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

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Brief Title

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

Official Title

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

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.
    

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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Relative thickness as assessed by MRI

Secondary Outcome

 Relative thickness as assessed by MRI

Condition

Type 1 Diabetes

Intervention

Apidra

Study Arms / Comparison Groups

 Group 1
Description:  Daily use of insulin Apidra in insulin pump. The dosis will be according to the patient's former dosing scheme.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

14

Start Date

September 2016

Completion Date

April 2019

Primary Completion Date

April 2019

Eligibility Criteria

        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.
      

Gender

All

Ages

6 Years - 40 Years

Accepts Healthy Volunteers

No

Contacts

Olga Kordonouri, MD, , 



Administrative Informations


NCT ID

NCT02914886

Organization ID

IIT-14652


Responsible Party

Principal Investigator

Study Sponsor

Kinderkrankenhaus auf der Bult

Collaborators

 Sanofi

Study Sponsor

Olga Kordonouri, MD, Principal Investigator, Kinder- und Jugendkrankenhaus AUF DER BULT


Verification Date

October 2019