Cystic FibrosisPhase 3NCT00687466
Study on the Efficacy of Slow Release Insulin in Cystic Fibrosis Patients With Glucide Intolerance and Clinical Decay
A Phase 3 study testing Insulin in people with Cystic Fibrosis and Glucose Intolerance, run by Fondazione per la ricerca sulla Fibrosi Cistica at 6 sites in Italy.
Trial summary
The purpose of this study is to evaluate whether the anticipated use of glargine in CF patients with glucose intolerance may prevent the worsening of nutritional status and pulmonary function. Read more about this study
- Who is it for?
- Ages 10 to 70 years
- Conditions the study is for
- Cystic Fibrosis, Glucose Intolerance
- What is being tested?
- Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 6 sitesItaly
- Study dates
- Aug 2005to Oct 2009
- 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 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ascertained diagnosis of CF
- Age ≥ 10 years
- Glucide intolerance: 2 pathologic OGTT ( at 120' glucose value: >140 mg% and <200 mg%) at 2-6 months' interval between each other
- At least one of the following conditions:
- BMI (body mass index) < 10th centile for age and sex (according to Rolland Cachera 1991)
- Loss of one BMI centile class for age and sex in the last year (according to Rolland Cachera 1991)
- FEV1 ≤ 80% of predicted
- FEV1 decrease ≥ 10% in the last year
Who cannot join
- Specific contraindications for the use of glargine
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Pediatric Department, General Hospital,CF Center
Cerignola (Foggia)
Ospedale Maggiore Policlinico, Adult CF Center
Milan
Pediatric Department, Federico II University, Pediatric CF Center
Naples
Pediatric Department G.De Cristina Hospital CF Center
Palermo
Bambino Gesù Hospital CF Center
Roma
Policlinico Umberto I. CF Center
Roma
About this study
Official title: Phase 3 Study on the Efficacy of Slow Release Insulin in Cystic Fibrosis Patients With Glucide Intolerance and Clinical Decay
The purpose of this study is to evaluate whether the anticipated use of glargine in CF patients with glucose intolerance may prevent the worsening of nutritional status and pulmonary function.
Read the detailed description
Diabetes mellitus may often complicate the cystic fibrosis course, and it is usually preceded by a condition defined as glucose intolerance, during which a significant decay of patient's general conditions is observed. A slow release insulin (glargine) has become available in the market for diabetic patients: its characteristics allow for a single daily dose, and no need of repeated daily monitoring of glycemia.
In this randomized controlled clinical trial we evaluate whether the anticipated use of glargine in CF patients with glucose intolerance may prevent the worsening of nutritional status and pulmonary function.
Eligible patients who will accept to participate to this study will be randomly allocated in the group who will or will not receive glargine as additional supportive therapy. Patients will in any case continue the CF therapy prescribed by their treating physicians and their usual diet. All the patients will be evaluated every three months to assess their nutritional, pulmonary and glycometabolic status. The follow-up will continue until the 18th month after the study entry.
- Conditions
- Cystic Fibrosis, Glucose Intolerance
- Being tested
- Insulin
- Keywords
- Cystic Fibrosis, Glucose Intolerance
- Medical subject headings
- Cystic Fibrosis, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Also called Lantus
Insulin Glargine will be administered subcutaneously at the dosage of 0.1 U/Kg/die for three months. In case no hypoglycemic episodes occur during this period, the dosage will be increased to 0.15 U/Kg/die in occasion of the first control (T1) and will be scheduled for other three months. If even during this latter period no cases no hypoglycemic episodes occur, at the second control (T2) the dosage will be increased to the maximum of 0.2/U/Kg/die. It is generally accepted that the final dosage of glargine can be tailored to each patient, but it should be maintained between 0.1 and 0.2 U/Kg/die.
Glargine should be administered once daily in the morning and always at the same hour.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Insulin yes Receives: Drug: Insulin |
| 2 | No intervention | Insulin no |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status evaluated as variations of Z score of BMI
Measured: At recruitment time and at +3, +6, +9, +12, +15, +18 months
Secondary outcomes (1)
Glucose tolerance improvement evaluated as improvement of glycometabolic parameter (glycosylated Hb)
Measured: At time recruitment and +3,+6,+9+12+15+18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
- Study startAug 2005
- Primary completionOct 2009 (estimated)
- Study completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione per la ricerca sulla Fibrosi Cistica
- Sponsor type
- University, hospital or other
- Investigators
- Laura Minicucci, MD, Principal investigator, G.Gaslini Institute Pediatric Department CF Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687466
- Sponsor's protocol ID
- FFC #21/2006
- Other IDs
- eudraCT number 2005-002135-27, IGG-FC-G-01
- Status last verified
- Aug 2009
- First submitted
- 27 May 2008
- Last updated
- 4 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moran A, Hardin D, Rodman D, Allen HF, Beall RJ, Borowitz D, Brunzell C, Campbell PW 3rd, Chesrown SE, Duchow C, Fink RJ, Fitzsimmons SC, Hamilton N, Hirsch I, Howenstine MS, Klein DJ, Madhun Z, Pencharz PB, Quittner AL, Robbins MK, Schindler T, Schissel K, Schwarzenberg SJ, Stallings VA, Zipf WB, et al. Diagnosis, screening and management of cystic fibrosis related diabetes mellitus: a consensus conference report. Diabetes Res Clin Pract. 1999 Aug;45(1):61-73. doi: 10.1016/s0168-8227(99)00058-3. No abstract available.
PubMed 10499886Mackie AD, Thornton SJ, Edenborough FP. Cystic fibrosis-related diabetes. Diabet Med. 2003 Jun;20(6):425-36. doi: 10.1046/j.1464-5491.2003.00924.x.
PubMed 12786675Solomon MP, Wilson DC, Corey M, Kalnins D, Zielenski J, Tsui LC, Pencharz P, Durie P, Sweezey NB. Glucose intolerance in children with cystic fibrosis. J Pediatr. 2003 Feb;142(2):128-32. doi: 10.1067/mpd.2003.5.
PubMed 12584532Lanng S, Thorsteinsson B, Nerup J, Koch C. Influence of the development of diabetes mellitus on clinical status in patients with cystic fibrosis. Eur J Pediatr. 1992 Sep;151(9):684-7. doi: 10.1007/BF01957574.
PubMed 1396931Milla CE, Warwick WJ, Moran A. Trends in pulmonary function in patients with cystic fibrosis correlate with the degree of glucose intolerance at baseline. Am J Respir Crit Care Med. 2000 Sep;162(3 Pt 1):891-5. doi: 10.1164/ajrccm.162.3.9904075.
PubMed 10988101Dobson L, Hattersley AT, Tiley S, Elworthy S, Oades PJ, Sheldon CD. Clinical improvement in cystic fibrosis with early insulin treatment. Arch Dis Child. 2002 Nov;87(5):430-1. doi: 10.1136/adc.87.5.430. No abstract available.
PubMed 12390923Rafii M, Chapman K, Stewart C, Kelly E, Hanna A, Wilson DC, Tullis E, Pencharz PB. Changes in response to insulin and the effects of varying glucose tolerance on whole-body protein metabolism in patients with cystic fibrosis. Am J Clin Nutr. 2005 Feb;81(2):421-6. doi: 10.1093/ajcn.81.2.421.
PubMed 15699230Rolon MA, Benali K, Munck A, Navarro J, Clement A, Tubiana-Rufi N, Czernichow P, Polak M. Cystic fibrosis-related diabetes mellitus: clinical impact of prediabetes and effects of insulin therapy. Acta Paediatr. 2001 Aug;90(8):860-7.
PubMed 11529531Nousia-Arvanitakis S, Galli-Tsinopoulou A, Karamouzis M. Insulin improves clinical status of patients with cystic-fibrosis-related diabetes mellitus. Acta Paediatr. 2001 May;90(5):515-9.
PubMed 11430710Dobson L, Sheldon CD, Hattersley AT. Conventional measures underestimate glycaemia in cystic fibrosis patients. Diabet Med. 2004 Jul;21(7):691-6. doi: 10.1111/j.1464-5491.2004.01219.x.
PubMed 15209760Lombardo F, De Luca F, Rosano M, Sferlazzas C, Lucanto C, Arrigo T, Messina MF, Crisafulli G, Wasniewska M, Valenzise M, Cucinotta D. Natural history of glucose tolerance, beta-cell function and peripheral insulin sensitivity in cystic fibrosis patients with fasting euglycemia. Eur J Endocrinol. 2003 Jul;149(1):53-9. doi: 10.1530/eje.0.1490053.
PubMed 12824866Bizzarri C, Lucidi V, Ciampalini P, Bella S, Russo B, Cappa M. Clinical effects of early treatment with insulin glargine in patients with cystic fibrosis and impaired glucose tolerance. J Endocrinol Invest. 2006 Mar;29(3):RC1-4. doi: 10.1007/BF03345538.
PubMed 16682829Bismuth E, Laborde K, Taupin P, Velho G, Ribault V, Jennane F, Grasset E, Sermet I, de Blic J, Lenoir G, Robert JJ. Glucose tolerance and insulin secretion, morbidity, and death in patients with cystic fibrosis. J Pediatr. 2008 Apr;152(4):540-5, 545.e1. doi: 10.1016/j.jpeds.2007.09.025. Epub 2007 Nov 26.
PubMed 18346512
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study on the Efficacy of Slow Release Insulin in Cystic Fibrosis Patients With Glucide Intolerance and Clinical Decay
- ClinicalTrials.gov ID
- NCT00687466
- Acronym / sponsor ID
- FFC #21/2006
- Conditions
- Cystic Fibrosis, Glucose Intolerance
- Keywords
- Cystic Fibrosis, Glucose Intolerance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Fondazione per la ricerca sulla Fibrosi CisticaUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Oct 2009 (estimated)
- First posted
- 30 May 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.
The purpose of this study is to evaluate whether the anticipated use of glargine in CF patients with glucose intolerance may prevent the worsening of nutritional status and pulmonary function.
Detailed description
Diabetes mellitus may often complicate the cystic fibrosis course, and it is usually preceded by a condition defined as glucose intolerance, during which a significant decay of patient's general conditions is observed. A slow release insulin (glargine) has become available in the market for diabetic patients: its characteristics allow for a single daily dose, and no need of repeated daily monitoring of glycemia.
In this randomized controlled clinical trial we evaluate whether the anticipated use of glargine in CF patients with glucose intolerance may prevent the worsening of nutritional status and pulmonary function.
Eligible patients who will accept to participate to this study will be randomly allocated in the group who will or will not receive glargine as additional supportive therapy. Patients will in any case continue the CF therapy prescribed by their treating physicians and their usual diet. All the patients will be evaluated every three months to assess their nutritional, pulmonary and glycometabolic status. The follow-up will continue until the 18th month after the study entry.
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: InsulinInsulin yes |
| 2 | No intervention | –Insulin no |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Ascertained diagnosis of CF
- Age ≥ 10 years
- Glucide intolerance: 2 pathologic OGTT ( at 120' glucose value: >140 mg% and <200 mg%) at 2-6 months' interval between each other
- At least one of the following conditions:
Key exclusion criteria (1 listed)
- Specific contraindications for the use of glargine
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 |
|---|---|---|
| InsulinAlso: LantusInsulin Glargine will be administered subcutaneously at the dosage of 0.1 U/Kg/die for three months. In case no hypoglycemic episodes occur during this period, the dosage will be increased to 0.15 U/Kg/die in occasion of the first control (T1) and will be scheduled for other three months. If even during this latter period no cases no hypoglycemic episodes occur, at the second control (T2) the dosage will be increased to the maximum of 0.2/U/Kg/die. It is generally accepted that the final dosage of glargine can be tailored to each patient, but it should be maintained between 0.1 and 0.2 U/Kg/die. Glargine should be administered once daily in the morning and always at the same hour. | Drug | 1 |
Primary outcome
Nutritional status evaluated as variations of Z score of BMI
Time frame: At recruitment time and at +3, +6, +9, +12, +15, +18 months
1 secondary outcome
Glucose tolerance improvement evaluated as improvement of glycometabolic parameter (glycosylated Hb)
Time frame: At time recruitment and +3,+6,+9+12+15+18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2009.
- Background: PubMed 10499886Moran A, Hardin D, Rodman D, Allen HF, Beall RJ, Borowitz D, Brunzell C, Campbell PW 3rd, Chesrown SE, Duchow C, Fink RJ, Fitzsimmons SC, Hamilton N, Hirsch I, Howenstine MS, Klein DJ, Madhun Z, Pencharz PB, Quittner AL, Robbins MK, Schindler T, Schissel K, Schwarzenberg SJ, Stallings VA, Zipf WB, et al. Diagnosis, screening and management of cystic fibrosis related diabetes mellitus: a consensus conference report. Diabetes Res Clin Pract. 1999 Aug;45(1):61-73. doi: 10.1016/s0168-8227(99)00058-3. No abstract available.
- Background: PubMed 12786675Mackie AD, Thornton SJ, Edenborough FP. Cystic fibrosis-related diabetes. Diabet Med. 2003 Jun;20(6):425-36. doi: 10.1046/j.1464-5491.2003.00924.x.
- Background: PubMed 12584532Solomon MP, Wilson DC, Corey M, Kalnins D, Zielenski J, Tsui LC, Pencharz P, Durie P, Sweezey NB. Glucose intolerance in children with cystic fibrosis. J Pediatr. 2003 Feb;142(2):128-32. doi: 10.1067/mpd.2003.5.
- Background: PubMed 1396931Lanng S, Thorsteinsson B, Nerup J, Koch C. Influence of the development of diabetes mellitus on clinical status in patients with cystic fibrosis. Eur J Pediatr. 1992 Sep;151(9):684-7. doi: 10.1007/BF01957574.
- Background: PubMed 10988101Milla CE, Warwick WJ, Moran A. Trends in pulmonary function in patients with cystic fibrosis correlate with the degree of glucose intolerance at baseline. Am J Respir Crit Care Med. 2000 Sep;162(3 Pt 1):891-5. doi: 10.1164/ajrccm.162.3.9904075.
- Background: PubMed 12390923Dobson L, Hattersley AT, Tiley S, Elworthy S, Oades PJ, Sheldon CD. Clinical improvement in cystic fibrosis with early insulin treatment. Arch Dis Child. 2002 Nov;87(5):430-1. doi: 10.1136/adc.87.5.430. No abstract available.
- Background: PubMed 15699230Rafii M, Chapman K, Stewart C, Kelly E, Hanna A, Wilson DC, Tullis E, Pencharz PB. Changes in response to insulin and the effects of varying glucose tolerance on whole-body protein metabolism in patients with cystic fibrosis. Am J Clin Nutr. 2005 Feb;81(2):421-6. doi: 10.1093/ajcn.81.2.421.
- Background: PubMed 11529531Rolon MA, Benali K, Munck A, Navarro J, Clement A, Tubiana-Rufi N, Czernichow P, Polak M. Cystic fibrosis-related diabetes mellitus: clinical impact of prediabetes and effects of insulin therapy. Acta Paediatr. 2001 Aug;90(8):860-7.
- Background: PubMed 11430710Nousia-Arvanitakis S, Galli-Tsinopoulou A, Karamouzis M. Insulin improves clinical status of patients with cystic-fibrosis-related diabetes mellitus. Acta Paediatr. 2001 May;90(5):515-9.
- Background: PubMed 15209760Dobson L, Sheldon CD, Hattersley AT. Conventional measures underestimate glycaemia in cystic fibrosis patients. Diabet Med. 2004 Jul;21(7):691-6. doi: 10.1111/j.1464-5491.2004.01219.x.
- Background: PubMed 12824866Lombardo F, De Luca F, Rosano M, Sferlazzas C, Lucanto C, Arrigo T, Messina MF, Crisafulli G, Wasniewska M, Valenzise M, Cucinotta D. Natural history of glucose tolerance, beta-cell function and peripheral insulin sensitivity in cystic fibrosis patients with fasting euglycemia. Eur J Endocrinol. 2003 Jul;149(1):53-9. doi: 10.1530/eje.0.1490053.
- Background: PubMed 16682829Bizzarri C, Lucidi V, Ciampalini P, Bella S, Russo B, Cappa M. Clinical effects of early treatment with insulin glargine in patients with cystic fibrosis and impaired glucose tolerance. J Endocrinol Invest. 2006 Mar;29(3):RC1-4. doi: 10.1007/BF03345538.
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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.
Laura Minicucci, MD principal investigator
G.Gaslini Institute Pediatric Department CF Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin in people with Cystic Fibrosis and Glucose Intolerance, run by Fondazione per la ricerca sulla Fibrosi Cistica at 6 sites in Italy.
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 8 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in 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?
Results are not available in the source record.
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?
Nutritional status evaluated as variations of Z score of BMI (time frame: At recruitment time and at +3, +6, +9, +12, +15, +18 months). 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 NCT00687466, which also lists 13 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 4 Aug 2009.