Clinical Study: Alone
Evidence of PRANDIN® (repaglinide) Tablets when used alone in the treatment of type 2 diabetes
Study design and methods:
A 3-month, multicenter, randomized, double-blind, placebo-controlled, dose-titration study in patients with type 2 diabetes, with weekly increments of 0.25 mg, 0.5 mg, 1 mg, and 2 mg, up to a maximum dose of 4 mg pre ially or until FPG <160 mg/dL was achieved (PRANDIN®, n = 66; placebo, n = 33).1
Efficacy of monotherapy with PRANDIN®
PRANDIN® effectively lowered 3 major glycemic markers when used alone.1
- From baseline to last visit, a significant reduction in HbA1c of 1.7% was seen in patients treated with PRANDIN® versus placebo (p<0.0001)
- Mean FPG and PPG also decreased vs placebo (p<0.01)
Study Investigators conclude:
"In addition to overall improvement in glycemic control seen with [PRANDIN®] in both sulfonylurea-treated and OHA [oral hypoglycemic agent]-naOve patients, [PRANDIN®] had a potent glucose-lowering effect in the post ial period."1
In clinical trials, the most common adverse events leading to discontinuation of PRANDIN® therapy were hyperglycemia, hypoglycemia, and related symptoms. The most common other side effects were cold- and flu-like symptoms, headache, diarrhea, joint ache, and back pain.
Reference:
- Goldberg RB, Einhorn D, Lucas CP, et al. A randomized placebo-controlled trial of repaglinide in the treatment of type 2 diabetes. Diabetes Care. 1998;21:1897-1903.
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