Four-year durability of initial combination therapy with sitagliptin and metformin in patients with type 2 diabetes in clinical practice; COSMIC study

Eu Jeong Ku, Kyong Yeon Jung, Yoon Ji Kim, Kyoung Min Kim, Jae Hoon Moon, Sung Hee Choi, Young Min Cho, Kyong Soo Park, Hak Chul Jang, Soo Lim, Bo Ahrén

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Abstract

Objectives: We investigated the efficacy of initial combination therapy with sitagliptin and metformin in patients with type 2 diabetes for 4 years in clinical practice. Methods: Between 2009 and 2010, we reviewed 1,178 patients with type 2 diabetes (HbA1c≥7.5% or 58 mmol/mol) prescribed initial combination therapy with sitagliptin and metformin. After excluding 288 patients without a second follow-up, 890 individuals (age, 58.0 ± 12.5 years; BMI, 25.4 ± 3.5 kg/m2; HbA1c, 8.6 ± 1.1%) were followed up with every 3-6 months for 4 years. Homeostasis model assessments for insulin resistance and β-cell function (HOMA-β) were recorded at baseline. The response criterion was HbA1c reduction by ≥0.8% from baseline or attainment of the target HbA1c (≤7.0% or 53 mmol/mol). At the end of every year of treatment, changes in HbA1c from the baseline were assessed. Results: After 1 year, 72.2% of patients with initial combination therapy had responded, defined as HbA1c reduction ≥0.8% or attainment of the target HbA1c≤7.0%. After 4 years, 35.4% of the patients still showed a response, with an HbA1c level of 7.0 ± 0.9%. A high HbA1c level at baseline was the most significant independent predictor of the long-term response (P<0.001). In addition, low HOMA-β was a significant predictor of a greater reduction in HbA1c. This treatment was generally well tolerated over the 4-year follow-up period, without any serious adverse events. Conclusions: This real-world follow-up study shows a persistent glucose-reducing effect of initial combination therapy with sitagliptin and metformin for up to 4 years.

Original languageEnglish
Article numbere0129477
JournalPLoS ONE
Volume10
Issue number6
DOIs
StatePublished - 12 Jun 2015

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