Cystic Fibrosis Related DiabetesPhase 2/3NCT00639626
Use of Levemir® Improves Metabolic and Clinical Status in Cystic Fibrosis-related Diabetes (CFRD)
A Phase 2/3 study testing insulin detemir [rDNA origin] injection in people with Cystic Fibrosis Related Diabetes, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
This is a study to find out if Levemir® (a long acting or basal insulin) is safe and effective in treating cystic fibrosis related diabetes (CFRD). Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Cystic Fibrosis Related Diabetes
- What is being tested?
- insulin detemir [rDNA origin] injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to May 2010
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients diagnosed with CFRD by oral glucose tolerance test (OGTT) who are medically stable. Medical stability will be defined as:
- No hospital admission for six weeks or more before the study
- No oral or intravenous antibiotics for at least six weeks preceding the study (subjects will be allowed to use low doses of inhaled corticosteroids).
Who cannot join
- Use of oral or intravenous corticosteroid medications within six weeks of the study.
- Evidence of clinically significant liver disease.
- Colonization with Burkholderia cepacia.
- Colonization with Aspergillus.
- Pregnancy.
- Medically unstable (stability defined above).
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Use of Levemir® Improves Metabolic and Clinical Status in CFRD
This is a study to find out if Levemir® (a long acting or basal insulin) is safe and effective in treating cystic fibrosis related diabetes (CFRD).
Read the detailed description
Cystic fibrosis (CF) related diabetes (CFRD) and glucose intolerance affects more than 50%-75% of teens and adults with CF. The 1998 North American CF Foundation on CFRD categorized the disease differently than other types of diabetes: CFRD with fasting hyperglycemia (FH), CFRD without FH and transient CFRD. The outcome of this consensus conference was the use of insulin as the only recommended treatment of CFRD. Although the conference report mandated treatment for CFRD with FH, treatment was not mandated for the other types of CFRD, the choice to treat was left to the clinician's discretion. However, insulin was the only recommended therapy for all types of CFRD. Although some clinicians have used basal bolus regimens as the insulin management, many still use NPH. Given the need for CF patients to eat many frequent meals and snacks to maintain their weight, use of NPH insulin rarely renders good glycemic control. A basal bolus regimen is much more physiologic and would allow good glycemic control even with frequent meals and snacks. To date, there are no studies documenting safety and efficacy of true basal insulin, or a basal bolus regimen. Furthermore, protein catabolism and excessive muscle loss has been well documented in CF patients, both in those with and those without, glucose intolerance. Studies by our group and others have documented that a major reason for the catabolism is resistance to insulin's anti-catabolic effects on protein turnover. Thus, there is potential clinical benefit of improving muscle mass and general health by insulin treatment even for CF patients who do not have fasting hyperglycemia. A non-peaking basal insulin would be the only reasonable choice, yet studies are lacking. Our overall goal is to study the safety and efficacy of LevemirTM for the improvement of glycemic control of patients with CFRD. As a second goal, we will explore the ability of this basal insulin to improve protein catabolism and muscle mass. The study will be conducted as a six month trial.
- Conditions
- Cystic Fibrosis Related Diabetes
- Being tested
- insulin detemir [rDNA origin] injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin detemir [rDNA origin] injectionDrug
Also called Levemir
Starting dose of 0.1-0.3 units/kg/day in a once daily subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Levemir | Experimental | Not described Receives: Drug: insulin detemir [rDNA origin] injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Sugar
Measured: 6 months
Secondary outcomes (1)
Lean Body Mass
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startAug 2008
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: PI left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cystic Fibrosis Related DiabetesStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor
- Investigators
- Dana S. Hardin, MD, Principal investigator, OSU, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639626
- Sponsor's protocol ID
- IRB07-00218
- Status last verified
- Mar 2018
- First submitted
- 14 Mar 2008
- Last updated
- 12 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hardin DS, Moran A. Diabetes mellitus in cystic fibrosis. Endocrinol Metab Clin North Am. 1999 Dec;28(4):787-800, ix. doi: 10.1016/s0889-8529(05)70102-x.
PubMed 10609120Hardin DS, LeBlanc A, Para L, Seilheimer DK. Hepatic insulin resistance and defects in substrate utilization in cystic fibrosis. Diabetes. 1999 May;48(5):1082-7. doi: 10.2337/diabetes.48.5.1082.
PubMed 10331413Moran A, Milla C, Ducret R, Nair KS. Protein metabolism in clinically stable adult cystic fibrosis patients with abnormal glucose tolerance. Diabetes. 2001 Jun;50(6):1336-43. doi: 10.2337/diabetes.50.6.1336.
PubMed 11375334Moran A, Doherty L, Wang X, Thomas W. Abnormal glucose metabolism in cystic fibrosis. J Pediatr. 1998 Jul;133(1):10-17. doi: 10.1016/s0022-3476(98)70171-4. No abstract available.
PubMed 9672504Cucinotta D, Arrigo T, De Luca F, Di Benedetto A, Lombardo F, Scoglio R, Sferlazzas C, Magazzu G. Metabolic and clinical events preceding diabetes mellitus onset in cystic fibrosis. Eur J Endocrinol. 1996 Jun;134(6):731-6. doi: 10.1530/eje.0.1340731.
PubMed 8766944Nir M, Lanng S, Johansen HK, Koch C. Long-term survival and nutritional data in patients with cystic fibrosis treated in a Danish centre. Thorax. 1996 Oct;51(10):1023-7. doi: 10.1136/thx.51.10.1023.
PubMed 8977604
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Levemir® Improves Metabolic and Clinical Status in CFRD
- ClinicalTrials.gov ID
- NCT00639626
- Acronym / sponsor ID
- IRB07-00218
- Conditions
- Cystic Fibrosis Related Diabetes
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left the institution
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- Aug 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 20 Mar 2008 (estimated)
- Results
- Posted 12 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to find out if Levemir® (a long acting or basal insulin) is safe and effective in treating cystic fibrosis related diabetes (CFRD).
Detailed description
Cystic fibrosis (CF) related diabetes (CFRD) and glucose intolerance affects more than 50%-75% of teens and adults with CF. The 1998 North American CF Foundation on CFRD categorized the disease differently than other types of diabetes: CFRD with fasting hyperglycemia (FH), CFRD without FH and transient CFRD. The outcome of this consensus conference was the use of insulin as the only recommended treatment of CFRD. Although the conference report mandated treatment for CFRD with FH, treatment was not mandated for the other types of CFRD, the choice to treat was left to the clinician's discretion. However, insulin was the only recommended therapy for all types of CFRD. Although some clinicians have used basal bolus regimens as the insulin management, many still use NPH. Given the need for CF patients to eat many frequent meals and snacks to maintain their weight, use of NPH insulin rarely renders good glycemic control. A basal bolus regimen is much more physiologic and would allow good glycemic control even with frequent meals and snacks. To date, there are no studies documenting safety and efficacy of true basal insulin, or a basal bolus regimen. Furthermore, protein catabolism and excessive muscle loss has been well documented in CF patients, both in those with and those without, glucose intolerance. Studies by our group and others have documented that a major reason for the catabolism is resistance to insulin's anti-catabolic effects on protein turnover. Thus, there is potential clinical benefit of improving muscle mass and general health by insulin treatment even for CF patients who do not have fasting hyperglycemia. A non-peaking basal insulin would be the only reasonable choice, yet studies are lacking. Our overall goal is to study the safety and efficacy of LevemirTM for the improvement of glycemic control of patients with CFRD. As a second goal, we will explore the ability of this basal insulin to improve protein catabolism and muscle mass. The study will be conducted as a six month trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levemir | Experimental | Drug: insulin detemir [rDNA origin] injection |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients diagnosed with CFRD by oral glucose tolerance test (OGTT) who are medically stable. Medical stability will be defined as:
Key exclusion criteria (6 listed)
- Use of oral or intravenous corticosteroid medications within six weeks of the study.
- Evidence of clinically significant liver disease.
- Colonization with Burkholderia cepacia.
- Colonization with Aspergillus.
- Pregnancy.
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 |
|---|---|---|
| insulin detemir [rDNA origin] injectionAlso: LevemirStarting dose of 0.1-0.3 units/kg/day in a once daily subcutaneous injection. | Drug | Levemir |
Primary outcome
Blood Sugar
Time frame: 6 months
1 secondary outcome
Lean Body Mass
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10609120Hardin DS, Moran A. Diabetes mellitus in cystic fibrosis. Endocrinol Metab Clin North Am. 1999 Dec;28(4):787-800, ix. doi: 10.1016/s0889-8529(05)70102-x.
- Background: PubMed 10331413Hardin DS, LeBlanc A, Para L, Seilheimer DK. Hepatic insulin resistance and defects in substrate utilization in cystic fibrosis. Diabetes. 1999 May;48(5):1082-7. doi: 10.2337/diabetes.48.5.1082.
- Background: PubMed 11375334Moran A, Milla C, Ducret R, Nair KS. Protein metabolism in clinically stable adult cystic fibrosis patients with abnormal glucose tolerance. Diabetes. 2001 Jun;50(6):1336-43. doi: 10.2337/diabetes.50.6.1336.
- Background: PubMed 9672504Moran A, Doherty L, Wang X, Thomas W. Abnormal glucose metabolism in cystic fibrosis. J Pediatr. 1998 Jul;133(1):10-17. doi: 10.1016/s0022-3476(98)70171-4. No abstract available.
- Background: PubMed 8766944Cucinotta D, Arrigo T, De Luca F, Di Benedetto A, Lombardo F, Scoglio R, Sferlazzas C, Magazzu G. Metabolic and clinical events preceding diabetes mellitus onset in cystic fibrosis. Eur J Endocrinol. 1996 Jun;134(6):731-6. doi: 10.1530/eje.0.1340731.
- Background: PubMed 8977604Nir M, Lanng S, Johansen HK, Koch C. Long-term survival and nutritional data in patients with cystic fibrosis treated in a Danish centre. Thorax. 1996 Oct;51(10):1023-7. doi: 10.1136/thx.51.10.1023.
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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.
Dana S. Hardin, MD principal investigator
OSU, Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing insulin detemir [rDNA origin] injection in people with Cystic Fibrosis Related Diabetes, run by Nationwide Children's Hospital at 1 site in United States.
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 6 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: stopped early, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Yes. Results are posted in the registry (first posted 12 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Blood Sugar (time frame: 6 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 NCT00639626, which also lists 6 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 12 Apr 2018.