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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 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%
GI
18%
headache
16%
Other AE
7%
Diabetic Ketoacidosis
4%
Respiratory Distress
4%
Pneumonia
4%
Fall
2%
nasopharyngeal carcinoma
2%
myocardial infarction
2%
Facial Burn
2%
Urinary Tract Infection
2%
Small Bowel Obstruction
2%
Osteomyelitis
2%
bacteremia
2%
puncture wound
2%
nephrotic syndrome
2%
Lower GI bleed
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

Vanderbilt UniversityLead Sponsor
710 Previous Clinical Trials
6,143,139 Total Patients Enrolled
35 Trials studying Obesity
7,010 Patients Enrolled for Obesity
Novo Nordisk A/SIndustry Sponsor
1,552 Previous Clinical Trials
2,444,820 Total Patients Enrolled
153 Trials studying Obesity
143,551 Patients Enrolled for Obesity
Kevin D Niswender, MD/PhDPrincipal InvestigatorVanderbilt University

Media Library

Detemir (Insulin) Clinical Trial Eligibility Overview. Trial Name: NCT01239550 — N/A
Obesity Research Study Groups: Insulin Detemir Treatment, Comparator: No insulin
Obesity Clinical Trial 2023: Detemir Highlights & Side Effects. Trial Name: NCT01239550 — N/A
Detemir (Insulin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01239550 — N/A
~16 spots leftby Dec 2025
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