Methods of preventing progression to type 2 diabetes mellitus
Inventors
Day, Wesley • TROUPIN, Barbara
Assignees
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Publication Number
US-9724327-B2
Publication Date
2017-08-08
Expiration Date
Abstract
The present invention provides compositions and methods for delaying or preventing progression to type 2 diabetes mellitus in individuals with prediabetes and metabolic syndrome.
Core Innovation
The invention relates to a method of delaying or preventing the onset of type 2 diabetes in a patient. The method includes identifying a patient at risk for developing type 2 diabetes, where the patient has a body mass index (BMI) of 25 kg/m² or less, and administering an oral dosage form containing immediate release phentermine and controlled release topiramate.
The oral dosage form comprises immediate release phentermine together with controlled release topiramate, including phentermine/topiramate extended-release (PHEN/TPM ER) dosing pairings. The document describes preferred dose pairings of 3.75 mg/23 mg, 7.5 mg/46 mg, 11.25 mg/69 mg, and 15 mg/92 mg daily, with titration and maintenance scheduling within the regimen.
The clinical context addresses patients with prediabetes and metabolic syndrome (MetS). Diagnostic criteria for prediabetes include HbA1c, impaired glucose tolerance on OGTT, and impaired fasting glucose, and diagnostic criteria for MetS include waist circumference, triglycerides, HDL-C, blood pressure, and fasting glucose.
Claims Coverage
The partial claim set includes one independent claim. The independent claim requires a method for delaying or preventing type 2 diabetes using an oral dosage form comprising immediate release phentermine and controlled release topiramate, with an at-risk patient defined by BMI.
BMI-defined at-risk patient selection
Identifying a patient at risk for developing type 2 diabetes, wherein the patient has a body mass index (BMI) of 25 kg/m² or less.
Oral immediate release phentermine and controlled release topiramate dosage form
Administering to the patient an oral dosage form comprising immediate release phentermine and controlled release topiramate.
Across the available independent claim, the inventive concept is anchored by selecting patients with BMI ≤ 25 kg/m² and administering an oral dosage form combining immediate release phentermine with controlled release topiramate.
Stated Advantages
Delays or prevents the onset of type 2 diabetes versus placebo in the described SEQUEL subgroup analysis with lifestyle modification.
Produces substantial weight loss.
Markedly reduces cumulative and annualized incidence of type 2 diabetes versus placebo.
Improves glycemia/insulin sensitivity and cardiometabolic risk factors, including blood pressure, waist, triglycerides, and HDL-C.
Improves inflammatory markers, including hs-CRP and fibrinogen.
Improves adiponectin.
Reduces MetS severity and supports MetS remission.
Generally well tolerated.
Documented Applications
Delaying or preventing type 2 diabetes in patients with prediabetes and metabolic syndrome (MetS) using an oral PHEN/TPM ER regimen with lifestyle modification, with outcomes evaluated in the SEQUEL subgroup analysis.
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