Treatment of Type 2 Diabetes with a Breakable Extended Release Gliclazide Formulation in Primary Care: The Xrise Study.
OBJECTIVE
This study examines whether a new, scored and breakable once daily gliclazide tablet formulation, gliclazide XR 60 mg, that enables a simple 2-steps titration, can improve glycemic control rates in the community.


METHODS
In a prospective multicenter study of 4 months duration, organised in the primary care setting of urban India, type 2 diabetes patients, uncontrolled with diet alone or metformin monotherapy, received 1 (60 mg), 1½ (90 mg), or 2 (120 mg) tablets of gliclazide XR 60 mg to achieve a target fasting plasma glucose of 126 mg/dl, or HbA1c of 7%. The primary outcome was the frequency of patients achieving glycemic control.


RESULTS
Two hundred eleven investigators recruited 679 patients distributed throughout India. On intention to treat analysis, the number (%, 95% confidence interval, CI) of patients achieving glycemic control was, 526 (81.9, 78.8 to 84.6); with gliclazide XR 60 mg 1 tablet, 285 (42.0, 38.3 to 45.7); 1½ tablets, 143 (21.1, 18.2 to 24.3); and 2 tablets, 98 (14.4, 12.0 to 17.3). Hypoglycaemic episodes were reported by 27 (4.0, 2.8 to 5.7) patients. Mean (95% CI) FPG decreased by 78.3 (73.9 to 82.7, P < 0.01) mg/dl; with 1 tablet gliclazide XR 60 mg, by 66.0 (61.1 to 70.9, P < 0.01) mg/dl; 1-½ tablets, by 80.1 (71.2 to 88.5, P < 0.01) mg/dl; and 2 tablets, by 106.5 (93.4 to 119.5, P< 0.01) mg/dl. HbA1c decreased by 1.5 (1.3 to 1.5, P < 0.01).


CONCLUSIONS
In primary care, once daily, breakable extended release gliclazide XR 60 mg, with a simple two step titration to administer maximum recommended dosage is effective in achieving short term glycemic control with a low frequency of hypoglycaemia, in monotherapy or in combination with metformin.
Dr. Mohan's Diabetes Specialities Centre and Madras Diabetes Research Foundation, Chennai, Tamil Nadu.
V
V
Mohan
Hashu Advani Medical Centre, Mumbai, Maharashtra.
V
V
Chopra
KPC Medical College, Kolkata, West Bengal.
D
D
Sanyal
Diabetes, Thyroid and Women Health Clinic, Ghaziabad, Uttar Pradesh.
S
S
Jain
123 Diabetes Hospital, Hyderabad, Telangana.
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J
Jayaprakashsai
D000328:Adult; D001786:Blood Glucose / Q000378:metabolism; D003692:Delayed-Action Preparations; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000378:metabolism; D004359:Drug Therapy, Combination; D005260:Female; D005907:Gliclazide / Q000627:therapeutic use*; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007194:India; D008297:Male; D008687:Metformin / Q000627:therapeutic use; D008875:Middle Aged; D011320:Primary Health Care; D011446:Prospective Studies; D013607:Tablets; D016896:Treatment Outcome
D001786:Blood Glucose; D003692:Delayed-Action Preparations; D005907:Gliclazide; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D013607:Tablets; C517652:hemoglobin A1c protein, human