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New treatment option for Type 2 Diabetes
Official title Exercise and Intranasal Insulin in Type 2 Diabetes
ClinicalTrials.gov ID: NCT07675499
What this study is testing
What is Intranasal Insulin?
Intranasal Insulin is an investigational medicine, being studied as a potential treatment for type 2 diabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- About 6.5 million adults in the United States who are 65 or older have dementia. While the exact cause of dementia is not known, it may be due to changes in the brain.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 80
You may be able to join if
- Male or female 55-80 years old
- Type 2 diabetes diagnosis or confirmation HbA1c \>6.5% and fasting glucose \>126 mg/dl
- Individuals prescribed metformin, GLP-1 agonists (oral/injectable), TZDs, DPP-IV inhibitors, Acarbose, SGLT-2 inhibitors \>6 months.
- MOCA ≥26
- Body mass index (BMI) ≥25 and ≤40 kg/m2
You likely can't join if
- A diagnosis of dementia
- Neurologic disease (e.g. Parkinson's, autonomic neuropathy, etc.)
- Intolerance to insulin
- Morbidly obese patients (BMI \>40 kg/m2) and lean patients (BMI \<25 kg/m2)
- \>2 kg weight change in past 6 months
- Participants who have been recently active (\>90 min of moderate/high intensity exercise)
See the full eligibility criteria
- Male or female 55-80 years old
- Type 2 diabetes diagnosis or confirmation HbA1c \>6.5% and fasting glucose \>126 mg/dl
- Individuals prescribed metformin, GLP-1 agonists (oral/injectable), TZDs, DPP-IV inhibitors, Acarbose, SGLT-2 inhibitors \>6 months.
- MOCA ≥26
- Body mass index (BMI) ≥25 and ≤40 kg/m2
- Not diagnosed with Type 1 diabetes
- Not currently engaged in \<90 min/wk of exercise
- A diagnosis of dementia
- Neurologic disease (e.g. Parkinson's, autonomic neuropathy, etc.)
- Intolerance to insulin
- Morbidly obese patients (BMI \>40 kg/m2) and lean patients (BMI \<25 kg/m2)
- \>2 kg weight change in past 6 months
- Participants who have been recently active (\>90 min of moderate/high intensity exercise)
- Individuals who are smokers or who have quit smoking (\<2 years)
- Hypertriglyceridemia (400 mg/dl) and hypercholesterolemic (\>260 mg/dl) people
- Uncontrolled Hypertensive (\>160/100 mmHg)
- Participants with a history of significant metabolic, cardiac, cerebrovascular, hematological, pulmonary, gastrointestinal, liver, renal, or endocrine disease or cancer that in the investigator's opinion would interfere...
- Pregnant (as evidenced by positive pregnancy test) or nursing women
- Participants with contraindications to participation in an exercise training program
- Major psychiatric disorders (e.g. psychosis, bipolar disorder, major depression, alcohol/substance abuse)
- History of head trauma or loss of consciousness in last 5 years.
- Known contraindications for MR imaging:
- History of head trauma or neurosurgery, or neurological disorder (other than headaches or peripheral nerve disease) as these may impact neuroimaging results.
- Ferrous material implanted in or on the body, including flakes or filings, surgical clips, bullets, or electrical devices such as a pacemaker, or nonremovable ferrous jewelry (fillings in teeth and permanent retainers...
- Fillings and permanent retainers do not provide a safety risk and are not general exclusions. However, upper retainers may cause artifacts in ventral frontal regions and therefore may be an exclusion for some studies.
- Individuals with surgical pins or plates above the neck are excluded. Surgical pins or plates below the neck are exclusions, except when the material is fixed to bone, and considered acceptable by the Reference Manual...
- History of eye injury involving metallic materials, shavings in eyes, or welding without a face mask
- Lead/iron tattoos
- Claustrophobia (history of significant anxiety in closed places).
- Back problem that would prevent the subject from laying still comfortably for up to 90 minutes.
- Deafness
The study team makes the final eligibility decision.
Where it's taking place
- New Brunswick, New Jersey, United States
- Piscataway, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Brunswick, New Jersey, United States; Piscataway, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.