In a statement from Janssen Pharmaceuticals, Inc. today, the company announced that the U.S. Food and Drug Administration (FDA) has approved INVOKAMET® XR — a once-daily, fixed-dose combination therapy of canagliflozin and metformin hydrochloride extended-release (XR) — for first-line use as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes when treatment with the two medications is appropriate.
INVOKAMET XR combines canagliflozin (INVOKANA) and an XR formulation of metformin. Metformin is commonly prescribed as an initial therapy for the treatment of type 2 diabetes.
This new combination therapy offers a “… once-daily dosing and provides physicians flexibility for tailoring treatment to the needs of type 2 diabetes patients, especially those with higher A1C levels,” said John Anderson, MD, Frist Clinic, Nashville, Tenn. “[P]hysicians can prescribe the XR formulation to adults when they are first diagnosed with type 2 diabetes or as additional therapy for people whose A1C levels are not well controlled with either agent alone.”
Phase 3 studies [see below] have shown the combination of canagliflozin and metformin reduces A1C significantly more than metformin alone, sitagliptin plus metformin, or glimepiride plus metformin. Treatment with canagliflozin as an add-on to metformin also demonstrated greater reductions in the secondary endpoints of body weight and systolic blood pressure.
The approved indication for INVOKAMET XR aligns with current type 2 diabetes treatment guidelines from the American Association of Clinical Endocrinologists and American College of Endocrinology and from the American Diabetes Association, which recommend dual therapy for patients with higher A1C levels. Specifically, guidelines recommend dual therapy for patients who have an initial A1C level of 7.5% or higher and for those who have an initial level below 7.5% and do not achieve an A1C treatment goal after about three months on single therapy, often metformin. In addition, dual or triple therapy is recommended as first-line therapy in asymptomatic patients with an initial A1C level above 9%
For more information, please see full product information and medication guide.
About the Phase 3 Studies of Canagliflozin-Metformin Therapy
The co-administration of canagliflozin and metformin has been evaluated in seven Phase 3 studies. One study included 1,186 adults with type 2 diabetes inadequately controlled with diet and exercise, and who had not been treated previously with any glucose-lowering medications; the six other studies included 4,732 patients with type 2 diabetes who were already taking glucose-lowering medications. Collectively, the Phase 3 studies showed that the combination of canagliflozin and metformin lowered blood sugar and, in pre-specified secondary endpoints, was associated with greater reductions in body weight and systolic blood pressure.
The Phase 3 studies also showed that canagliflozin is generally well-tolerated, and the most common adverse events include genital yeast infections, urinary tract infections, and changes in urination. The most common adverse reactions due to initiation of metformin, as noted in the prescribing information for that medication, are diarrhea, nausea, vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache. Hypoglycemia does not occur in patients receiving metformin alone under usual circumstances of use. Canagliflozin can increase the risk of hypoglycemia when combined with insulin or a medication that increases insulin levels (e.g., a sulfonylurea). Therefore, a lower dose of insulin or insulin-raising medication may be required to minimize the risk of hypoglycemia when used in combination with INVOKAMET XR.
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