WARNING: LACTIC ACIDOSIS
Lactic acidosis is a rare but serious complication that can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure.
The onset of lactic acidosis often is subtle, and accompanied only by nonspecific symptoms such as malaise,
, respiratory distress, increasing somnolence, and nonspecific abdominal distress.
Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate.
If acidosis is suspected,
should be discontinued and the patient hospitalized immediately [see Warnings and Precautions
PrandiMet (repaglinide and metformin HCl) tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes: repaglinide and metformin HCl. The concomitant use of repaglinide and metformin HCl has been previously approved based on clinical trials in patients with type 2 diabetes inadequately controlled on exercise, diet, and metformin HCl alone.
PrandiMet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a meglitinide and metformin HCl or who have inadequate glycemic control on a meglitinide alone or metformin HCl alone.
Important Limitations of Use:
PrandiMet should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.
Published Studies Related to Prandimet (Repaglinide / Metformin)
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.
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.
Safety and efficacy of repaglinide in combination with metformin and bedtime NPH insulin as an insulin treatment regimen in type 2 diabetes. [2008.01]
OBJECTIVE: To evaluate the efficacy and safety of the association of repaglinide, metformin and bedtime NPH insulin compared to two classic regimens: metformin plus NPH and two doses of NPH in patients with poorly controlled type 2 diabetes despite two or more oral antidiabetic drugs (OADs)... CONCLUSIONS: The combination of repaglinide, metformin and bedtime NPH is safe and effective and it provides better postprandial blood glucose control. The association of metformin and a dose of NPH does not obtain suitable control in patients with a long evolution who have already received two or more OADs.
Fixed-Dose Combination Tablet of Repaglinide and Metformin is Bioequivalent to Concomitantly Administered Individual Tablets of Repaglinide and Metformin : Randomized, Single-Blind, Three-Period Crossover Study in Healthy Subjects. 
CONCLUSION: An FDC tablet of repaglinide/metformin 2 mg/500 mg was bioequivalent to individual tablets of repaglinide 2 mg and metformin 500 mg. Additionally, an FDC tablet of repaglinide/metformin 2 mg/500 mg was dose proportional to an FDC tablet of repaglinide/metformin 1 mg/500 mg. Finally, no unexpected safety concerns were noted with repaglinide/metformin combination tablet therapy. Our results suggest that FDC tablets of repaglinide and metformin would provide safety and efficacy comparable to that of repaglinide and metformin administered as separate formulations.
Clinical Trials Related to Prandimet (Repaglinide / Metformin)
Comparison of Repaglinide and Metformin Combination Tablet Versus Repaglinide and Metformin as Separate Tablets in Healthy Volunteers [Completed]
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.
Effect of Repaglinide and Metformin Combination Tablet or Rosiglitazone and Metformin in Fixed Dose Combination on Blood Glucose Control in Patients With Type 2 Diabetes [Completed]
This trial is conducted in the United States of America (USA). This trial compares the
changes in HbA1c after 26 weeks of repaglinide and metformin fixed dose combination tablet
given as twice daily versus three times daily regimens or versus twice daily rosiglitazone
and metformin fixed dose combination tablet in subjects with type 2 diabetes currently on
Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet in Fed Healthy Volunteers [Completed]
Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet in Healthy Volunteers [Completed]
This trial is conducted in the United States of America (USA). The aim of this trial is to
compare repaglinide and metformin administered as an individual tablets with repaglinide and
metformin administered as a combination tablet.
Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes [Completed]
This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of
blood glucose control with combination therapy of repaglinide and metformin compared to
conventional treatment with a sulphonylurea or metformin in monotherapy in type 2 diabetes
Page last updated: 2011-12-09