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Clinical Pharmacology
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Compared with placebo, improvement in glycemic control was seen at all dose levels of GLUCOPHAGE XR (metformin hydrochloride extended-release tablets) and treatment was not associated with any significant change in weight (see DOSAGE AND ADMINISTRATION for dosing recommendations for GLUCOPHAGE and GLUCOPHAGE XR).
A 24-week, double-blind, randomized study of GLUCOPHAGE XR, taken once daily with the evening meal, and GLUCOPHAGE (metformin hydrochloride tablets), taken twice daily (with breakfast and evening meal), was conducted in patients with type 2 diabetes who had been treated with GLUCOPHAGE 500 mg twice daily for at least 8 weeks prior to study entry.
The GLUCOPHAGE dose had not necessarily been titrated to achieve a specific level of glycemic control prior to study entry. Patients qualified for the study if HbA1c was ≤ 8.5% and FPG was ≤ 200mg/dL. Changes in glycemic control and body weight are shown in Table 7.
Table 7: Summary of Mean Changes from Baseline* in HbA1c,
Fasting Plasma Glucose, and Body Weight at Week 12 and at Final Visit (24-week
study)
| GLUCOPHAGE 500 mg Twice Daily |
GLUCOPHAGE XR | ||
| 1000 mg Once Daily |
1500 mg Once Daily |
||
| Hemoglobin A1c (%) | (n=67) | (n=72) | (n=66) |
| Baseline | 7.06 | 6.99 | 7.02 |
| Change at 12 Weeks | 0.14 | 0.23 | 0.04 |
| (95% CI) | (-0.03, 0.31) | (0.10, 0.36) | (-0.08, 0.15) |
| Change at FINAL VISIT | 0.14a | 0.27 | 0.13 |
| (95% CI) | (-0.04, 0.31) | (0.11, 0.43) | (-0.02, 0.28) |
| FPG (mg/dL) | (n=69) | (n=72) | (n=70) |
| Baseline | 127.2 | 131.0 | 131.4 |
| Change at 12 Weeks | 12.9 | 9.5 | 3.7 |
| (95% CI) | (6.5, 19.4) | (4.4, 14.6) | (-0.4, 7.8) |
| Change at FINAL VISIT | 14.0 | 11.5 | 7.6 |
| (95% CI) | (7.0, 21.0) | (4.4, 18.6) | (1.0, 14.2) |
| Body Weight (lbs) | (n=71) | (n=74) | (n=71) |
| Baseline | 210.3 | 202.8 | 192.7 |
| Change at 12 Weeks | 0.4 | 0.9 | 0.7 |
| (95% CI) | (-0.4, 1.5) | (0.0, 2.0) | (-0.4, 1.8) |
| Change at FINAL VISIT | 0.9 | 1.1 | 0.9 |
| (95% CI) | (-0.4, 2.2) | (-0.2, 2.4) | (-0.4, 2.0) |
| * All patients on GLUCOPHAGE 500 mg twice
daily at Baseline a n=68 |
|||
Generic Name: Metformin Hcl
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