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

Children's Hospital Auf der Bult

Status and phase

Completed

Phase 4

Conditions

Type 1 Diabetes

Lipoatrophy

Treatments

Drug: current insulin

Drug: Apidra

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02914886

IIT-14652

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

All

Ages

6 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

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.