Insulin for Obesity

Recruiting in Palo Alto (17 mi)

Overseen by Michael D Jensen, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Mayo Clinic

Must not be taking: Niacin, Thiazolidinediones, Beta-blockers, others

Disqualifiers: Ischemic heart disease, Diabetes, Smokers, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Adults who gain most of their excess weight in the abdominal area typically do not respond to insulin in the same way as lean adults. Researchers are trying to understand why fat tissue responds differently in people with different body types.

Will I have to stop taking my current medications?

The trial requires that you do not take certain medications that can affect fat metabolism, like niacin, thiazolidinediones, beta-blockers, and steroids. If you're on these, you may need to stop them to participate.

Is insulin safe for use in humans?

Research shows that insulin, including types like insulin lispro and insulin detemir, is generally safe for humans. Studies have found no significant differences in safety between insulin lispro and regular human insulin, and basal insulin analogues have a favorable safety profile in people with type 2 diabetes. ^{1 2 3 4 5}

How does the drug insulin differ from other treatments for obesity?

Insulin, typically used for diabetes, is unique in obesity treatment because it involves using various insulin analogues that have different onset and duration of action, potentially affecting metabolism and other cellular processes differently than standard obesity treatments. However, the clinical significance of these differences in treating obesity is not yet clear. ^{1 6 7 8 9}

Research Team

Michael D Jensen, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for overweight or obese adults aged 18-65 with a BMI of 29.0 - 37.0, who carry extra weight mainly in the abdominal area. Participants must follow a specific diet for three days before the study and be able to understand and follow instructions. Pregnant or nursing women, smokers, those with certain allergies, high blood pressure not controlled by medication, heart disease history, diabetes diagnosis, or on drugs affecting fat metabolism cannot join.

Inclusion Criteria

I will eat only provided meals from Mayo CRTU for 3 days before the study.

Lower body obesity (LBO) criteria for women and men

My BMI is between 29.0 and 37.0.

Exclusion Criteria

Smokers

Allergy to indocyanine green

Allergy to lidocaine

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Measure regional free fatty acid (FFA) release in volunteers under different conditions

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

• Insulin (Hormone Therapy)

Trial Overview Researchers are studying how insulin affects fat tissue in people with different body types—specifically comparing responses between those who gain weight primarily in their abdomen versus other areas.

Participant Groups

Group I: obesity status Experimental Treatment 1 Intervention

obesity

Group II: lean Experimental Treatment 1 Intervention

non-obese

Insulin is already approved in Canada for the following indications:

Approved in Canada as Insulin for:

• Diabetes mellitus

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Medical Officer since 2007

MD, M.A.C.P.

Findings from Research

In a 32-week study involving 686 patients with Type 2 diabetes, insulin detemir (IDet) therapy was found to be safe, with no serious adverse drug reactions reported and a significant reduction in total hypoglycemic events from 435 to 204.

Patients experienced improved glycemic control, as indicated by a decrease in glycated hemoglobin A1c from 9.9% to 7.7% and fasting plasma glucose from 11.9 mmol/L to 7.4 mmol/L, alongside a slight reduction in body weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical safety of insulin detemir in patients with Type 2 diabetes in the Gulf countries: The multicenter, noninterventional, open-label LevSafe study. El Shiekh, AR., Farrag, HA., Ashour, T., et al.[2020]

A comparison of insulin lispro and regular human insulin (Humulin R) in 3634 patients with type 1 and type 2 diabetes showed no significant differences in treatment-emergent adverse events, indicating similar safety profiles for both insulins.

Both insulin therapies did not differ in their effects on the progression of chronic diabetes complications, such as retinopathy, neuropathy, cardiovascular disease, or kidney disease, suggesting that insulin lispro is as safe as Humulin R.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of insulin lispro: pooled data from clinical trials. Glazer, NB., Zalani, S., Anderson, JH., et al.[2019]

In a study of 460 adults with type 2 diabetes who were previously inadequately controlled on other insulin types, initiating basal insulin analogues led to a significant reduction in glycated hemoglobin (HbA1c) by 1.8% over 6 months, indicating improved glycemic control.

The use of basal insulin analogues also significantly decreased the incidence of symptomatic hypoglycemia from 96.3% to 15.4%, while not adversely affecting body weight, waist circumference, or BMI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Benefit of Basal Insulin Analogue Treatment in Persons with Type 2 Diabetes Inadequately Controlled on Prior Insulin Therapy: A Prospective, Noninterventional, Multicenter Study. Bjekić-Macut, J., Živković, TB., Kocić, R.[2020]

In a study involving 1008 patients, short-acting insulin lispro and regular insulin Humulin R showed similar effectiveness in controlling blood sugar levels and had comparable safety profiles, with no significant differences in hypoglycemia incidents.

After a year of continued lispro therapy, glycosylated hemoglobin (HbA1C) levels returned to baseline, indicating that while lispro was well tolerated in the short term, long-term efficacy may need further evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lispro insulin as premeal therapy in type 1 diabetes: comparison with Humulin R. Daniels, AR., Bruce, R., McGregor, L.[2022]

Insulin detemir is an effective long-acting insulin for managing type 2 diabetes, providing consistent blood glucose control for up to 24 hours while reducing the risk of nocturnal hypoglycemia and weight gain compared to other basal insulins.

Properly titrated insulin therapy, including insulin detemir, is the most physiological approach to lowering blood glucose and may help preserve beta-cell function, addressing common concerns about insulin use in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin detemir: a new option for the treatment of diabetes. Funnell, MM.[2022]

Treatment with humulin insulins showed high clinical effectiveness in managing diabetes, as evidenced by decreased insulin doses, stable diabetes compensation, and a reduction in insulin antibodies.

Humulin insulins are preferred over iletin-II due to their low immunogenicity, which means they are less likely to provoke an immune response and complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of highly purified Iletin-II-type porcine insulins and human insulin preparations in clinical practice]. Petunina, NA., Balabolkin, MI., Mkrtumian, AM., et al.[2011]

Insulin detemir is a long-acting insulin analog developed by Novo Nordisk for treating type 1 and type 2 diabetes, showing promise for effective blood sugar management.

As of early 2003, regulatory submissions for approval were made to both the FDA and Canadian authorities, indicating a strong push towards making this treatment available to patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin detemir. Novo Nordisk. Barlocco, D.[2015]

References

1. England pubmed.ncbi.nlm.nih.gov

Differences in bioactivity between human insulin and insulin analogues approved for therapeutic use- compilation of reports from the past 20 years. [2021]

2. India pubmed.ncbi.nlm.nih.gov

Clinical safety of insulin detemir in patients with Type 2 diabetes in the Gulf countries: The multicenter, noninterventional, open-label LevSafe study. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Safety of insulin lispro: pooled data from clinical trials. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical Benefit of Basal Insulin Analogue Treatment in Persons with Type 2 Diabetes Inadequately Controlled on Prior Insulin Therapy: A Prospective, Noninterventional, Multicenter Study. [2020]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Lispro insulin as premeal therapy in type 1 diabetes: comparison with Humulin R. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Update on insulin analogues. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Insulin detemir: a new option for the treatment of diabetes. [2022]

8. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The use of highly purified Iletin-II-type porcine insulins and human insulin preparations in clinical practice]. [2011]

9. England pubmed.ncbi.nlm.nih.gov

Insulin detemir. Novo Nordisk. [2015]