patients. Design, Patients, and Measurements In this 52-week treatment study, 150 patients (mean age, 54.9 ± 12.5 years) with type 2 diabetes and HbA1c of 7.0-10% were treated with sitagliptin 100 mg once and metformin 500 mg twice daily. To assess the predictive parameters for therapeutic efficacy, a multivariate regression analysis was performed with baseline fasting glucose, insulin, C-peptide, and glucagon levels, homoeostasis model assessment-insulin resistance (HOMA-IR) and β-cell function (HOMA-B), insulinogenic index (IGI, defined as 30-0 min insulin/30-0 min glucose), and area under the curve for glucose, insulin, and C-peptide obtained after 75-g oral glucose tolerance test. Results After 52 weeks, mean HbA1c levels and fasting and postload 2-h glucose were significantly decreased from 8.7 ± 1.4% to 7.2 ± 1.3%, 9.2 ± 3.0 to 7.2 ± 1.8 mm, and 17.5 ± 5.1 to 10.9 ± 3.6 mm, respectively (P < 0.01). HOMA-B and IGI increased significantly from 50.3 ± 33.5 to 75.1 ± 32.8 and from 11.3 ± 1.3 to 35.0 ± 6.3 at 52 weeks, respectively (P < 0.01). Multivariate regression analysis indicated that the reduction in HbA1c was significantly associated with high baseline HbA1c, low IGI, and short duration of diabetes after adjusting for age, sex, body mass index, blood pressure, triglycerides, creatinine, high-sensitivity CRP, glucagon, C-peptide, HOMA-B, and HOMA-IR. No severe adverse events were observed. Conclusion These results suggest that drug-naïve type 2 diabetic patients with low β-cell function would benefit the most from early initial combination therapy of sitagliptin and metformin.

AB - Objective We assessed the predictive parameters for therapeutic efficacy of initial combination therapy with sitagliptin and metformin in drug-naïve type 2 diabetic patients. Design, Patients, and Measurements In this 52-week treatment study, 150 patients (mean age, 54.9 ± 12.5 years) with type 2 diabetes and HbA1c of 7.0-10% were treated with sitagliptin 100 mg once and metformin 500 mg twice daily. To assess the predictive parameters for therapeutic efficacy, a multivariate regression analysis was performed with baseline fasting glucose, insulin, C-peptide, and glucagon levels, homoeostasis model assessment-insulin resistance (HOMA-IR) and β-cell function (HOMA-B), insulinogenic index (IGI, defined as 30-0 min insulin/30-0 min glucose), and area under the curve for glucose, insulin, and C-peptide obtained after 75-g oral glucose tolerance test. Results After 52 weeks, mean HbA1c levels and fasting and postload 2-h glucose were significantly decreased from 8.7 ± 1.4% to 7.2 ± 1.3%, 9.2 ± 3.0 to 7.2 ± 1.8 mm, and 17.5 ± 5.1 to 10.9 ± 3.6 mm, respectively (P < 0.01). HOMA-B and IGI increased significantly from 50.3 ± 33.5 to 75.1 ± 32.8 and from 11.3 ± 1.3 to 35.0 ± 6.3 at 52 weeks, respectively (P < 0.01). Multivariate regression analysis indicated that the reduction in HbA1c was significantly associated with high baseline HbA1c, low IGI, and short duration of diabetes after adjusting for age, sex, body mass index, blood pressure, triglycerides, creatinine, high-sensitivity CRP, glucagon, C-peptide, HOMA-B, and HOMA-IR. No severe adverse events were observed. Conclusion These results suggest that drug-naïve type 2 diabetic patients with low β-cell function would benefit the most from early initial combination therapy of sitagliptin and metformin.

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U2 - 10.1111/j.1365-2265.2011.04240.x

DO - 10.1111/j.1365-2265.2011.04240.x

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SN - 0300-0664

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