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

NCT02914886 | Completed Phase 4 DMC

• 1 other identifier: IIT-14652
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Type 1 Diabetes; Lipoatrophy

Keywords

Diabetes; Lipoatrophy; children; adolescents; adults; insulin therapy

Outcome Measures

Primary Outcomes (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.

  at 6 months

Secondary Outcomes (11)

• Relative thickness as assessed by MRI

  at 6 and 12 months

• Relative thickness as assessed by MRI

  at baseline and 12 months

• Relative thickness as assessed by USG

  at 6 months

• Relative thickness as assessed by USG

  at 6 and 12 months

• Relative thickness as assessed by USG

  at baseline and 12 months

Study Arms (2)

Group 1

EXPERIMENTAL

Daily use of insulin Apidra in insulin pump. The dosis will be according to the patient's former dosing scheme.

Drug: Apidra

Group 2

ACTIVE COMPARATOR

Daily use of current insulin in insulin pump.The dosis will be according to the patient's former dosing scheme.

Drug: current insulin

Interventions

Apidra DRUG

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.

Also known as: Glulisine

Group 1

current insulin DRUG

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.

Also known as: short-acting analog insulin

Group 2

Eligibility Criteria

• Age: 6 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with type 1 diabetes and documented lipoatrophy at injection sites on CSII treatment
• 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

You may not qualify if:

• 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
• 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
• History of T2DM, maturity onset diabetes of young (MODY), pancreatic surgery or chronic pancreatitis

Sponsors & Collaborators

• Kinderkrankenhaus auf der Bult: lead
• Sanofi: collaborator

Related Publications (1)

• 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.

  PMID: 32738019 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Lipodystrophy; Diabetes Mellitus

Interventions

insulin glulisine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders

Study Officials

• Olga Kordonouri, MD

  Kinder- und Jugendkrankenhaus AUF DER BULT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. (MD)

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: September 26, 2016
• Study Start: September 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share