Cystic FibrosisPhase 3NCT00662714
Early Diagnosis of Diabetes Mellitus in Patients With Cystic Fibrosis
A Phase 3 study testing Repaglinide and short-acting Insulin (Actrapid) in people with Cystic Fibrosis and Diabetes Mellitus, run by Mukoviszidose Institut gGmbH at 36 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Cystic Fibrosis, Diabetes Mellitus
- What is being tested?
- Repaglinide and short-acting Insulin (Actrapid)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 36 sitesin 4 countries
- Study dates
- Sep 2001to Dec 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed cystic fibrosis
- Age 10 years and older
- Newly diagnosed Diabetes mellitus in the screening
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
36 sites in 4 countries.
36 sites in 4 countries
Germany27 sites
Helios Klinikum Emil von Behring
Berlin, 12200
Heliosklinikum Berlin-Buch
Berlin, 13125
Prof.-Hess-Kinderklinik/ Zentralkrankenhaus
Bremen, 28205
Zentralkrankenhaus "Links der Weser"
Bremen, 28277
Klinik und Poliklinik für allgemeine Kinderheilkunde
Cologne, 50937
Universitätskinderklinik Düsseldorf
Düsseldorf, 40225
Klinik für Kinder und Jugendliche Erlangen
Erlangen, 91054
Universitätsklinikum Essen
Essen, 45147
Ruhrlandklinik Essen
Essen, 45239
Zentrum für Kinderheilkunde Frankfurt
Frankfurt, 60590
Med. Klinik II, Allergologie und Pneumologie
Frankfurt, 60596
Klinik Schillerhöhe
Gerlingen, 70839
Klinik und Poliklinik für Kinder- und Jugendmedizin
Greifswald, 17475
Altona - Klinik
Hamburg, 22763
Medizinische Hochschule Hannover, Abt. Kinderheilkunde
Hanover, 30625
Medizinische Hochschule Hannover, CF-Ambulanz f. Erwachsene
Hanover, 30625
Klikum der Universität Heidelberg, Kinderklinik
Heidelberg, 69120
Universitätsklinik für Kinder- und Jugendmedizin
Homburg, 66421
Kinderkrankenhaus Park Schönfeld
Kassel, 34121
Städtisches Krankenhaus Kiel
Kiel, 24116
Universitätsklinik Mainz
Mainz, 55101
Clemenshospital
Münster, 48153
Elisabeth Kinderkrankenhaus
Oldenburg, 26133
Kinderhospital Osnabrück
Osnabrück, 49082
Kinderklinik Dritter Orden, Sozialpädiatrisches Zentrum
Passau, 94032
Universitätsklinik für Kinder- und Jugendmedizin
Tübingen, 72076
Julius-Maximilians Universität, Kinderpoliklinik
Würzburg, 97080
France6 sites
CRCM adultes
Lille, 59037
CRCM adultes, Centre Hospitalier Lyon Sud
Lyon, 69495
APHP, CRCM pediatrique, Hopital Necker
Paris, 75015
APHP, CRCM pediatrique, Hopital Robert Debre
Paris, 75019
APHP, CRCM pediatrique, Hopital Cochin
Paris, 75679
CRCM adultes, Hopital Civil
Strasbourg, 67000
Austria2 sites
Universitätsklinik für Kinder- und Jugendheilkunde
Graz, 8036
Universitätsklinik für Kinder- und Jugendheilkunde
Vienna, 1090
About this study
Official title: Open Randomised Prospective Comparative Multi-centre Intervention Study of Patients With Cystic Fibrosis and Early Diagnosed Diabetes Mellitus
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.
Read the 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).
- Conditions
- Cystic Fibrosis, Diabetes Mellitus
- Being tested
- Repaglinide, short-acting Insulin (Actrapid)
- Medical subject headings
- Cystic Fibrosis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RepaglinideDrug
oral; initial dose: 3x 0.5mg/d; 2 years
short-acting Insulin (Actrapid)Drug
Also called Actrapid
initial dose: 3x 0.05E/kg/d, injected; 2 years
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Repaglinide; oral Receives: Drug: Repaglinide |
| 2 | Active comparator | short-acting Insulin (Actrapid) Receives: Drug: short-acting Insulin (Actrapid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startSep 2001
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mukoviszidose Institut gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S, Mucoviscidose-ABCF2, Assistance Publique - Hôpitaux de Paris
- Responsible party
- Sponsor
- Investigators
- Manfred Ballmann, Prof. Dr., Principal investigator, St. Josef Hospital,Alexandrinenstrasse 5,44791 Bochum, GermanyReinhard Holl, Prof., Principal investigator, Zentralinstitut für Biomedizinische Technik Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662714
- Sponsor's protocol ID
- F01/01 CF-RD
- Status last verified
- Jul 2012
- First submitted
- 17 Apr 2008
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33075159Ballmann 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.
PubMed 29199116Ballmann 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.
PubMed 24620855Schmid 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.
PubMed 23809507
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Randomised Prospective Comparative Multi-centre Intervention Study of Patients With Cystic Fibrosis and Early Diagnosed Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00662714
- Acronym / sponsor ID
- F01/01 CF-RD
- Conditions
- Cystic Fibrosis, Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Mukoviszidose Institut gGmbHUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S, Mucoviscidose-ABCF2, Assistance Publique - Hôpitaux de Paris
- Study start
- Sep 2001
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RepaglinideRepaglinide; oral |
| 2 | Active comparator | Drug: short-acting Insulin (Actrapid)short-acting Insulin (Actrapid) |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed cystic fibrosis
- Age 10 years and older
- Newly diagnosed Diabetes mellitus in the screening
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repaglinideoral; initial dose: 3x 0.5mg/d; 2 years | Drug | 1 |
| short-acting Insulin (Actrapid)Also: Actrapidinitial dose: 3x 0.05E/kg/d, injected; 2 years | Drug | 2 |
Primary outcome
HbA1c
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
- Derived from this study: PubMed 33075159Onady 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.
- Derived from this study: PubMed 29199116Ballmann 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.
- Derived from this study: PubMed 24620855Ballmann 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.
- Derived from this study: PubMed 23809507Schmid 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.
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manfred Ballmann, Prof. Dr. principal investigator
St. Josef Hospital,Alexandrinenstrasse 5,44791 Bochum, Germany
Reinhard Holl, Prof. principal investigator
Zentralinstitut für Biomedizinische Technik Ulm
36 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Repaglinide and short-acting Insulin (Actrapid) in people with Cystic Fibrosis and Diabetes Mellitus, run by Mukoviszidose Institut gGmbH at 36 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Germany, France, Austria, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00662714, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2012.