Understanding Type 2 Diabetes

Insulin Production and Function

Individuals with type 2 diabetes either do not produce sufficient insulin or their bodies fail to respond effectively to the insulin that is produced. Insulin, a vital hormone, is responsible for regulating blood glucose levels and is produced and stored in the beta cells of the pancreas. In cases of type 2 diabetes, these beta cells malfunction, leading to inadequate insulin production and elevated blood glucose levels.

Insulin Therapy Options

Management Approaches

While some individuals with type 2 diabetes can control their blood glucose levels through diet and exercise, others may require medications or insulin therapy. The goal of insulin therapy is to keep blood glucose levels within a target range by administering insulin through injections.

Types of Insulin Regimens

There are various insulin therapy regimens tailored to the severity of the condition. Typically, patients begin with a long-acting insulin shot before bedtime, while short-acting insulin may be administered just before or after meals. Additionally, some individuals opt for insulin pumps that deliver insulin via a plastic tube placed under the abdomen. For those seeking a more intensive treatment approach, multiple daily insulin doses can be utilized, known as intensive insulin therapy.

Intermittent Insulin Therapy Research

Previous Findings

Research indicates that administering insulin injections for a limited duration may protect the pancreas’s beta cells, enabling individuals with type 2 diabetes to maintain stable blood sugar levels for extended periods without medication. However, this protective effect tends to be temporary.

Current Clinical Trial: RESET IT

A clinical trial named RESET IT, led by Canadian physicians Dr. Ravi Retnakaran and Dr. Bernard Zinman at Mount Sinai Hospital in Toronto, is currently investigating how to sustain this remission and potentially alter the progression of type 2 diabetes. The study focuses on whether intermittent insulin therapy can preserve beta cell function in early-stage type 2 diabetes.

Study Design

This phase III, randomized controlled trial will assign participants randomly into one of two groups:
– Metformin alone
– Metformin combined with Intermittent Insulin Therapy

Metformin is commonly the first-line medication prescribed for type 2 diabetes, improving insulin sensitivity and reducing glucose production by the liver.

The group receiving only metformin will first undergo three weeks of intensive insulin therapy, followed by metformin treatment starting at 500 mg daily for the first two weeks and increasing to 1000 mg twice daily for the remainder of the 24-month trial.

Conversely, the group receiving both metformin and intermittent insulin will also start with three weeks of intensive insulin therapy. Afterward, they will take metformin at 500 mg twice daily for the first two weeks, transitioning to 1000 mg twice daily for the trial duration. However, participants in this group will need to pause metformin intake for two weeks every three months while receiving intermittent intensive insulin therapy for those two weeks. This two-week insulin therapy cycle will be repeated at designated intervals throughout the trial duration.

Study Outcomes

Primary and Secondary Outcomes

The primary outcome of the study is to evaluate beta cell function, measured using the Insulin Secretion-Sensitivity Index-2 (ISSI-2). Secondary outcomes will assess glycemic control through glycated hemoglobin levels in the blood. Additional metrics include achieving target glycemic control, achieving glucose tolerance in non-diabetic ranges, and measuring insulin sensitivity.

Participant Enrollment

Sponsored by Mount Sinai Hospital in Toronto, the study aims to enroll 148 eligible participants, with completion anticipated by September 2020.

References

(1) “Early Intermittent Intensive Insulin Therapy As An Effective Treatment Of Type 2 Diabetes (RESET-IT Main Trial) – Full Text View – Clinicaltrials.Gov.” Clinicaltrials.Gov, 2018, https://clinicaltrials.gov/ct2/show/NCT02192424?term=type+2+diabetes&recrs=ab&cntry=CA&draw=2&rank=2.
(2) “Research Studies — Mount Sinai Hospital – Toronto.” Mount Sinai Hospital, 2018, http://www.mountsinai.on.ca/care/lscd/research-studies/clinical-trials.
(3) “Living With Type 2 Diabetes.” Canadian Diabetes Association, 2018, http://www.diabetes.ca/diabetes-and-you/living-with-type-2-diabetes.
(4) “My Site – Appendix 3: Examples Of Insulin Initiation And Titration Regimens In People With Type 2 Diabetes.” Guidelines.Diabetes.Ca, 2018, http://guidelines.diabetes.ca/browse/appendices/appendix3.
(5) “Type 2 Diabetes – Diagnosis And Treatment – Mayo Clinic.” Mayoclinic.Org, 2018, https://www.mayoclinic.org/diseases-conditions/type-2-diabetes/diagnosis-treatment/drc-20351199.