Effect of Postprandial Insulin Administration of Faster-acting Insulin Analogue Versus Pre-prandial Administration of Acting-insulin Analogue in Cystic Fibrosis Related Diabetes

NCT04381429 | Terminated Phase 4

• 1 other identifier: 7546
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Cystic fibrosis related diabetes (CFRD) is a major factor of morbidity and mortality at all disease stages. Insulin deficiency has serious clinical consequences by increasing malnutrition, since protein and lipid catabolism is accelerated in chronic infections. Traditionally, insulin is injected before a meal. Yet, in these patients with highly varied and often staggered nutritional intakes, insulin injection can result in an increased risk of postprandial hypoglycaemia, all the more so as CF patients exhibit decreased glucagon secretion. Recent progress in the development of new insulins mimicking the physiological secretion more closely has led to ultra-fast insulins (fast aspart), allowing for postprandial hyperglycaemia to be better controlled. In Type 1 diabetics treated with basal-bolus, faster-acting aspart insulin injected after a meal enabled metabolic control comparable to injection of aspart insulin prior to the meal. Fast apart insulin is of particular interest with regard to CFRD, wherein postprandial hyperglycaemia occurs early. In CFRD, these insulins are likewise advantageous in that they can be injected after the meal, thus permitting more flexibility in patients with highly varied diets. Moreover, the insulin dose can be adapted depending on dietary intake, thus preventing hypoglycaemia secondary to highly-varied carbohydrate intakes. Due to its flexibility, this insulin therapy is likely to be better accepted by patients with cystic fibrosis.

Conditions

Cystic Fibrosis-related Diabetes

Outcome Measures

Primary Outcomes (1)

• Change of time in range of blood glucose variation (70-180 mg/dl) versus baseline at the end of each treatment period of 3 months (the last 2 weeks of the period of 3 months) is assessed.

  This measurement is assessed at the end of each treatment period of 3 months (the last 2 weeks of the period of 3 months). Month 3, month 6, month 9 and month 12.

Secondary Outcomes (14)

• Other CGM parameters: mean glucose value per day (mg/dl)

  screening(Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3(3 months after inclusion)-Month 6-Month 9-Month 12

• Other CGM parameters: glucose area under the curve for glucose value>180mg/dl - number of glucose values<70 mg/dl-number of glucose values<53mg/dl

  screening(Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3(3 months after inclusion)-Month 6-Month 9-Month 12

• Other CGM parameters: time in range of blood glucose >180, >140 <70mg/dl

  screening(Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3(3 months after inclusion)-Month 6-Month 9-Month 12

• Hypoglycaemic events experienced by the patient - number of symptomatic hypoglycaemic events under 70 mg/dl par mois - number of major hypoglycaemic events per year - number of nocturnal hypoglycaemic events per month

  Inclusion visit (Day0)-visit Month 3(3 months after inclusion visit)-Visit Month 6-Month 9-Month 12

• Markers of nutritional status: Body Mass Index (BMI)

  visit (Day 0 to 3 months to Day 0-Inclusion visit (Day 0)-visit Month 3 (3 months after inclusion visit)-Visit Month 6-Month 9-Month 12

Study Arms (2)

Group 1: A-F-A-F

ACTIVE COMPARATOR

The study is an open, randomized, two-treatment - 4 periods of 3 months - 2 group cross-over superiority study. All patients will test both insulin treatments (A and F) in alternating periods. The patients of group 1 will start with pre-prandial aspart insulin (NovoRapid). Each treatment period will last 3 months.

Drug: A-F-A-F (NovoRapid-FIASP-NovoRapid-FIASP)

Groupe 2: F-A-F-A

ACTIVE COMPARATOR

The study is an open, randomized, two-treatment - 4 periods of 3 months - 2 group cross-over superiority study. All patients will test both insulin treatments (A and F) in alternating periods. The patients of group 2 will start with post prandial Faster-acting aspart insulin (FIASP).

Drug: F-A-F-A (FIASP-NovoRapid-FIASP-NovoRapid)

Interventions

A-F-A-F (NovoRapid-FIASP-NovoRapid-FIASP) DRUG

A = pre-prandial aspart insulin (NovoRapid) F = post prandial Faster-acting aspart insulin (FIASP)

Also known as: All patients will have both treatments: NovoRapid + FIASP

Group 1: A-F-A-F

F-A-F-A (FIASP-NovoRapid-FIASP-NovoRapid) DRUG

A = pre-prandial aspart insulin (NovoRapid) F = post prandial Faster-acting aspart insulin (FIASP)

Also known as: All patients will have both treatments: NovoRapid + FIASP

Groupe 2: F-A-F-A

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with cystic fibrosis related diabetes aged over 10 years (no upper age limite)
• Patient treated by multiple insulin injections (minimal three insulin injections per day or basal bolus insulin regimen) or insulin pump
• Naive patient of Fiasp or patient under Fiasp, having carried out a run-in period of one month with rapid acting insulin treatment
• Affiliated to a social security scheme
• Subject able to understand the objectives and the risks related to the research and to give a dated and signed informed consent
• Subject having been informed of the results of the prior medical examination
• Written informed consent, dated and signed before initiating any trial-related procedure (if the subject is a minor, the consent must be signed by the 2 legal representative and the patient if he/she is able to give consent)

You may not qualify if:

• Patient with type 1 or type 2 diabetes
• Patient with cystic fibrosis related diabetes treated with 2 injections / day
• Patient with an HbA1C greater than 12% who demonstrate therapeutic non-compliance
• Patient pregnant (positive urinary pregnancy test) or wishing to pregnancy
• Contraindication to Aspart insulin
• Patient who cannot be followed during 12 months
• Impossibility of giving the subject enlightened information (subject in emergency situation, difficulties of understanding, cognitive impairment...)
• Subject under the protection of justice
• Subject under guardianship or curatorship

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Interventions

Insulin Aspart

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 8, 2020
• Study Start: August 17, 2020
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-02

Locations

FR (1)