Avandia Clinical Trials and Studies
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Avandia Clinical Trials and Studies
A total of 2315 patients with type 2 diabetes, previously treated with diet alone or antidiabetic medication(s), were treated with Avandia as monotherapy in six double-blind studies, which included two 26-week placebo-controlled studies, one 52-week glyburide-controlled study, and three placebo-controlled doseranging studies of 8 to 12 weeks duration. Previous antidiabetic medication(s) were withdrawn and patients entered a 2 to 4 week placebo run-in period prior to randomization.
Two 26-week, double-blind, placebo-controlled trials, in patients with type 2 238 diabetes with inadequate glycemic control (mean baseline FPG approximately 228 mg/dL and mean baseline HbA1c 8.9%), were conducted. Treatment with Avandia produced statistically significant improvements in FPG and HbA1c compared to baseline and relative to placebo.
When administered at the same total daily dose, Avandia was generally more effective in reducing FPG and HbA1c when administered in divided doses twice daily compared to once daily doses. However, for HbA1c, the difference between the 4 mg once daily and 2 mg twice daily doses was not statistically significant.
Long-term maintenance of effect was evaluated in a 52-week, double-blind, glyburide-controlled trial in patients with type 2 diabetes. Patients were randomized to treatment with Avandia 2 mg twice daily (N= 195) or Avandia 4 mg twice daily (N= 189) or glyburide (N= 202) for 52 weeks. Patients receiving glyburide were given an initial dosage of either 2.5 mg/day or 5.0 mg/day. The dosage was then titrated in 2.5 mg/day increments over the next 12 weeks, to a maximum dosage of 15.0 mg/day in order to optimize glycemic control. Thereafter the glyburide dose was kept constant.
The median titrated dose of glyburide was 7.5 mg. All treatments resulted in a statistically significant improvement in glycemic control from baseline. At the end of week 52, the reduction from baseline in FPG and HbA1c was -40.8 mg/dL and -0.53% with Avandia 4 mg twice daily; -25.4 mg/dL and - 264 0.27% with Avandia 2 mg twice daily; and -30.0 mg/dL and -0.72% with glyburide. For HbA1c, the difference between Avandia 4 mg twice daily and glyburide was not statistically significant at week 52. The initial fall in FPG with glyburide was greater than with Avandia; however, this effect was less durable over time. The improvement in glycemic control seen with Avandia 4 mg twice daily at week 26 was maintained through week 52 of the study.
Hypoglycemia was reported in 12.1% of glyburide-treated patients versus 0.5% (2 mg twice daily) and 1.6% (4 mg twice daily) of patients treated with Avandia. The improvements in glycemic control were associated with a mean weight gain of 1.75 kg and 2.95 kg for patients treated with 2 mg and 4 mg twice daily of Avandia, respectively versus 1.9 kg in glyburide-treated patients. In patients treated with Avandia, C-peptide, insulin, pro-insulin, and pro-insulin split products were significantly reduced in a dose-ordered fashion, compared to an increase in the glyburide-treated patients.
Combination with Metformin:
A total of 670 patients with type 2 diabetes participated in two 26-week, randomized, double-blind, placebo/active-controlled studies designed to assess the efficacy of Avandia in combination with metformin. Avandia, administered in either once daily or twice daily dosing regimens, was added to the therapy of patients who were inadequately controlled on a maximum dose (2.5 grams/day) of metformin.
In one study, patients inadequately controlled on 2.5 grams/day of metformin (mean baseline FPG 216 mg/dL and mean baseline HbA1c 8.8%) were randomized to receive Avandia 4 mg once daily, Avandia 8 mg once daily, or placebo in addition to metformin. A statistically significant improvement in FPG and HbA1c was observed in patients treated with the combinations of metformin and Avandia 4 mg once daily and Avandia 8 mg once daily, versus patients continued on metformin alone
In a second 26-week study, patients with type 2 diabetes inadequately controlled on 2.5 grams/day of metformin who were randomized to receive the combination of Avandia 4 mg twice daily and metformin (N= 105) showed a statistically significant improvement in glycemic control with a mean treatment effect for FPG of -56 mg/dL and a mean treatment effect for HbA1c of -0.8% over metformin alone. The combination of metformin and Avandia resulted in lower levels of FPG and HbA1c than either agent alone.
Patients who were inadequately controlled on a maximum dose (2.5 grams/day) of metformin and who were switched to monotherapy with Avandia demonstrated loss of glycemic control, as evidenced by increases in FPG and HbA1c. In this group, increases in LDL and VLDL were also seen.
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