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Glucophage
Clinical Pharmacology
Glucophage
A second double-blind, placebo-controlled study (n=51), with 16 weeks of randomized treatment, demonstrated that in patients with type 2 diabetes controlled on insulin for 8 weeks with an average HbA1c of 7.46 ± 0.97%, the addition of GLUCOPHAGE maintained similar glycemic control (HbA1c 7.15 0.61 versus 6.97 ± 0.62 for GLUCOPHAGE plus insulin and placebo plus insulin, respectively) with 19% less insulin versus baseline (reduction of 23.68 ± 30.22 versus an increase of 0.43 25.20 units for GLUCOPHAGE plus insulin and placebo plus insulin, p<0.01). In addition, this study demonstrated that the combination of GLUCOPHAGE plus insulin resulted in reduction in body weight of 3.11 ± 4.30 lbs, compared to an increase of 1.30 ± 6.08 lbs for placebo plus insulin, p=0.01.
Glucophage Xr
A 24-week, double-blind, placebo-controlled study of GLUCOPHAGE XR, taken once daily with the evening meal, was conducted in patients with type 2 diabetes who had failed to achieve glycemic control with diet and exercise (HbA1c 7.0-10.0%, FPG 126-270 mg/dL). Patients entering the study had a mean baseline HbA1c of 8.0% and a mean baseline FPG of 176 mg/dL. After 12 weeks treatment, mean HbA1c had increased from baseline by 0.1% and mean FPG decreased from baseline by 2 mg/dL in the placebo group, compared with a decrease in mean HbA1c of 0.6% and a decrease in mean FPG of 23 mg/dL in patients treated with GLUCOPHAGE XR 1000 mg once daily. Subsequently, the treatment dose was increased to 1500 mg once daily if HbA1c was ≥ 7.0% but <8.0% (patients with HbA1c ≥ 8.0% were discontinued from the study). At the final visit (24-week), mean HbA1c had increased 0.2% from baseline in placebo patients and decreased 0.6% with GLUCOPHAGE XR.
A 16-week, double-blind, placebo-controlled, dose-response study of GLUCOPHAGE XR, taken once daily with the evening meal or twice daily with meals, was conducted in patients with type 2 diabetes who had failed to achieve glycemic control with diet and exercise (HbA1c 7.0-11.0%, FPG 126-280 mg/dL). Changes in glycemic control and body weight are shown in Table 6.
Table 6: Summary of Mean Changes from Baseline* in HbA1c,
Fasting
Plasma Glucose, and Body Weight 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 |
||
| Hemoglobin A1c (%) | (n=115) | (n=115) | (n=111) | (n=125) | (n=112) | (n=111) |
| Baseline | 8.2 | 8.4 | 8.3 | 8.4 | 8.4 | 8.4 |
| Change at FINAL VISIT | -0.4 | -0.6 | -0.9 | -0.8 | -1.1 | 0.1 |
| p-valuea | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | - |
| FPG (mg/dL) | (n=126) | (n=118) | (n=120) | (n=132) | (n=122) | (n=113) |
| Baseline | 182.7 | 183.7 | 178.9 | 181.0 | 181.6 | 179.6 |
| Change at FINAL VISIT | -15.2 | -19.3 | -28.5 | -29.9 | -33.6 | 7.6 |
| p-valuea | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | - |
| Body Weight (lbs) | (n=125) | (n=119) | (n=117) | (n=131) | (n=119) | (n=113) |
| Baseline | 192.9 | 191.8 | 188.3 | 195.4 | 192.5 | 194.3 |
| Change at FINAL VISIT | -1.3 | -1.3 | -0.7 | -1.5 | -2.2 | -1.8 |
| p-valuea | NS** | NS** | NS** | NS** | NS** | - |
| *All patients on diet therapy at Baseline
a All comparisons versus Placebo ** Not statistically significant |
||||||
Generic Name: Metformin Hcl
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