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New Oral Treatment May Help with Managing HbA1c for Type 1 Diabetes

Keeping HbA1c levels within a healthy range can be challenging for those living with type 1 diabetes. It requires constant vigilance when it comes to monitoring blood sugar levels and administering the appropriate amount of insulin. Even with careful management, there can be complications.

A recent study found that a once-daily pill used in conjunction with insulin may help reduce HbA1c levels by as much as 0.32% after 12 weeks.  The pill, known as TTP399, activates glucokinase in the liver.  This, in turn, stimulates the body to improve glucose utilization which can lead to lower blood glucose levels. Overall, this could help improve HbA1c levels as well as time spent within a healthy glucose range.

A randomized, double-blind, adaptive study compared participants taking the TTP399 pill versus those on a placebo.  Those who received the pill showed improved glucose response and fewer symptomatic hypoglycemic episodes.  The average improvement in HbA1c was 0.21%, and there was also an average of an 11% reduction in the dosage amount of total daily mealtime bolus insulin needed.

On the other hand, the placebo group showed a 0.11% increase in HbA1c after the 12-week trial period.  Neither group reported any incidences of diabetic ketoacidosis, and there was only one incident of severe hypoglycemia, which occurred in the placebo group.

This phase 2 study involved 85 participants. They were all currently either administering daily injections or using an insulin pump.  If they were using a continuous glucose monitor (CGM), they had to be on it for at least three months prior to the start of the study to be included.

According to Steve Holcomb, president and CEO of vTv Therapeutics, “Consistent with FDA guidance, a 0.3% improvement in HbA1c is considered clinically meaningful and coupled with the well-controlled population of patients and favorable safety data from our clinical trials to date, this provides a strong basis for moving this potential first-in-class program forward.”

The pill could be used in conjunction with insulin therapy as a way of further managing and reducing HbA1c levels. This an exciting step forward in terms of type 1 diabetes management and supporting individuals in staying within healthy ranges for HbA1c and daily blood sugar levels.

Diabetes Research Connection (DRC), though not involved with this study, is interested to see how it evolves moving forward, and what it could mean for the future of oral treatment involving noninsulin products.

Research for type 1 diabetes continues to improve and advance every single day, and DRC helps makes this possible by providing critical funding to early-career scientists pursuing novel research studies on type 1 diabetes.  Through generous donations from individuals, corporations, and foundations, they are able to provide researchers with up to $50K in funding to support studies aimed at improving prevention measures, enhancing quality of life, reducing complications, and finding a cure. Learn more by visiting https://diabetesresearchconnection.org.

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Could Higher-Dose and Lower-Dose Insulin Glargine be Equally Effective in Managing Type 1 Diabetes?

In an effort to maintain greater blood-glucose stability throughout the day and minimize highs and lows, some individuals with type 1 diabetes use insulin glargine, which is a once-a-day, long-acting insulin. It is an analogue, or laboratory-created, insulin which has been modified to act more uniformly in managing glucose levels.

Insulin glargine comes in varying strengths, and a recent study found that there were no significant differences in safety or effectiveness between insulin glargine 100 U/mL and insulin glargine 300 U/mL when administered in children and adolescents. Data from 463 EDITION JUNIOR study participants between the ages of 6 and 17 were compared over 26 weeks. Of those participants, 233 were randomly assigned to insulin glargine 300 U/mL, and 228 were randomly assigned to insulin glargine 100 U/mL. Both groups continued to follow their normal routine for mealtime insulin but injected insulin glargine once per day.

Results showed that all participants experienced a reduction in HbA1c levels over the 26 weeks. However, there were fewer instances of severe hypoglycemia among participants using the insulin glargine 300 U/mL, though overall, results were comparable between groups. Both insulins were effective in achieving target study endpoints and did not demonstrate any unexpected safety concerns.

In comparing insulin glargine 100 U/mL and insulin glargine 300 U/mL, researchers may be able to use insulin glargine 300 U/mL as yet another treatment option for children and adolescents with type 1 diabetes. It is currently under review by the FDA, and researchers are evaluating data from a six-month safety follow-up.

It is encouraging to see that more options are being explored to meet the needs of individuals living with type 1 diabetes in order to maintain target glucose levels with fewer fluctuations. Diabetes Research Connection (DRC) will continue to follow these types of studies to see how they impact the future of diabetes management and accessibility to care.

DRC provides critical funding for early career scientists pursuing novel, peer-reviewed research studies for type 1 diabetes. Projects aim to improve prevention and treatment of the disease, as well as enhance quality of life and eventually find a cure. To learn more about current studies and support these efforts, visit http://diabetesresearchconnection.org.

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