Early Diagnosis of Diabetes Mellitus in Patients With Cystic Fibrosis

NCT00662714 | Completed Phase 3

• 1 other identifier: F01/01 CF-RD
• Study Type: interventional
• Target: 73
• Locations: 4 countries
• Sites: 36

Brief 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.

Conditions

Cystic Fibrosis; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• HbA1c

  2 years

Study Arms (2)

1

EXPERIMENTAL

Repaglinide; oral

Drug: Repaglinide

2

ACTIVE COMPARATOR

short-acting Insulin (Actrapid)

Drug: short-acting Insulin (Actrapid)

Interventions

Repaglinide DRUG

oral; initial dose: 3x 0.5mg/d; 2 years

1

short-acting Insulin (Actrapid) DRUG

initial dose: 3x 0.05E/kg/d, injected; 2 years

Also known as: Actrapid

2

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:

• Diagnosed cystic fibrosis
• Age 10 years and older
• Newly diagnosed Diabetes mellitus in the screening

You may not qualify if:

• Diabetic keto-acidosis (blood glucose \> 350 mg/dl and arterial pH \< 7.25)
• Already treated Diabetes mellitus by oral antidiabetic medication or insulin
• 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

Sponsors & Collaborators

• Mukoviszidose Institut gGmbH: lead
• Novo Nordisk A/S: collaborator
• Mucoviscidose-ABCF2: collaborator
• Assistance Publique - Hôpitaux de Paris: collaborator

Study Sites (36)

Universitätsklinik für Kinder- und Jugendheilkunde

Graz, 8036, Austria

Location

Universitätsklinik für Kinder- und Jugendheilkunde

Vienna, 1090, Austria

Location

CRCM adultes

Lille, 59037, France

Location

CRCM adultes, Centre Hospitalier Lyon Sud

Lyon, 69495, France

Location

APHP, CRCM pediatrique, Hopital Necker

Paris, 75015, France

Location

APHP, CRCM pediatrique, Hopital Robert Debre

Paris, 75019, France

Location

APHP, CRCM pediatrique, Hopital Cochin

Paris, 75679, France

Location

CRCM adultes, Hopital Civil

Strasbourg, 67000, France

Location

Helios Klinikum Emil von Behring

Berlin, 12200, Germany

Location

Heliosklinikum Berlin-Buch

Berlin, 13125, Germany

Location

Prof.-Hess-Kinderklinik/ Zentralkrankenhaus

Bremen, 28205, Germany

Location

Zentralkrankenhaus "Links der Weser"

Bremen, 28277, Germany

Location

Klinik und Poliklinik für allgemeine Kinderheilkunde

Cologne, 50937, Germany

Location

Universitätskinderklinik Düsseldorf

Düsseldorf, 40225, Germany

Location

Klinik für Kinder und Jugendliche Erlangen

Erlangen, 91054, Germany

Location

Universitätsklinikum Essen

Essen, 45147, Germany

Location

Ruhrlandklinik Essen

Essen, 45239, Germany

Location

Zentrum für Kinderheilkunde Frankfurt

Frankfurt, 60590, Germany

Location

Med. Klinik II, Allergologie und Pneumologie

Frankfurt, 60596, Germany

Location

Klinik Schillerhöhe

Gerlingen, 70839, Germany

Location

Klinik und Poliklinik für Kinder- und Jugendmedizin

Greifswald, 17475, Germany

Location

Altona - Klinik

Hamburg, 22763, Germany

Location

Medizinische Hochschule Hannover, Abt. Kinderheilkunde

Hanover, 30625, Germany

Location

Medizinische Hochschule Hannover, CF-Ambulanz f. Erwachsene

Hanover, 30625, Germany

Location

Klikum der Universität Heidelberg, Kinderklinik

Heidelberg, 69120, Germany

Location

Universitätsklinik für Kinder- und Jugendmedizin

Homburg, 66421, Germany

Location

Kinderkrankenhaus Park Schönfeld

Kassel, 34121, Germany

Location

Städtisches Krankenhaus Kiel

Kiel, 24116, Germany

Location

Universitätsklinik Mainz

Mainz, 55101, Germany

Location

Clemenshospital

Münster, 48153, Germany

Location

Elisabeth Kinderkrankenhaus

Oldenburg, 26133, Germany

Location

Kinderhospital Osnabrück

Osnabrück, 49082, Germany

Location

Kinderklinik Dritter Orden, Sozialpädiatrisches Zentrum

Passau, 94032, Germany

Location

Universitätsklinik für Kinder- und Jugendmedizin

Tübingen, 72076, Germany

Location

Julius-Maximilians Universität, Kinderpoliklinik

Würzburg, 97080, Germany

Location

Centro Fibrosi Cistica

Verona, 37100, Italy

Location

Related Publications (4)

• Onady GM, Stolfi A. Drug treatments for managing cystic fibrosis-related diabetes. Cochrane Database Syst Rev. 2020 Oct 19;10(10):CD004730. doi: 10.1002/14651858.CD004730.pub5.

  PMID: 33075159 DERIVED

• Ballmann M, Hubert D, Assael BM, Staab D, Hebestreit A, Naehrlich L, Nickolay T, Prinz N, Holl RW; CFRD Study Group. Repaglinide versus insulin for newly diagnosed diabetes in patients with cystic fibrosis: a multicentre, open-label, randomised trial. Lancet Diabetes Endocrinol. 2018 Feb;6(2):114-121. doi: 10.1016/S2213-8587(17)30400-X. Epub 2017 Dec 5.

  PMID: 29199116 DERIVED

• Ballmann M, Hubert D, Assael BM, Kronfeld K, Honer M, Holl RW; CFRD Study group. Open randomised prospective comparative multi-centre intervention study of patients with cystic fibrosis and early diagnosed diabetes mellitus. BMC Pediatr. 2014 Mar 11;14:70. doi: 10.1186/1471-2431-14-70.

  PMID: 24620855 DERIVED

• Schmid K, Fink K, Holl RW, Hebestreit H, Ballmann M. Predictors for future cystic fibrosis-related diabetes by oral glucose tolerance test. J Cyst Fibros. 2014 Jan;13(1):80-5. doi: 10.1016/j.jcf.2013.06.001. Epub 2013 Jun 25.

  PMID: 23809507 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis; Diabetes Mellitus

Interventions

repaglinide; Insulin, Short-Acting; Insulin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Proinsulin

Study Officials

• Manfred Ballmann, Prof. Dr.

  St. Josef Hospital,Alexandrinenstrasse 5,44791 Bochum, Germany

  PRINCIPAL INVESTIGATOR

• Reinhard Holl, Prof.

  Zentralinstitut für Biomedizinische Technik Ulm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2008
• First Posted: April 21, 2008
• Study Start: September 1, 2001
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

IT (1); DE (27); AU (2); FR (6)