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Clinical Pharmacology
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Changes in lipid parameters in the previously described placebo-controlled dose-response study of GLUCOPHAGE XR are shown in Table 8.
Table 8: Summary of Mean Percent Changes from Baseline*
in Major
Lipid Variables at Final Visit (16-week study)
| GLUCOPHAGEXR | Placebo | |||||
| 500 mg Once Daily |
1000 mg Once Daily |
1500 mg Once Daily |
2000 mg Once Daily |
1000 mg Twice Daily |
||
| Total Cholesterol (mg/dL) | (n=120) | (n=113) | (n=110) | (n=126) | (n=117) | (n=110) |
| Baseline | 210.3 | 218.1 | 214.6 | 204.4 | 208.2 | 208.6 |
| Mean % Change at FINAL VISIT | 1.0% | 1.7% | 0.7% | -1.6% | -2.6% | 2.6% |
| Total Triglycerides (mg/dL) | (n=120) | (n=113) | (n=110) | (n=126) | (n=117) | (n=110) |
| Baseline | 220.2 | 211.9 | 198.0 | 194.2 | 179.0 | 211.7 |
| Mean % Change at FINAL VISIT | 14.5% | 9.4% | 15.1% | 14.9% | 9.4% | 10.9% |
| LDL-Cholesterol (mg/dL) | (n=119) | (n=113) | (n=109) | (n=126) | (n=117) | (n=107) |
| Baseline | 131.0 | 134.9 | 135.8 | 125.8 | 131.4 | 131.9 |
| Mean % Change at FINAL VISIT | -1.4% | -1.6% | -3.5% | -3.3% | -5.5% | 3.2% |
| HDL-Cholesterol (mg/dL) | (n=120) | (n=108) | (n=108) | (n=125) | (n=117) | (n=108) |
| Baseline | 40.8 | 41.6 | 40.6 | 40.2 | 42.4 | 39.4 |
| Mean % Change at FINAL VISIT | 6.2% | 8.6% | 5.5% | 6.1% | 7.1% | 5.8% |
| *All patients on diet therapy at Baseline | ||||||
Changes in lipid parameters in the previously described study of GLUCOPHAGE and GLUCOPHAGE XR are shown in Table 9.
Table 9: Summary of Mean Percent Changes from Baseline*
in Major
Lipid Variables at Final Visit (24-week study)
| GLUCOPHAGE 500 mg Twice Daily |
GLUCOPHAGE XR | ||
| 1000 mg Once Daily |
1500 mg Once Daily |
||
| Total Cholesterol (mg/dL) | (n=68) | (n=70) | (n=66) |
| Baseline | 199.0 | 201.9 | 201.6 |
| Mean % Change at FINAL VISIT | 0.1% | 1.3% | 0.1% |
| Total Triglycerides (mg/dL) | (n=68) | (n=70) | (n=66) |
| Baseline | 178.0 | 169.2 | 206.8 |
| Mean % Change at FINAL VISIT | 6.3% | 25.3% | 33.4% |
| LDL-Cholesterol (mg/dL) | (n=68) | (n=70) | (n=66) |
| Baseline | 122.1 | 126.2 | 115.7 |
| Mean % Change at FINAL VISIT | -1.3% | -3.3% | -3.7% |
| HDL-Cholesterol (mg/dL) | (n=68) | (n=70) | (n=65) |
| Baseline | 41.9 | 41.7 | 44.6 |
| Mean % Change at FINAL VISIT | 4.8% | 1.0% | -2.1% |
| *All patients on GLUCOPHAGE 500 mg twice daily at Baseline | |||
Pediatric Clinical Studies
In a double-blind, placebo-controlled study in pediatric patients aged 10 to 16 years with type 2 diabetes (mean FPG 182.2 mg/dL), treatment with GLUCOPHAGE (up to 2000 mg/day) for up to 16 weeks (mean duration of treatment 11 weeks) resulted in a significant mean net reduction in FPG of 64.3 mg/dL, compared with placebo (see Table 10).
Table 10: GLUCOPHAGE vs Placebo (Pediatricsa)
Summary of Mean
Changes from Baseline* in Plasma Glucose and Body Weight
at Final Visit
| GLUCOPHAGE | Placebo | p-Value | |
| FPG (mg/dL) | (n=37) | (n=36) | |
| Baseline | 162.4 | 192.3 | |
| Change at FINAL VISIT | -42.9 | 21.4 | <0.001 |
| Body Weight (lbs) | (n=39) | (n=38) | |
| Baseline | 205.3 | 189.0 | |
| Change at FINAL VISIT | -3.3 | -2.0 | NS** |
|
a Pediatric patients mean age 13.8 years (range 10-16 years)
* All patients on diet therapy at Baseline ** Not statistically significant |
|||
Generic Name: Metformin Hcl
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