title: Comparison between the therapeutic effect of metformin, glimepiride and their combination as an add-on treatment to insulin glargine in uncontrolled patients with type 2 diabetes.
abstract: OBJECTIVE
  To compare the commonly prescribed oral anti-diabetic drug (OAD) combinations to use as an add-on therapy with insulin glargine in patients with uncontrolled type 2 diabetes despite submaximal doses of OADs.
  
  
  METHODS
  People with inadequately controlled type 2 diabetes (n = 99) were randomly assigned on a 1∶1∶1 basis to receive insulin glargin, with fixed doses of glimepiride, metformin, and glimepiride plus metformin. Outcomes assessed included HbA1c, the changes in fasting glucose levels, body weight, serum lipids values, insulin dose and symptomatic hypoglycemia.
  
  
  RESULTS
  After 24 weeks, HbA1C levels improved from (mean ± SD) 8.5±0.9% to 7.7±0.8% (69.0±10.0 mmol/mol to 60.8±8.6 mmol/mol) with insulin glargine plus metformin, from 8.4±1.0% to 7.7±1.3% (68.8±10.6 mmol/mol to 61.1±14.4 mmol/mol) with insulin glargine plus glimepiride and from 8.7±0.9% to 7.3±0.6% (71.7±9.8 mmol/mol to 56.2±6.7 mmol/mol) with insulin glargine plus glimepirde plus metformin. The decrease in HbA1c was more pronounced with insulin glargine plus glimepiride plus metformin than with insulin glargine plus metformin (0.49% [CI, 0.16% to 0.82%]; P = 0.005) (5.10 mmol/mol [CI, 1.64 to 8.61]; P = 0.005) and insulin glargine plus glimepiride (0.59% [CI, 0.13% to 1.05%]; P = 0.012) (5.87 mmol/mol [CI, 1.10 to 10.64]; P = 0.012) (overall P = 0.02). Weight gain and the risk of hypoglycemia of any type did not significantly differ among the treatment groups.
  
  
  CONCLUSIONS
  The combination therapy of metformin and glimepiride plus glargine insulin resulted in a significant improvement in overall glycemic control as compared with the other combinations.
  ClinicalTrials.gov, NCT00708578. The approval number of Kangbuk Samsung hospital's institutional review board (IRB): C0825.
authors.affiliation: Department of Endocrinology and Metabolism, Sungkyunkwan University School of Medicine, Kangbuk Samsung Hospital, Jongro, South Korea.
authors.forename: Cheol-Young
authors.initials: CY
authors.lastname: Park
authors.affiliation: Department of Endocrinology and Metabolism, Hallym University School of Medicine, Hallym University Sacred Heart Hospital, GyeongGi, South Korea.
authors.forename: Jun Goo
authors.initials: JG
authors.lastname: Kang
authors.affiliation: Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Republic of Korea.
authors.forename: Suk
authors.initials: S
authors.lastname: Chon
authors.affiliation: Department of Endocrinology and Metabolism, Inje University, Ilsan Paik Hospital, Goyang, Republic of Korea.
authors.forename: Junghyun
authors.initials: J
authors.lastname: Noh
authors.affiliation: Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Republic of Korea.
authors.forename: Seung Joon
authors.initials: SJ
authors.lastname: Oh
authors.affiliation: Department of Endocrinology and Metabolism, Hanyang University School of Medicine, Seoul, Korea.
authors.forename: Chang Beom
authors.initials: CB
authors.lastname: Lee
authors.affiliation: Department of Endocrinology and Metabolism, Sungkyunkwan University School of Medicine, Kangbuk Samsung Hospital, Jongro, South Korea.
authors.forename: Sung Woo
authors.initials: SW
authors.lastname: Park
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005215:Fasting / Q000097:blood; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D000069036:Insulin Glargine / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D013453:Sulfonylurea Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D000069036:Insulin Glargine; D008687:Metformin; D013453:Sulfonylurea Compounds; C057619:glimepiride