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Insulin

Detemir for Obesity (IDIOM Trial)

N/A

Waitlist Available

Led By Kevin D Niswender, MD/PhD

Research Sponsored by Vanderbilt University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 26 weeks

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is evaluating the effects of insulin detemir on weight, brain function, and mood in people with obesity.

Who is the study for?

Adults aged 31-60 with stable obesity (BMI of 30-49), type 2 diabetes not on insulin, and a weight under 350lbs can join. They must have maintained their weight recently, be willing to follow diet plans, and avoid certain substances before visits. Those with significant health issues or conditions that affect study participation are excluded.

What is being tested?

The trial is testing if insulin detemir helps manage obesity when combined with a low-calorie diet compared to the diet alone. It will also look at effects on brain function, mood, heart disease risk factors through outpatient/inpatient visits involving questionnaires and scans over a period of 26 weeks.

What are the potential side effects?

Potential side effects may include changes in blood sugar levels due to insulin use which could lead to hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar), as well as possible discomfort from injections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 26 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~26 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Diabetes Mellitus, Non-Insulin-Dependent

Secondary study objectives

Neuropsychiatric functions

Side effects data

From 2017 Phase 4 trial • 157 Patients • NCT01966978

50%

18%

headache

16%

Other AE

Diabetic Ketoacidosis

Respiratory Distress

Pneumonia

Fall

nasopharyngeal carcinoma

myocardial infarction

Facial Burn

Urinary Tract Infection

Small Bowel Obstruction

Osteomyelitis

bacteremia

puncture wound

nephrotic syndrome

Lower GI bleed

100%

80%

60%

40%

20%

Study treatment Arm

Control: Metformin, Insulin Detemir, Insulin Aspart

Metformin, Insulin Determir, Liraglutide

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Insulin Detemir TreatmentExperimental Treatment1 Intervention

Insulin detemir treatment: Insulin detemir will be administered subcutaneously, once daily. Dose ranges from approximately 0.1 U/kg up to 0.6 u/kg or higher. The dosing regimen will employ a strategy similar to the "303"algorithm, where, with close interaction with study personnel (rather than self-titration), bedtime insulin dosing will be titrated up by 3 units until AM fasting sugars within the prescribed protocol range are achieved (90-110 mg/dl). Subjects will have contact with study personnel on weekly basis for glycemia monitoring and adjustments. Similarly, documented hypoglycemia (blood sugars less than 70) will trigger a dose reduction, and it is expected that with weight loss, tolerable insulin dosages will drift downward. The treatment period is 24 weeks.

Group II: Comparator: No insulinActive Control1 Intervention

The main hypothesis is that "diabetes can be changed " with early and careful insulinization capturing effects on brain function ultimately leading to weight loss. . Seek to determine in a quantitative manner whether insulin detemir restores brain dopamine neurotransmission, a control group not treated with insulin is required. The strength of this study is our ability to test the specific molecular (D2R, DAT, functional MRI responses) and integrated output (functional brain responses, mood, cognitive function, reward responses etc.) of CNS dopaminergic pathways in order to shed unprecedented light upon mechanisms of detemir action in obesity and diabetes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Insulin detemir

FDA approved

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