nd). The greater efficacy response of the combination group was achieved at a lower daily repaglinide dosage than in the PRANDIN monotherapy group. Mean weight increases associated with combination, PRANDIN and pioglitazone therapy were 5.5 kg, 0.3 kg, and 2.0 kg respectively.
HbA1c Values from PRANDIN / Pioglitazone Combination Study
Subjects with FPG above 270 mg/dL were withdrawn from the study.
A combination therapy regimen of PRANDIN and rosiglitazone was compared to monotherapy with either agent alone in a 24-week trial that enrolled 252 patients previously treated with sulfonylurea or metformin (HbA1c > 7.0%). Combination therapy resulted in significantly greater improvement in glycemic control as compared to monotherapy (table below). The glycemic effects of the combination therapy were dose-sparing with respect to both total daily PRANDIN dosage and total daily rosiglitazone dosage (see table legend). A greater efficacy response of the combination therapy group was achieved with half the median daily dose of PRANDIN and rosiglitazone, as compared to the respective monotherapy groups. Mean weight change associated with combination therapy was greater than that of PRANDIN monotherapy.
Mean Changes from Baseline in Glycemic Parameters and Weight in a 24-Week PRANDIN/Rosiglitazone Combination Study*
*based on intent-to-treat analysisp-value0.001 for comparison to either monotherapyp-value < 0.001 for comparison to PRANDINPRANDINCombinationRosiglitazoneN6312762HbA1c (%)Baseline9.39.19.0Change by 24 weeks-0.17-1.43-0.56FPG (mg/dL)Baseline269257252Change by 24 weeks-54-94-67Change in Weight (kg)+1.3+4.5+3.3
INDICATIONS & USAGE
PRANDIN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
CONTRAINDICATIONS
PRANDIN is contraindicated in patients with:
1. Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.
2. Type 1 diabetes.
3. Co-administration of gemfibrozil.
4. Known hypersensitivity to the drug or its inactive ingredients.
PRECAUTIONS
General:
PRANDIN is not indicated for use in combination with NPH-insulin (See ADVERSE REACTIONS,Cardiovascular Events).
Macrovascular Outcomes:
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with PRANDIN or any other anti-diabetic drug.
Hypoglycemia:All oral blood glucose-lowering drugs including repaglinide are capable of producing hypoglycemia. Proper patient selection, dosage, and instructions to the patients are important to avoid hypoglycemic episodes. Hepatic insufficiency may cause elevated repaglinide blood levels and may diminish gluconeogenic capacity, both of which increase the risk of serious hypoglycemia. Elderly, debilitated, or malnourished patients, and those with adrenal, pituitary, hepatic, or severe renal insufficiency may be particularly susceptible to the hypoglycemic action of glucose-lowering drugs.
Hypoglycemia may be difficult to recognize in the elderly and in people taking beta-adrenergic blocking drugs. Hypoglycemia is more likely to occur when caloric intake is deficient, after severe or prolonged exercise, when alcohol is ingested, or when more than one glucose-lowering drug is used.
The frequency of hypoglycemia is greater in patients with type 2 diabetes who have not been previously treated with oral blo |
