PRANDIN SUMMARY
PRANDIN® (repaglinide) is an oral blood glucose-lowering drug of the meglitinide class used in the management of type 2 diabetes mellitus (also known as non-insulin dependent diabetes mellitus or NIDDM). Repaglinide, S(+) 2-ethoxy-4(2((3-methyl-1-(2-(1-piperidinyl) phenyl)-butyl)amino)-2-oxoethyl) benzoic acid, is chemically unrelated to the oral sulfonylurea insulin secretagogues.
PRANDIN is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with type 2 diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled satisfactorily by diet and exercise alone.
PRANDIN is also indicated for combination therapy use (with metformin or thiazolidinediones) to lower blood glucose in patients whose hyperglycemia cannot be controlled by diet and exercise plus monotherapy with any of the following agents: metformin, sulfonylureas, repaglinide, or thiazolidinediones. If glucose control has not been achieved after a suitable trial of combination therapy, consideration should be given to discontinuing these drugs and using insulin. Judgments should be based on regular clinical and laboratory evaluations.
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NEWS HIGHLIGHTS
Published Studies Related to Prandin (Repaglinide)
Randomized study of repaglinide alone and in combination with metformin in Chinese subjects with type 2 diabetes naive to oral antidiabetes therapy. [2011.12]
Objective: The aim of this research is to determine efficacy and safety of repaglinide alone and in combination with metformin in Chinese subjects with type 2 diabetes naive to oral antidiabetes therapy. Methods: A 16-week, open-label, randomized, active-controlled, parallel-group trial was carried out.
Improved glycemic control induced by both metformin and repaglinide is associated with a reduction in blood levels of 3-deoxyglucosone in nonobese patients with type 2 diabetes. [2011.03]
OBJECTIVE: Metformin has been reported to reduce alpha-dicarbonyls, which are known to contribute to diabetic complications. It is unclear whether this is due to direct quenching of alpha-dicarbonyls or to an improvement in glycemic control. We therefore compared the effects of metformin versus repaglinide, an antihyperglycemic agent with an insulin-secreting mechanism, on the levels of the alpha-dicarbonyl 3-deoxyglucosone (3DG)... CONCLUSION: Improved glycemic control induced by both metformin and repaglinide is associated with a reduction in 3DG levels in nonobese individuals with type 2 diabetes. This may constitute a shared metabolic pathway through which both treatments have a beneficial impact on the cardiovascular risk.
Effect of repaglinide and gliclazide on glycaemic control, early-phase insulin secretion and lipid profiles in. [2011.01]
BACKGROUND: Both repaglinide and gliclazide are insulin secretagogues widely used in the treatment of type 2 diabetes. They stimulate insulin secretion through distinct mechanisms and may benefit patients from different aspects. The present study was to evaluate the effects of repaglinide or gliclazide on glycaemic control, insulin secretion, and lipid profiles in type 2 diabetes patients... CONCLUSIONS: Repaglinide and gliclazide had similar effects on glycaemic control and total insulin secretion, while repaglinide had more effects on improvements in beta-cell function and lipid metabolism.
Effect of repaglinide versus glyburide on postprandial glucose and insulin values in elderly patients with type 2 diabetes. [2011.01]
BACKGROUND: studies in younger patients with diabetes have shown that insulin profiles are more physiologic and postprandial glucose levels are lower with repaglinide than with glyburide. We conducted this study to determine if the differences in insulin/glucose profiles between repaglinide and glyburide were similar or different in the elderly... CONCLUSIONS: we conclude that repaglinide results in a more physiologic insulin profile and less frequent hypoglycemia than glyburide in the elderly.
Effect of the bile acid sequestrant colesevelam on the pharmacokinetics of pioglitazone, repaglinide, estrogen estradiol, norethindrone, levothyroxine, and glyburide. [2010.05]
The purpose of this study was to assess effects of colesevelam on the pharmacokinetics of glyburide, levothyroxine, estrogen estradiol (EE), norethindrone (NET), pioglitazone, and repaglinide in healthy volunteers. Six drugs with a potential to interact with colesevelam were studied in open-label, randomized clinical studies.
Clinical Trials Related to Prandin (Repaglinide)
Comparison of the Effects of Repaglinide and Metformin on Glucose Excursions [Recruiting]
This is a 17 week, randomized, single center, open-label, parallel-group study to compare
glucose excursions and other efficacy and safety parameters of repaglinide thrice daily or
metformin thrice daily in newly diagnosed type 2 diabetes subjects in China.
A Pharmacokinetic Study to Compare Co-administration of Repaglinide and Metformin HCl to Administration of Combination Preparation of Those Two Components [Not yet recruiting]
This is a phase-1, single center, open-label, randomized, single-dose, 2-way crossover
study. The objective of the study is to compare the pharmacokinetic properties after
co-administration of Repaglinide 2mg and Metformin hydrochloride 500mg with administration
of combination preparation of Repaglinide 2mg and Metformin hydrochloride 500mg in 50
healthy male volunteers.
Effect of GlucoNorm vs Glyburide on Post-Prandial Hyperglycemia in Elderly Subjects With Type 2 Diabetes [Recruiting]
The results from the DECODE Study have shown that postprandial (1 - 2 hours after a meal)
hyperglycemia (elevated blood sugar) is more common in elderly people with diabetes than
younger people with diabetes and is the best predictor of the development of complications.
The DECODE Study involved 6941 people who already had diabetes and 702 who did not have
diabetes. Diabetes is diagnosed when the blood sugar 1st thing in the morning is over 7. 0
mmol/L. The DECODE Study showed that people at risk for diabetes can have a normal blood
sugar 1st thing in the morning but have a high blood sugar 2 hours after a meal and that
these people are at risk for developing heart disease and other complications of diabetes.
These people would not be identified as at risk if only a fasting blood sugar is done.
Studies in younger people with diabetes have shown that after a meal, insulin levels are
more like a person without diabetes and glucose (blood sugar) levels are lower with
GlucoNorm than with Glyburide. There is no data available that demonstrates this in elderly
people with type 2 diabetes.
You have been invited to participate in this study because you have type 2 diabetes
controlled by diet and/or exercise or metformin only and are over 65 years of age.
The purpose of this study is to determine whether GlucoNorm has a greater effect than
Glyburide on insulin levels and glucose (blood sugar) levels after a meal in elderly people
with type 2 diabetes who control their diabetes with diet and exercise.
Comparison of the Blood Sugar Lowering Effect Between Repaglinide Plus Metformin and Repaglinide Alone in Type 2 Diabetics Not Previously Treated With Oral Sugar-Lowering Drugs (Nil) [Not yet recruiting]
This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood
sugar lowering effect of repaglinide plus metformin as initial treatment compared to
repaglinide alone in Chinese type 2 diabetic patients with an HbA1c over 8. 5 % and who never
have taken oral sugar-lowering drugs before. The associated unfavourable events including low
blood sugar episodes between the two treatments are also compared.
Comparison of Repaglinide and Metformin Combination Tablet Versus Repaglinide and Metformin as Separate Tablets in Healthy Volunteers [Recruiting]
This trial is conducted in Asia. The aim of this clinical trial is to investigate the
bioequivalence of repaglinide and metformin combination tablet versus repaglinide and
metformin as coadministered tablets after meal.
The trial is designed as a three-period, six-sequence, single-dose, crossover
pharmacokinetic trial where the trial participant is randomised to one of six possible
treatment periods (Williams design). The trial participant will receive one single dose of
each trial product in varying order.
Reports of Suspected Prandin (Repaglinide) Side Effects
Pancreatitis (2),
Rash Pruritic (1),
Hypoacusis (1),
Surgery (1),
Skin Discolouration (1),
Hydronephrosis (1),
Nail Discolouration (1),
Disturbance in Attention (1),
Cardiac Arrest (1)
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