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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

IDIOM Trial Summary

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

Eligible Conditions
  • Obesity
  • Diabetes

IDIOM Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Diabetes Mellitus, Non-Insulin-Dependent
Secondary outcome measures
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

IDIOM 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
703 Previous Clinical Trials
6,143,091 Total Patients Enrolled
34 Trials studying Obesity
6,980 Patients Enrolled for Obesity
Novo Nordisk A/SIndustry Sponsor
1,512 Previous Clinical Trials
2,387,789 Total Patients Enrolled
141 Trials studying Obesity
131,798 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

Frequently Asked Questions

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~17 spots leftby Apr 2025