AzTrials
AzTrials

Type 2 Diabetes MellitusPhase 1/2GLUCIMAGNCT01493934

Development of a Fast Measurement Technique of Insulin Resistance in Human

A Phase 1/2 study testing injection of 6-DIG in people with Type 2 Diabetes Mellitus, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Insulin resistance, characterised by a depressed cellular sensitivity to insulin in insulin-sensitive organs, is a central feature of the metabolic syndrome. In people with no diabetes mellitus, the presence of metabolic syndrome leads to an increase of mortality, whatever the cause, but, as a majority, cardiovascular… Read more about this study

Who is it for?
Ages 35 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
injection of 6-DIG
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteFrance
Study dates
Apr 2010to Mar 2013
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy volunteers
  • Aged between 35 et 60 years old
  • Body mass index between 20 and 25
  • Waist measurement < 94 cm for men and < 80 cm for women
  • Normal basal glycemia, between 3,8 and 5,8 mmol/l
  • Normal basal insulinemia, between 3 and 13 μUI/ml
Show all 20Show fewer
  • HbA1c < 6%
  • Total cholesterol < 2 g/l
  • LDL cholesterol < 1,6 g/l
  • HDL cholesterol 0,4 g/l for men and 0,5 g/l for women
  • Triglyceride level < 1,5 g/l
  • For women not menopausal since at last one year or not surgically sterilised:
  • On-going contraception, physical or hormonal, excepted local methods (spermicidal, diaphragm, condom, cape)
  • Type 2 diabetic patients
  • Aged between 35 et 60 years old
  • Stable type 2 diabetes mellitus: no ketoacidosis sign during last month
  • HbA1c between 6 and 8% during the 3 months before study inclusion
  • Monotherapy by metformin or diet only
  • For women not menopausal since at last one year or not surgically sterilised:
  • On-going contraception, physical or hormonal, excepted local methods (spermicidal, diaphragm, condom, cape)

Who cannot join

  • Diabetes mellitus previously known
  • Other on-going progressive illness
  • Psychiatric illness, needing a chronic treatment
  • Previous history of myocardial infarction, coronary artery disease, cardiac rhythm troubles, stroke, epilepsy, cranial trauma, pituitary surgery, disease likely to reduce the ability of absorption, diffusion or excretion of the radiotracer.
  • Severe hypertension defined by par SAP > 180 mmHg and/or DAP > 110 mmHg
  • Allergy to one of the components of the products used during the study
Show all 26Show fewer
  • Nuclear medicine examination during the 30 days prior to study inclusion
  • Treatment likely to interfere with glucose metabolism
  • Alcohol or drug intoxication
  • Vegetarian or restrictive low-calory diet,
  • Pregnant, parturient or breast-feeding women,
  • Inappropriate way of life
  • Type 2 diabetic patients.
  • Previous history of myocardial infarction
  • Severe hypertension defined by par SAP > 180 mmHg and/or DAP > 110 mmHg
  • Previous history of coronary artery disease, cardiac rhythm troubles, stroke, epilepsy, cranial trauma, pituitary surgery, disease likely to reduce the ability of absorption, diffusion or excretion of the radiotracer.
  • Psychiatric illness, needing a chronic treatment
  • On-going insulin treatment
  • On-going treatment other than metformin, likely to interfere with glucose metabolism
  • Previous history of disease likely to reduce the ability of absorption, diffusion or excretion of the radiotracer
  • Allergy to one of the components of the products used during the study
  • Nuclear medicine examination during the 30 days prior to study inclusion
  • Alcohol or drug intoxication
  • Vegetarian or restrictive low-calory diet,
  • Pregnant, parturient or breast-feeding women,
  • Inappropriate way of life

Trial locations and contacts

1 site in 1 country.

France1 site

  • Service de Biophysique et Médecine Nucléaire, CHU de Grenoble

    Grenoble

Other trials in France

About this study

Official title: Development of a Fast Measurement Technique of Insulin Resistance in Human, With 123-6-deoxy-6 Iodo-D-glucose, a New Tracer of Glucose Transport

Insulin resistance, characterised by a depressed cellular sensitivity to insulin in insulin-sensitive organs, is a central feature of the metabolic syndrome. In people with no diabetes mellitus, the presence of metabolic syndrome leads to an increase of mortality, whatever the cause, but, as a majority, cardiovascular diseases.

In patients with type 2 diabetes mellitus, the presence of a metabolic syndrome leads to an increase in major adverse cardiovascular events. The prevalence of metabolic syndrome is led to grow in a near future, because of the increase of diabetes mellitus and obesity prevalence.

Read more

Actually, there is no simple tool to measure insulin resistance. The gold standard technique remains the hyperinsulinemic euglycemic clamp. However, the complexity and length of this technique render it unsuitable for routine clinical use. Many methods or index have been proposed to assess insulin resistance in human, but none have shown enough relevance to be used in clinical use.

Within the investigators U877 INSERM team, the investigators previously performed in vivo biodistribution studies with 6-DIG (6-deoxy-6-iodo-D-glucose), a new tracer of glucose transport, radiolabelled with123 iodine, with and without insulin, on the one hand in genetically diabetic mice (db/db), consequently having a severe insulin resistance and in the other hand in rats with acquired insulin resistance after a "fructose diet".

The investigators have demonstrated that 6-DIG is able to identify in vivo slight glucose transport variations in insulin sensible organs. Then, the investigators developed a fast and simple imaging protocol with a small animal gamma camera, which allows the obtaining of an insulin resistance index for each organ, directly transferable to human.

The investigators project is to transfer to human this measurement technique, perfectly validated in animal.

The main goal of this monocentric phase I-II study is to evaluate the tolerance to the insulin resistance measurement technique with 6DIG scintigraphy, in healthy volunteers and in diabetic patients. The investigators plan to enrol 6 healthy volunteers and 6 type 2 diabetic patients.

The investigators secondary goals will be to evaluate feasibility and reproducibility of the measurement technique, to follow pharmacokinetic and to assess efficacy of 6-DIG to measure insulin resistance.

Being tested
injection of 6-DIG
Keywords
metabolic syndrome, type 2 diabetes mellitus, insulin resistance, Scintigraphy
Medical subject headings
Diabetes Mellitus, Type 2, Metabolic Syndrome, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • injection of 6-DIGDrug

    Unique injection dose of 92.5 MBq

Study groups in NCT01493934
Study groupRoleWhat they receive
Healthy volunteersActive comparatorFirst injection in human, on 6 healthy volunteers, sequentially : volunteer number1, then volunteers n°2 to n° 6, before infusion in type 2 diabetic patients.
Receives: Drug: injection of 6-DIG
type 2 diabetic patientsExperimentalAfter completion of the study for the 6 healthy volunteers, infusion in 6 type 2 diabetic patients.
Receives: Drug: injection of 6-DIG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of glycemia

    Assessment of tolerance to insulin resistance measurement technique with 6-DIG scintigraphy, in healthy volunteers

    • clinical tolerance to 6-DIG infusion
    • clinical and biological tolerance to insulin infusion
    • evaluation of dosimetry

    Measured: Before inclusion in clinical trial, Before radiotracer injection, After radiotracer injection (time: 30s, 1', 2',5',10',15',25', 1 hour, 2 hours, 4 hours, 8 hours, 24 hours)

Secondary outcomes (4)

  1. insulinemia

    Measured: Before inclusion in clinical trial, Before radiotracer injection, After radiotracer injection (time: 30s, 1', 2',5',10',15',25', 1 hour, 2 hours, 4 hours, 8 hours, 24 hours)

  2. clinical side effects

    hypoglycemia symptoms

    Measured: Before inclusion in clinical trial, Before radiotracer injection, After radiotracer injection (time: 30s, 1', 2',5',10',15',25', 1 hour, 2 hours, 4 hours, 8 hours, 24 hours)

  3. dosimetry

    organs biodistribution of radioactivity

    Measured: during the 24 hours following injection of 6-DIG

  4. insulin resistance

    scintigraphic measurement of glucose transport in heart before and after infusion of insulin

    Measured: 0-15 minutes following 6-DIG infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2011 (estimated)
  2. Study startApr 2010
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01493934
Sponsor's protocol ID
C09-07
Other IDs
2009-014658-14, 2009
Acronym
GLUCIMAG
Status last verified
Feb 2016
First submitted
28 Apr 2010
Last updated
27 Aug 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Calizzano A, Perret P, Desruet MD, Ahmadi M, Reboulet G, Djaileb L, Vanzetto G, Fagret D, Barone-Rochette G, Ghezzi C. Safety, Biodistribution, and Dosimetry of 123I-6-Deoxy-6-Iodo-D-Glucose, a Tracer of Glucose Transport, in Healthy and Diabetic Volunteers. Clin Nucl Med. 2019 May;44(5):386-393. doi: 10.1097/RLU.0000000000002510.

    PubMed 30888989

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing injection of 6-DIG in people with Type 2 Diabetes Mellitus, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of glycemia (time frame: Before inclusion in clinical trial, Before radiotracer injection, After radiotracer injection (time: 30s, 1', 2',5',10',15',25', 1 hour, 2 hours, 4 hours, 8 hours, 24 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01493934, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in