No pediatric clinical studies have been conducted with FORTAMET®. The safety and effectiveness of immediate-release metformin for the treatment of type 2 diabetes have been established in pediatric patients ages 10 to 16 years (studies have not been conducted in pediatric patients below the age of 10 years). Use of immediate-release metformin in this age group is supported by evidence from adequate and well-controlled studies of immediate-release metformin in adults with additional data from a controlled clinical study in pediatric patients ages 10-16 years with type 2 diabetes, which demonstrated a similar response in glycemic control to that seen in adults (see CLINICAL PHARMACOLOGY: Pediatric Clinical Studies). In this study, adverse effects were similar to those described in adults (see ADVERSE REACTIONS: Pediatric Patients). A maximum daily dose of 2000 mg of immediate-release metformin is recommended.
The safety and efficacy of FORTAMET® has not been evaluated in pediatric patients.
Of the 389 patients who received FORTAMET® in controlled Phase III clinical studies, 26.5% [103/389] were 65 years and older. No overall differences in effectiveness or safety were observed between these patients and younger patients.
Controlled clinical studies of immediate-release metformin did not include sufficient numbers of elderly patients to determine whether they respond differently from younger patients, although other reported clinical experience has not identified differences in responses between the elderly and younger patients. Metformin is known to be substantially excreted by the kidney and because of the risk of serious adverse reactions to the drug is greater in patients with impaired renal function, immediate-release metformin should only be used in patients with normal renal function (see CONTRAINDICATIONS, WARNINGS, and CLINICAL PHARMACOLOGY: Pharmacokinetics). Because aging is associated with reduced renal function, immediate-release metformin should be used with caution as age increases. Care should be taken in dose selection and should be based on careful and regular monitoring of renal function. Generally, elderly patients should not be titrated to the maximum dose of immediate-release metformin (see also WARNINGS and DOSAGE AND ADMINISTRATION).
In the controlled clinical studies of FORTAMET® in patients with type 2 diabetes, a total of 424 patients received FORTAMET® therapy (up to 2500 mg/day) and 430 patients received immediate-release metformin. Adverse reactions reported in ≥5% of the FORTAMET® or immediate-release metformin patients are listed in Table 6. These pooled results show that the most frequently reported adverse reactions in the FORTAMET® group were infection, diarrhea, and nausea. Similar incidences of these adverse reactions were seen in the immediate-release metformin group.
|FORTAMET® (N=424)||Immediate-Release Metformin (N=430)|
|Body System Preferred Term||n||(%)||n||(%)|
|Body as a Whole|
The most frequent adverse events thought to be related to FORTAMET® were diarrhea, nausea, dyspepsia, flatulence, and abdominal pain. The frequency of dyspepsia was 4.2% in the FORTAMET® group compared to 5.1% in the immediate-release group, the frequency of flatulence was 3.5% in the FORTAMET® group compared to 3.7% in the immediate-release group, and the frequency of abdominal pain was 3.3% in the FORTAMET® group compared to 4.4% in the immediate-release group.
In the controlled studies, 4.7% of patients treated with FORTAMET® and 4.9% of patients treated with immediate-release metformin were discontinued due to adverse events.
Immediate-Release Metformin Phase III Clinical Studies
In a U.S. double-blind clinical study of immediate-release metformin in patients with type 2 diabetes, a total of 141 patients received immediate-release metformin therapy (up to 2550 mg per day) and 145 patients received placebo. Adverse reactions reported in greater than 5% of the immediate-release metformin patients, and that were more common in immediate-release metformin than placebo-treated patients, are listed in Table 7.
|Immediate-Release MetforminMonotherapy(n = 141)||Placebo(n = 145)|
|Adverse Reaction||% of Patients|
* Reactions that were more common in immediate-release metformin that placebo-treated patients
Diarrhea led to discontinuation of study medication in 6% of patients treated with immediate-release metformin. Additionally, the following adverse reactions were reported in ≥1.0 — ≤5.0% of immediate-release metformin patients and were more commonly reported with immediate-release metformin than placebo: abnormal stools, hypoglycemia, myalgia, lightheaded, dyspnea, nail disorder, rash, sweating increased, taste disorder, chest discomfort, chills, flu syndrome, flushing, palpitation.
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