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Type 1 DiabetesPhase 4LASNCT02914886

Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS)

A Phase 4 study testing Apidra and current insulin in people with Type 1 Diabetes and Lipoatrophy, run by Kinderkrankenhaus auf der Bult.

Completed

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

Official record
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Trial summary

The purpose of this study is to investigate whether a zinc-free insulin is an effective treatment option for lipoatrophy in patients with type 1 Diabetes (T1D) and insulin pump (CSII, continuous subcutaneous insulin infusion) therapy. Read more about this study

Who is it for?
Ages 6 to 40 years
Conditions the study is for
Type 1 Diabetes, Lipoatrophy
What is being tested?
Apidra and current insulin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
No sites listed yet
Study dates
Sep 2016to Apr 2019
Phase
Phase 4
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 6 to 40 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients with type 1 diabetes and documented lipoatrophy at injection sites on CSII treatment
  • Age between 6 and 40 years (both inclusive, see rationale for the inclusion of minors above)
  • Signed informed consent form from patients or from parents/their guardians if children/youths <18 years
  • Patients must be willing to undergo all study procedures

Who cannot join

  • Patients with previous use of insulin glulisine
  • Patients requiring corticosteroids as treatment medication. NOTE inhaled corticosteroids are allowed.
  • Patients suffering from severe chronic disease other than T1D or genetic disorder (i.e. Down syndrome etc.)
  • Pregnant or lactating women
  • Patients participating in other device or drug studies
  • History of drug or alcohol abuse within the last five years prior to screening
Show all 34Show fewer
  • Anamnestic history of hypersensitivity to the study drugs (or any component of the study drug) or to drugs with similar chemical structures
  • History of severe or multiple allergies
  • Treatment with any other investigational drug within 3 months prior to screening
  • Progressive fatal disease
  • History of significant cardiovascular (such as myocardial infarction, stroke, TIA), respiratory, gastrointestinal, hepatic (ALT and/or AST > 3 times the normal reference range), renal (creatinine > 1.1 mg/dl in women and > 1.5 mg/dl in men), neurological, psychiatric and/or hematological disease as judged by the investigator
  • Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomized partner
  • Lack of compliance or other similar reason that, according to investigator, precludes satisfactory participation in the study
  • Prisoners or subjects who are involuntarily incarcerated
  • Target Disease Exclusions
  • History of T2DM, maturity onset diabetes of young (MODY), pancreatic surgery or chronic pancreatitis
  • Any use of oral hypoglycemic agents within 12 months prior to the screening visit
  • History of diabetes ketoacidosis (DKA) within 12 weeks prior to the screening visit
  • History of hospital admission for glycemic control (either hyperglycemia or hypoglycemia) within 3 months prior to the screening visit
  • Frequent episodes of hypoglycemia as defined by more than one episode requiring assistance, emergency care (paramedics or emergency room care) or glucagon therapy, or more than 2 unexplained episodes of symptomatic hypoglycemia within 3 months prior to the screening visit. An unexplained event is defined as an event that cannot be explained by circumstances such as dietary (e.g. missed meal), strenuous exercise, error in insulin dosing, etc.
  • Hypoglycemic unawareness
  • History of diabetes insipidus
  • History of Addison's disease or chronic adrenal insufficiency
  • Physical and Laboratory Test Findings
  • BMI above 35 kg/m2
  • RR > 180/110 mm Hg
  • Aspartate aminotransferase (AST) > 3X Upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) > 3X ULN
  • Serum total bilirubin > 3X ULN
  • Estimated GFR (eGFR) < 60 ml/min/1.73 m2
  • Hemoglobin ≤ 11.0 g/dl (110 g/l) for boys / men; hemoglobin ≤10.0 g/dl (100 g/L) for girls / women.
  • Creatine kinase (CK) > 3X ULN
  • Positive for hepatitis B surface antigen or anti-hepatitis C virus antibody.
  • Abnormal Free T4 Note: abnormal TSH value at screening will be further evaluated for free T4. Subjects with abnormal free T4 values will be excluded. A one-time retest may be allowed, as determined by the Investigator, after a minimum of 6 weeks following the adjustment of thyroid hormone replacement therapy in subject who have had a prior diagnosis of a thyroid disorder and who are currently receiving thyroid replacement therapy. Such cases should be discussed with the Investigator prior to retesting.

About this study

Official title: Lipoatrophy in Children, Adolescents and Adults With Modern Treatment Modalities: is There a Beneficial Effect of Insulin Glulisine?

The purpose of this study is to investigate whether a zinc-free insulin is an effective treatment option for lipoatrophy in patients with type 1 Diabetes (T1D) and insulin pump (CSII, continuous subcutaneous insulin infusion) therapy.

Read the detailed description

Randomized, controlled, open-label parallel study. Clinical Study Phase IV After being included in the study, subjects are getting an extensive dermatological examination by a pediatric dermatologist familiar with cutaneous complications of T1D, additionally pathological results will be documented by photography and, if necessary, videodermoscopy. Additionally, an evaluation of their lipoatrophic areas using imaging methods like ultrasound (USG) and MRI will be performed. After randomization, half of the included children switch their pump insulin into insulin glulisine (intervention group) for 6 months. The others continue their current treatment (control group) and switch to insulin glulisine 6 months later. Both groups are followed-up until month 12. Hence, after the 4th visit at 6 months, all enrolled patients are on insulin glulisine pumps for a further period of 6 months.

Being tested
Apidra, current insulin
Keywords
Diabetes, Lipoatrophy, children, adolescents, adults, insulin therapy
Medical subject headings
Diabetes Mellitus, Type 1, Lipodystrophy, Diabetes Mellitus

What participants receive

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

  • ApidraDrug

    Also called Glulisine

    Half of patients with lipoatrophy will be switched randomly to insulin Apidra for 12 months. Any site other than the lipoatrophic site would be used for delivering the insulin for the purpose of this study.

  • current insulinDrug

    Also called short-acting analog insulin

    Half of patients with lipoatrophy will still use their current Insulin for 6 months. After 6 months the current insulin will be switched to insulin Apidra for the next 6 months.

Study groups in NCT02914886
Study groupRoleWhat they receive
Group 1ExperimentalDaily use of insulin Apidra in insulin pump. The dosis will be according to the patient's former dosing scheme.
Receives: Drug: Apidra
Group 2Active comparatorDaily use of current insulin in insulin pump.The dosis will be according to the patient's former dosing scheme.
Receives: Drug: current insulin

What is being measured

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

  1. Relative thickness as assessed by MRI

    The relative thickness will be used instead of raw data of the MRI measurements as given by the thickness of the most atrophic region related to the thickness of the reference region of the same patient (normal tissue). The change (increase) of the thickness is defined as difference between the relative thicknesses of the same atrophic region (given as percentage of the same reference region) at 6 months and study begin.

    Measured: at 6 months

Secondary outcomes (11)

  1. Relative thickness as assessed by MRI

    Change of relative thickness (as defined above) at 6 and 12 months in the control group

    Measured: at 6 and 12 months

  2. Relative thickness as assessed by MRI

    Change of relative thickness (as defined above) between baseline and 12 months in both arms

    Measured: at baseline and 12 months

  3. Relative thickness as assessed by USG

    The relative thickness will be used as given by the thickness of the most atrophic region related to the thickness of the reference region of the same patient (normal tissue). The change (increase) of the thickness is defined as difference between the relative thicknesses of the same atrophic region (given as percentage of the same reference region) at 6 months between both groups

    Measured: at 6 months

  4. Relative thickness as assessed by USG

    The relative thickness will be used as given by the thickness of the most atrophic region related to the thickness of the reference region of the same patient (normal tissue). The change (increase) of the thickness is defined as difference between the relative thicknesses of the same atrophic region (given as percentage of the same reference region) at 6 months and 12 months in the control group

    Measured: at 6 and 12 months

  5. Relative thickness as assessed by USG

    The relative thickness will be used as given by the thickness of the most atrophic region related to the thickness of the reference region of the same patient (normal tissue). The change (increase) of the thickness is defined as difference between the relative thicknesses of the same atrophic region (given as percentage of the same reference region) between baseline and 12 months in both groups

    Measured: at baseline and 12 months

  6. indicator dermatoses of Diabetes mellitus and associated autoimmune disorders of the skin

    Comparison of dermatological findings between 6 and 12 months in the control Group. Dermatological outcome measures will consist in the detection and documentation of a) indicator dermatoses of diabetes mellitus (e. g. lipoatrophy, necrobiosis lipoidica, granuloma anulare), b) associated autoimmune disorders of the skin (e. g. vitiligo, lichen sclerosus, lichen ruber) and c) other, concurrent skin disorders such as atopic dermatitis, acne or psoriasis, for example. If available, disease scores such as the SCORAD score for atopic dermatitis or the PASI score for psoriasis vulgaris will be used to document disease activity.

    Measured: at 6 and 12 months

  7. Number of new lipoatrophic areas

    Occurrence of new lipoatrophic areas in both arms at 6 and 12 months

    Measured: at 6 and 12 months

  8. Glycemic control

    Change of HbA1c at 6 and 12 months compared to baseline in both groups

    Measured: at 6 and 12 months

  9. Insulin requirements

    Change of total daily insulin units per kg body weight at 6 and 12 months compared to baseline in both groups

    Measured: at 6 and 12 months

  10. Laboratory findings

    Comparison of laboratory parameters (insulin antibodies, total IgE, specific insulin-IgE) between baseline, 6 months and 12 months

    Measured: at baseline, 6 months and 12 months

  11. Side effects

    Side-effects of treatment with other insulins and insulin glulisine such as

    • severe hypoglycemia
    • DKA
    • Catheter occlusion
    • SAEs

    Measured: within 12 months

Timeline

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

  1. First posted26 Sep 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionApr 2019
  4. Study completionApr 2019

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02914886
Sponsor's protocol ID
IIT-14652
Acronym
LAS
Status last verified
Oct 2024
First submitted
8 Jul 2016
Last updated
15 Oct 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Kordonouri O, Biester T, Weidemann J, Ott H, Remus K, Grothaus J, Pisarek N, Hartmann R, Adolph K, Lange K, Danne T. Lipoatrophy in children, adolescents and adults with insulin pump treatment: Is there a beneficial effect of insulin glulisine? Pediatr Diabetes. 2020 Nov;21(7):1285-1291. doi: 10.1111/pedi.13094. Epub 2020 Aug 19.

    PubMed 32738019

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Apidra and current insulin in people with Type 1 Diabetes and Lipoatrophy, run by Kinderkrankenhaus auf der Bult.

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 4 inclusion and 34 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 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Relative thickness as assessed by MRI (time frame: at 6 months). 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 NCT02914886, 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 15 Oct 2024.

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