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.
|
NEWS HIGHLIGHTS
Published Studies Related to Prandin (Repaglinide)
Twice-daily and three-times-daily dosing of a repaglinide/metformin fixed-dose combination tablet provide similar glycaemic control. [2009.10]
AIM: To assess the efficacy and safety of a new repaglinide/metformin fixed-dose combination (FDC) tablet administered either twice a day (BID) or three times a day (TID) for the management of type 2 diabetes... CONCLUSION: The efficacy of twice-daily dosing of a repaglinide/metformin FDC tablet was non-inferior to that of three-times-daily dosing.
Twice-daily dosing of a repaglinide/metformin fixed-dose combination tablet provides glycaemic control comparable to rosiglitazone/metformin tablet. [2009.09]
AIM: To assess the use of a new repaglinide/metformin fixed-dose combination (FDC) tablet for the treatment of type 2 diabetes... CONCLUSIONS: The repaglinide/metformin FDC BID regimen showed efficacy that was non-inferior to that of the rosiglitazone/metformin FDC BID regimen currently in clinical use and a more rapid reduction of HbA1c values. Thus, repaglinide/metformin FDC BID is a clinically feasible alternative to rosiglitazone/metformin FDC BID.
The investigation of the efficacy of insulin glargine on glycemic control when combined with either repaglinide or acarbose in obese Type 2 diabetic patients. [2009.01]
Combinations of insulin and oral antidiabetic drugs (OAD) are often prescribed instead of insulin alone. In this study, the effects of insulin glargine (IG) in combination with repaglinide or acarbose on glycemic parameters were investigated... Furthermore, acarbose seems to have advantages over repaglinide concerning weight gain and severe hypoglycemic attacks.
Effects of gemfibrozil and atorvastatin on the pharmacokinetics of repaglinide in relation to SLCO1B1 polymorphism. [2008.10]
In a randomized crossover study, 24 SLCO181-genotyped healthy volunteers were given daily doses of 1,200 mg gemfibrozil, 40 mg atorvastatin, or placebo, followed by 0.25 mg of repaglinide on day 3. The mean increase in the repaglinide area under the plasma concentration-time curve from 0 h to infinity (AUC(0-infinity)) produced by gemfibrozil was larger in individuals with the SLCO1B1 c.521CC genotype (n = 6) than in those with the c.521TC (n = 6) and c.521TT (n = 12) genotypes, by factors of 1.56 (P = 0.004) and 1.54 (P = 0.002), respectively...
The effect of gemfibrozil on repaglinide pharmacokinetics persists for at least 12 h after the dose: evidence for mechanism-based inhibition of CYP2C8 in vivo. [2008.09]
Repaglinide is metabolized by cytochrome P450 (CYP) 2C8 and 3A4...
Clinical Trials Related to Prandin (Repaglinide)
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.
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.
Repaglinide for Adolescents With Cystic Fibrosis-Related Diabetes [Terminated]
This study will test the hypothesis that oral repaglinide is equivalent to insulin in the
treatment of new-onset CFRD in adolescents. In addition, successful treatment of CFRD with
repaglinide will improve nutritional status, ameliorate declines in pulmonary function, and
will not have a negative impact upon quality of life.
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.
|
