Four-Year Durability of Initial Combination Therapy with Sitagliptin and Metformin in Patients with Type 2 Diabetes in Clinical Practice; COSMIC Study

• Published in: PloS one 2015-06, Vol.10 (6), p.e0129477
• Main Authors: Ku, Eu Jeong, Jung, Kyong Yeon, Kim, Yoon Ji, Kim, Kyoung Min, Moon, Jae Hoon, Choi, Sung Hee, Cho, Young Min, Park, Kyong Soo, Jang, Hak Chul, Lim, Soo, Ahrén, Bo
• Format: Article
• Language: English
• Subjects: Adult; Aged; Alcohol use; Annan klinisk medicin; Antidiabetics; Body mass; Care and treatment; Clinical Medicine; Combination therapy; Diabetes; Diabetes mellitus; Diabetes mellitus (non-insulin dependent); Diabetes Mellitus, Type 2 - drug therapy; Drug Therapy, Combination; Durability; Endocrinology and Diabetes; Endokrinologi och diabetes; FDA approval; Female; Glucose; Hemoglobin; Hemoglobin A - metabolism; Homeostasis; Humans; Hypoglycemic Agents - administration & dosage; Hypoglycemic Agents - adverse effects; Hypoglycemic Agents - therapeutic use; Insulin; Insulin resistance; Internal medicine; Klinisk medicin; Male; Medical and Health Sciences; Medical research; Medicin och hälsovetenskap; Medicine; Metformin; Metformin - administration & dosage; Metformin - adverse effects; Metformin - therapeutic use; Middle Aged; Other Clinical Medicine; Patients; Reduction; Review boards; Sitagliptin Phosphate - administration & dosage; Sitagliptin Phosphate - adverse effects; Sitagliptin Phosphate - therapeutic use; Studies; Systematic review; Therapy; Type 2 diabetes
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0129477

We investigated the efficacy of initial combination therapy with sitagliptin and metformin in patients with type 2 diabetes for 4 years in clinical practice. 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. 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