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Evaluation of Efficacy and Tolerability of Glimepiride and Metformin Combination: A Multicentric Study in Patients with Type-2 Diabetes Mellitus, Uncontrolled on Monotherapy with Sulfonylurea or Metformin.
MedLine Citation:
PMID:  21326082     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
The objectives of this study were to evaluate the efficacy and tolerability of glimepiride plus extended release metformin (MET) on glycemic control in patients with type-2 diabetes mellitus uncontrolled on monotherapy with sulfonylurea or MET. This was a prospective, open-labeled, multicentric study over 12 weeks. Patients who were diagnosed with type-2 diabetes and were uncontrolled on monotherapy with single oral hypoglycemic agents such as glimepiride or MET and characterized by glycosylated hemoglobin (HbA1c) ≥7% and ≤10% and fasting plasma glucose (FPG) ≥ 140 mg/dL were enrolled in this study. Treatment regimen was started at 1 mg of glimepiride plus 500 mg of MET once a day and was titrated to next dose level depending on the clinician's judgment, not exceeding a total daily dose of 8 mg of glimepiride and 2000 mg of MET. After 12-weektreatment, glimepiride plus MET combination showed improvement in metabolic control as assessed by changes in HbA1c, FPG, and post prandial glucose (PPG). Primary efficacy parameter, HbA1c, was significantly reduced to (7.65 ± 1.70) at the end of the treatment from the baseline value (8.35 ± 0.93) (P < 0.001). Of the patients, 65.79% showed ≥0.5% reduction in HbA1c and or HbA1c <7% at the end of the therapy. FPG and PPG were significantly reduced at the end of the therapy as compared with baseline values (P < 0.001). Moreover, the lipid profile was also improved during the treatment period. The addition of glimepiride to MET is an effective treatment for patients inadequately controlled on sulfonylurea or Met alone. A combination of glimepiride with MET achieves good glycemic control with better tolerability profile.
Authors:
Anil Pareek; Nitin B Chandurkar; Harsha R Salkar; Mangala S Borkar; Dharmendra Tiwari
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-2-15
Journal Detail:
Title:  American journal of therapeutics     Volume:  -     ISSN:  1536-3686     ISO Abbreviation:  -     Publication Date:  2011 Feb 
Date Detail:
Created Date:  2011-2-17     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9441347     Medline TA:  Am J Ther     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
1Medical Affairs and Clinical Research, Ipca Laboratories Limited, Kandivli (West), Mumbai, India; 2Clinical Research and Development, Ipca Laboratories Limited, Kandivli (West), Mumbai, India; 3Department of Medicine, Government Medical College and Hospital, Nagpur, India; 4Department of Medicine, Government Medical College and Hospital, Aurangabad, India; and 5Department of Medicine, GR Medical College and Hospital and J. A. Group of Hospitals, Gwalior, India.
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