Early Diagnosis of Diabetes Mellitus in Patients With Cystic Fibrosis

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Is oral therapy with Repaglinide equivalent to insulin therapy with three daily injections with respect to blood glucose control, weight and pulmonary function over 2 years in patients with cystic fibrosis and secondary diabetes mellitus? That is the question examined in the phase III trial.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mukoviszidose Institut gGmbH
• Collaborators: Assistance Publique - Hôpitaux de Paris; Mucoviscidose-ABCF2; Novo Nordisk A/S
• Treatments: Insulin; Insulin, Globin Zinc; Insulin, Short-Acting; Repaglinide

Criteria

Inclusion Criteria:

Inclusion Criteria for the Screening:

• Diagnosed cystic fibrosis

• Age 10 years and older

Inclusion Criteria for the therapeutic part of the study:

• Newly diagnosed Diabetes mellitus in the screening

Exclusion Criteria:

Exclusion Criteria for Screening:

• Diabetic keto-acidosis (blood glucose > 350 mg/dl and arterial pH < 7.25)

• Already treated Diabetes mellitus by oral antidiabetic medication or insulin

Exclusion Criteria for the therapeutic part of the study:

• Systemic steroid therapy during the last 3 months

• Transplantation (status post TX or on the waiting list for TX)

• Beginning pulmonary insufficiency, FEV1 < 35% at pulmonary function test in stable condition

• Pregnancy

• Already diagnosed and treated diabetes mellitus

• Patients with diabetic keto-acidosis (blood glucose > 350 mg/dl and arterial pH < 7.25) with or without diabetic coma

• Severe liver insufficiency (chronic hepatitis B, AST or ALT twice the upper limit of normal, Quick's value < 70% which is a contraindication to use Repaglinide)

• Treatment with an indispensable important drug which contraindicates Repaglinide

• PEG/ gastric tube/ total parenteral alimentation for more than 4 weeks during the study

• CF-patients with type 1 diabetes

• Not patient's consent to randomisation and therapeutic trial

• Participation on other medical trial