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Early Diagnosis of Diabetes Mellitus in Patients With Cystic Fibrosis

Primary Purpose

Cystic Fibrosis, Diabetes Mellitus

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Repaglinide

short-acting Insulin (Actrapid)

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Repaglinide; oral

short-acting Insulin (Actrapid)

Outcomes

Primary Outcome Measures

HbA1c

Secondary Outcome Measures

Full Information

NCT ID

NCT00662714

First Posted

April 17, 2008

Last Updated

July 6, 2012

Sponsor

Mukoviszidose Institut gGmbH

Collaborators

Novo Nordisk A/S, Mucoviscidose-ABCF2, Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT00662714

Brief Title

Early Diagnosis of Diabetes Mellitus in Patients With Cystic Fibrosis

Official Title

Open Randomised Prospective Comparative Multi-centre Intervention Study of Patients With Cystic Fibrosis and Early Diagnosed Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

September 2001 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mukoviszidose Institut gGmbH

Collaborators

Novo Nordisk A/S, Mucoviscidose-ABCF2, Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Diabetes mellitus may be present in patients with cystic fibrosis (mucoviscidosis) starting in the second decade of life. The prevalence increases rapidly with increasing age. As life-expectancy increases in CF, CF-related diabetes will be diagnosed more frequently in the future. Negative consequences of secondary diabetes in cystic fibrosis include: Catabolic metabolism Weight loss More frequent / more severe infections Deterioration of pulmonary function Reduced life-expectancy Diabetic micro vascular complications (retinopathy, nephropathy, neuropathy) Up to date, no data are available to answer the question, whether secondary diabetes in CF should always be treated by insulin therapy. Several centres report the successful management of CF-related diabetes using oral anti-diabetic drugs at least for some years. Oral therapies would be less invasive for a patient group which is highly traumatised by a very demanding therapy (multiple drugs including antibiotics, pancreas enzymes, bronchodilators, mucolysis, in addition to physiotherapy, regular inpatient iv-antibiotic therapy etc, finally lung transplants in a subgroup of patients).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis, Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

73 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Repaglinide; oral

Arm Title

Arm Type

Active Comparator

Arm Description

short-acting Insulin (Actrapid)

Intervention Type

Drug

Intervention Name(s)

Repaglinide

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

short-acting Insulin (Actrapid)

Other Intervention Name(s)

Actrapid

Intervention Description

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

Primary Outcome Measure Information:

Title

HbA1c

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Manfred Ballmann, Prof. Dr.

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Reinhard Holl, Prof.

Organizational Affiliation

Zentralinstitut für Biomedizinische Technik Ulm

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universitätsklinik für Kinder- und Jugendheilkunde

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Universitätsklinik für Kinder- und Jugendheilkunde

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

CRCM adultes

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

CRCM adultes, Centre Hospitalier Lyon Sud

City

Lyon

ZIP/Postal Code

69495

Country

France

Facility Name

APHP, CRCM pediatrique, Hopital Necker

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

APHP, CRCM pediatrique, Hopital Robert Debre

City

Paris

ZIP/Postal Code

75019

Country

France

Facility Name

APHP, CRCM pediatrique, Hopital Cochin

City

Paris

ZIP/Postal Code

75679

Country

France

Facility Name

CRCM adultes, Hopital Civil

City

Strasbourg

ZIP/Postal Code

67000

Country

France

Facility Name

Helios Klinikum Emil von Behring

City

Berlin

ZIP/Postal Code

12200

Country

Germany

Facility Name

Heliosklinikum Berlin-Buch

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

Prof.-Hess-Kinderklinik/ Zentralkrankenhaus

City

Bremen

ZIP/Postal Code

28205

Country

Germany

Facility Name

Zentralkrankenhaus "Links der Weser"

City

Bremen

ZIP/Postal Code

28277

Country

Germany

Facility Name

Universitätskinderklinik Düsseldorf

City

Düsseldorf

ZIP/Postal Code

40225

Country

Germany

Facility Name

Klinik für Kinder und Jugendliche Erlangen

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Universitätsklinikum Essen

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Ruhrlandklinik Essen

City

Essen

ZIP/Postal Code

45239

Country

Germany

Facility Name

Zentrum für Kinderheilkunde Frankfurt

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Med. Klinik II, Allergologie und Pneumologie

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

Klinik Schillerhöhe

City

Gerlingen

ZIP/Postal Code

70839

Country

Germany

Facility Name

Klinik und Poliklinik für Kinder- und Jugendmedizin

City

Greifswald

ZIP/Postal Code

17475

Country

Germany

Facility Name

Altona - Klinik

City

Hamburg

ZIP/Postal Code

22763

Country

Germany

Facility Name

Medizinische Hochschule Hannover, Abt. Kinderheilkunde

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Medizinische Hochschule Hannover, CF-Ambulanz f. Erwachsene

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Klikum der Universität Heidelberg, Kinderklinik

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Universitätsklinik für Kinder- und Jugendmedizin

City

Homburg

ZIP/Postal Code

66421

Country

Germany

Facility Name

Kinderkrankenhaus Park Schönfeld

City

Kassel

ZIP/Postal Code

34121

Country

Germany

Facility Name

Städtisches Krankenhaus Kiel

City

Kiel

ZIP/Postal Code

24116

Country

Germany

Facility Name

Klinik und Poliklinik für allgemeine Kinderheilkunde

City

Köln

ZIP/Postal Code

50937

Country

Germany

Facility Name

Universitätsklinik Mainz

City

Mainz

ZIP/Postal Code

55101

Country

Germany

Facility Name

Clemenshospital

City

Münster

ZIP/Postal Code

48153

Country

Germany

Facility Name

Elisabeth Kinderkrankenhaus

City

Oldenburg

ZIP/Postal Code

26133

Country

Germany

Facility Name

Kinderhospital Osnabrück

City

Osnabrück

ZIP/Postal Code

49082

Country

Germany

Facility Name

Kinderklinik Dritter Orden, Sozialpädiatrisches Zentrum

City

Passau

ZIP/Postal Code

94032

Country

Germany

Facility Name

Universitätsklinik für Kinder- und Jugendmedizin

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Julius-Maximilians Universität, Kinderpoliklinik

City

Würzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Centro Fibrosi Cistica

City

Verona

ZIP/Postal Code

37100

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

33075159

Citation

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.

Results Reference

derived

PubMed Identifier

29199116

Citation

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. Erratum In: Lancet Diabetes Endocrinol. 2019 Apr;7(4):e4.

Results Reference

derived

PubMed Identifier

24620855

Citation

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.

Results Reference

derived

PubMed Identifier

23809507

Citation

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.

Results Reference

derived

Learn more about this trial

Early Diagnosis of Diabetes Mellitus in Patients With Cystic Fibrosis

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Early Diagnosis of Diabetes Mellitus in Patients With Cystic Fibrosis

Cystic Fibrosis, Diabetes Mellitus

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial