Method of treating diabetes type 2 by administering ultrarapid acting insulin
Inventors
Richardson, Peter • Baughman, Robert A. • Potocka, Elizabeth • Boss, Anders Hasager • Petrucci, Richard
Assignees
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Publication Number
US-11998591-B2
Publication Date
2024-06-04
Expiration Date
Abstract
Disclosed herein are improved methods of treating hyperglycemia with a combination of an ultrarapid acting insulin and insulin glargine comprising prandial administration of the ultrarapid insulin, and administration of a first dose of insulin glargine within 6 hours of waking for a day.
Core Innovation
The invention describes treating diabetes type 2 in a subject who has well or moderately controlled fasting blood glucose (FBG) but poorly controlled post-prandial glucose (PPG), with an aim of avoiding weight gain while improving glycemic control. The approach includes patient selection and a treatment regimen that uses an ultrarapid acting insulin (URAI) preparation administered with at least one established meal.
The invention specifies selecting subjects currently being treated with metformin but not a basal insulin, or with a suppressor of hepatic glucose output together with an insulin secretagogue, and having an HbA1c level less than or equal to 8.4%. The regimen then either combines metformin with URAI or discontinuing the insulin secretagogue and replacing it with routine URAI administration with meals.
The disclosed URAI preparation is an insulin-FDKP/TECHNOSPHERE® inhalation dry powder, where fumaryl diketopiperazine (FDKP) is associated with insulin and the insulin is delivered pulmonarily as a dry powder. The invention frames the intended benefit around rapid meal-related insulin kinetics, with faster inhibition of endogenous glucose production and faster glucose utilization compared with insulin lispro and EXUBERA®, together with trial results indicating comparable HbA1c control, reduced post-prandial excursions, and improved weight and hypoglycemia outcomes.
Claims Coverage
The independent claims are clm-00001 and clm-00006. Each claim centers on selecting a diabetes type 2 subject defined by FBG/PPG status and HbA1c threshold, and then routinely administering an ultrarapid acting insulin (URAI) preparation with at least one established meal to achieve reduced weight gain compared to the respective comparator treatment.
Patient selection with controlled FBG but poorly controlled PPG on metformin
Selecting a subject with diabetes type 2 who has well or moderately controlled fasting blood glucose (FBG) but poorly controlled post-prandial glucose (PPG), currently being treated with metformin but not a basal insulin, having an HbA1c level less than or equal to 8.4%, and being in need of improved glycemic control and avoiding weight gain.
Routine combination of metformin with ultrarapid acting insulin at meals to reduce weight gain
Instead combining treatment with metformin with routinely administering an ultrarapid acting insulin (URAI) preparation with at least one established meal, wherein the treatment results in reduced weight gain as compared to metformin treatment alone.
Patient selection with controlled FBG but poorly controlled PPG on hepatic glucose output suppressor plus insulin secretagogue
Selecting a subject with diabetes type 2 who has well or moderately controlled fasting blood glucose (FBG) but poorly controlled post-prandial glucose (PPG), currently being treated with a suppressor of hepatic glucose output and an insulin secretagogue, having an HbA1c level less than or equal to 8.4%, and needing to avoid weight gain.
Discontinuation of insulin secretagogue and routine ultrarapid acting insulin with meals to reduce weight gain
Discontinuing treatment with the insulin secretagogue and routinely administering an ultrarapid acting insulin (URAI) preparation with at least one established meal, wherein the treatment results in reduced weight gain as compared to treatment with the suppressor of hepatic glucose output and insulin secretagogue.
Across the independent claims, the core coverage is defined by selecting diabetes type 2 subjects with controlled fasting glucose but poorly controlled post-prandial glucose (HbA1c ≤ 8.4%) and then using meal-associated ultrarapid acting insulin (URAI) as either a metformin combination strategy or as a replacement after discontinuing an insulin secretagogue, with the explicit outcome of reduced weight gain relative to the comparator regimen.
Stated Advantages
Reduced weight gain compared to metformin treatment alone (claim 1).
Reduced weight gain compared to treatment with a suppressor of hepatic glucose output and an insulin secretagogue (claim 6).
Documented Applications
Treating diabetes type 2 in subjects with well or moderately controlled fasting blood glucose but poorly controlled post-prandial glucose, while avoiding weight gain, by selecting appropriate patients and administering ultrarapid acting insulin (URAI) with at least one established meal.
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