Diabetes MellitusPhase 4GlyCEDIANCT01828970

Pilot Study of Glycemic Control in Diabetic Hemodialyzed Patients

A Phase 4 study testing Basal-bolus detemir-aspart insulin regimen in people with Diabetes Mellitus, run by Centre Europeen d'Etude du Diabete at 5 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to evaluate the effect of the basal-bolus detemir-aspart insulin regimen coupled with continuous glucose monitoring (CGM) on glycemic control in hemodialyzed patients with diabetes Read more about this study

Who is it for?: Ages 18 to 83 years
Conditions the study is for: Diabetes Mellitus
What is being tested?: Basal-bolus detemir-aspart insulin regimen
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 5 sitesFrance
Study dates: Jan 2010to Sep 2012
Phase: Phase 4
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 18 to 83 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

age between 18 and 83 years
diagnosis of type 1 or type 2 diabetes
treatment with insulin injections or oral hypoglycemic agents
HbA1c ≥ 7% (i.e., 53 mmol/mol)
on hemodialysis for more than three months

Who cannot join

unstable anemia or blood transfusions within the two months prior to the beginning of the study
a life expectancy of less than 1 year
chronic inflammatory disease
evolutive cancer requiring steroid treatment, chemotherapy, radiotherapy, or programmed surgery
noncompliant patients

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

France5 sites

Regional Hospital of Colmar
Colmar, 68000
Regional Hospital of Mulhouse
Mulhouse, 68100
Sainte Anne Hospital
Strasbourg, 67000
University Hospital of Strasbourg
Strasbourg, 67000
Regional Hospital of Valenciennes
Valenciennes, 59300

Other trials in France

About this study

Official title: Glycemic Control Assessed by Continuous Glucose Monitoring in Hemodialyzed Patients With Diabetes Mellitus Treated Via the Basal-Bolus Detemir-Aspart Insulin Regimen: A Pilot Study

Read the detailed description

We conducted a pilot prospective multicenter study in five French centers (Strasbourg University Hospital, Strasbourg Sainte Anne Hospital, Colmar, Mulhouse, Valenciennes) designed to evaluate the feasibility and effects of a 3 month treatment regimen with rapid-acting insulin and basal long-acting insulin analogues (i.e., aspart and detemir, respectively) along with CGM on glucose level control in diabetic hemodialyzed patients.

All patients who were admitted to the nephrology departments and matched the inclusion criteria between January 1st, 2010, and June 30th, 2012, were consecutively included in the study. CGM was used to analyze blood glucose excursions at baseline and 1 and 3 months of treatment. It was started during the first dialysis session and then continued for the next two days at home under ambulatory conditions. The CGM was continued during the next dialysis session. Therefore, in total, CGM (Navigator®; Abbott, Rungis, France) was performed for 54 hours, including two consecutive hemodialysis sessions and at 0, 1, and 3 months of treatment. The probe for the system was subcutaneously inserted at the beginning of the first dialysis session to analyze interstitial glucose, and it was removed at the end of the second dialysis session. Due to the time required for CGM calibration, plasma glucose levels were only partially recorded during the first dialysis session.

Conditions: Diabetes Mellitus
Being tested: Basal-bolus detemir-aspart insulin regimen
Keywords: Diabetes Mellitus, Hemodialysis, Continuous glucose monitoring, Insulin analogues
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Basal-bolus detemir-aspart insulin regimenDrug
Also called Levemir, Novorapid
After the first CGM was completed during the conventional anti-diabetic treatment, patients received a rapid-acting insulin analogue before each meal (i.e., aspart) and a basal long-acting insulin analogue (i.e., detemir) once or twice daily. The analogues were titrated for optimal glycemic control. After one month of the aspart and detemir regimen, a physician adapted the insulin doses according to the glucose values observed from the second CGM.

Study groups in NCT01828970
Study group	Role	What they receive
Basal-bolus specific insulin regimen	Experimental	Basal-bolus detemir-aspart insulin regimen in hemodialyzed diabetic patients Receives: Drug: Basal-bolus detemir-aspart insulin regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean plasma glucose level measured 3 times just before the first hemodialysis session
Determination by the glucose dehydrogenase method
Measured: Baseline and at 3 months of treatment

Secondary outcomes (6)

HbA1c
Measured by high-performance liquid chromatography
Measured: Baseline and at 3 months of treatment
Body weight
Measured: Baseline and at 1 month and 3 months of treatment
Insulin requirements
IU per day
Measured: Baseline and at 1 month and 3 months of treatment
Symptomatic hypoglycemia
Number of glycemia < 60 mg/dl per patient and per month
Measured: Baseline and at 1 month and 3 months of treatment
Continuous glucose monitoring parameters
Including: mean continuous glucose monitoring glucose values, within-subjects standard deviation (wSD) and coefficient of variation (wCV = wSD/mean), mean amplitude of glycemic excursion (MAGE), frequency of glucose values under 60 mg/dl, and frequency of glucose values higher than 180 mg/dl
Measured: Baseline and at 1 month and 3 months of treatment
Deaths and major cardiovascular events
All-cause mortality Major cardiovascular events including: myocardial infarction, stroke, and peripheral vascular disease
Measured: Baseline and at 3 months of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Sep 2012

First posted11 Apr 2013 (estimated)
Study startJan 2010
Primary completionSep 2012
Study completionSep 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (30)Papers the sponsor has linked to this study.
Other trials for Diabetes MellitusStudies 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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01828970
Sponsor's protocol ID: 09/43
Acronym: GlyCEDIA
Status last verified: Apr 2013
First submitted: 9 Apr 2013
Last updated: 11 Apr 2013
Results posted: No
Data monitoring committee: No

Publications

U S Renal Data System, USRDS 2012 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2012. Available from http://www.usrds.org/atlas.aspx
Heras M, Fernandez-Reyes MJ, Sanchez R, Guerrero MT, Molina A, Rodriguez MA, Alvarez-Ude F. Elderly patients with chronic kidney disease: outcomes after 5 years of follow-up. Nefrologia. 2012 May 14;32(3):300-5. doi: 10.3265/Nefrologia.pre2012.Jan.10994. Epub 2012 Feb 28. English, Spanish.
PubMed 22508140
Pieringer H, Biesenbach G. Hemodialysis in patients older than 65 years with end-stage renal failure--comparison of outcome in patients with and without diabetes. Z Gerontol Geriatr. 2008 Apr;41(2):139-45. doi: 10.1007/s00391-007-0467-x. Epub 2008 Mar 11.
PubMed 18327697
Sattar A, Argyropoulos C, Weissfeld L, Younas N, Fried L, Kellum JA, Unruh M. All-cause and cause-specific mortality associated with diabetes in prevalent hemodialysis patients. BMC Nephrol. 2012 Oct 1;13:130. doi: 10.1186/1471-2369-13-130.
PubMed 23025844
Oomichi T, Emoto M, Tabata T, Morioka T, Tsujimoto Y, Tahara H, Shoji T, Nishizawa Y. Impact of glycemic control on survival of diabetic patients on chronic regular hemodialysis: a 7-year observational study. Diabetes Care. 2006 Jul;29(7):1496-500. doi: 10.2337/dc05-1887.
PubMed 16801568
Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
PubMed 8366922
Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53.
PubMed 9742976
McMurray SD, Johnson G, Davis S, McDougall K. Diabetes education and care management significantly improve patient outcomes in the dialysis unit. Am J Kidney Dis. 2002 Sep;40(3):566-75. doi: 10.1053/ajkd.2002.34915.
PubMed 12200809
Okada T, Nakao T, Matsumoto H, Shino T, Nagaoka Y, Tomaru R, Wada T. Association between markers of glycemic control, cardiovascular complications and survival in type 2 diabetic patients with end-stage renal disease. Intern Med. 2007;46(12):807-14. doi: 10.2169/internalmedicine.46.6355. Epub 2007 Jun 15.
PubMed 17575371
Action to Control Cardiovascular Risk in Diabetes Study Group; Gerstein HC, Miller ME, Byington RP, Goff DC Jr, Bigger JT, Buse JB, Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH Jr, Probstfield JL, Simons-Morton DG, Friedewald WT. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2545-59. doi: 10.1056/NEJMoa0802743. Epub 2008 Jun 6.
PubMed 18539917
ACCORD Study Group; Cushman WC, Evans GW, Byington RP, Goff DC Jr, Grimm RH Jr, Cutler JA, Simons-Morton DG, Basile JN, Corson MA, Probstfield JL, Katz L, Peterson KA, Friedewald WT, Buse JB, Bigger JT, Gerstein HC, Ismail-Beigi F. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med. 2010 Apr 29;362(17):1575-85. doi: 10.1056/NEJMoa1001286. Epub 2010 Mar 14.
PubMed 20228401
Riveline JP, Teynie J, Belmouaz S, Franc S, Dardari D, Bauwens M, Caudwell V, Ragot S, Bridoux F, Charpentier G, Marechaud R, Hadjadj S. Glycaemic control in type 2 diabetic patients on chronic haemodialysis: use of a continuous glucose monitoring system. Nephrol Dial Transplant. 2009 Sep;24(9):2866-71. doi: 10.1093/ndt/gfp181. Epub 2009 Apr 23.
PubMed 19389864
Kazempour-Ardebili S, Lecamwasam VL, Dassanyake T, Frankel AH, Tam FW, Dornhorst A, Frost G, Turner JJ. Assessing glycemic control in maintenance hemodialysis patients with type 2 diabetes. Diabetes Care. 2009 Jul;32(7):1137-42. doi: 10.2337/dc08-1688. Epub 2009 Feb 5.
PubMed 19196889
Vos FE, Schollum JB, Coulter CV, Manning PJ, Duffull SB, Walker RJ. Assessment of markers of glycaemic control in diabetic patients with chronic kidney disease using continuous glucose monitoring. Nephrology (Carlton). 2012 Feb;17(2):182-8. doi: 10.1111/j.1440-1797.2011.01517.x.
PubMed 21883672
Ersoy A, Ersoy C, Altinay T. Insulin analogue usage in a haemodialysis patient with type 2 diabetes mellitus. Nephrol Dial Transplant. 2006 Feb;21(2):553-4. doi: 10.1093/ndt/gfi205. Epub 2005 Oct 12. No abstract available.
PubMed 16221693

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Glycemic Control Assessed by Continuous Glucose Monitoring in Hemodialyzed Patients With Diabetes Mellitus Treated Via the Basal-Bolus Detemir-Aspart Insulin Regimen: A Pilot Study
ClinicalTrials.gov ID: NCT01828970
Acronym / sponsor ID: GlyCEDIA / 09/43
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus, Hemodialysis, Continuous glucose monitoring, Insulin analogues
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Centre Europeen d'Etude du DiabeteUniversity, hospital or other
Collaborators: Novo Nordisk A/S, Abbott
Study start: Jan 2010
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 11 Apr 2013 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Basal-bolus specific insulin regimen	Experimental	Drug: Basal-bolus detemir-aspart insulin regimenBasal-bolus detemir-aspart insulin regimen in hemodialyzed diabetic patients

Who may qualify

Ages: 18 to 83 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

age between 18 and 83 years
diagnosis of type 1 or type 2 diabetes
treatment with insulin injections or oral hypoglycemic agents
HbA1c ≥ 7% (i.e., 53 mmol/mol)
on hemodialysis for more than three months

Key exclusion criteria (5 listed)

unstable anemia or blood transfusions within the two months prior to the beginning of the study
a life expectancy of less than 1 year
chronic inflammatory disease
evolutive cancer requiring steroid treatment, chemotherapy, radiotherapy, or programmed surgery
noncompliant patients

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
Basal-bolus detemir-aspart insulin regimenAlso: Levemir, NovorapidAfter the first CGM was completed during the conventional anti-diabetic treatment, patients received a rapid-acting insulin analogue before each meal (i.e., aspart) and a basal long-acting insulin analogue (i.e., detemir) once or twice daily. The analogues were titrated for optimal glycemic control. After one month of the aspart and detemir regimen, a physician adapted the insulin doses according to the glucose values observed from the second CGM.	Drug	Basal-bolus specific insulin regimen

Primary outcome

Mean plasma glucose level measured 3 times just before the first hemodialysis session
Time frame: Baseline and at 3 months of treatment
Determination by the glucose dehydrogenase method

6 secondary outcomes

HbA1c
Time frame: Baseline and at 3 months of treatment
Body weight
Time frame: Baseline and at 1 month and 3 months of treatment
Insulin requirements
Time frame: Baseline and at 1 month and 3 months of treatment
Symptomatic hypoglycemia
Time frame: Baseline and at 1 month and 3 months of treatment
Continuous glucose monitoring parameters
Time frame: Baseline and at 1 month and 3 months of treatment
Deaths and major cardiovascular events
Time frame: Baseline and at 3 months of treatment

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 11 Apr 2013.
BackgroundU S Renal Data System, USRDS 2012 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2012. Available from http://www.usrds.org/atlas.aspx
Background: PubMed 22508140Heras M, Fernandez-Reyes MJ, Sanchez R, Guerrero MT, Molina A, Rodriguez MA, Alvarez-Ude F. Elderly patients with chronic kidney disease: outcomes after 5 years of follow-up. Nefrologia. 2012 May 14;32(3):300-5. doi: 10.3265/Nefrologia.pre2012.Jan.10994. Epub 2012 Feb 28. English, Spanish.
Background: PubMed 18327697Pieringer H, Biesenbach G. Hemodialysis in patients older than 65 years with end-stage renal failure--comparison of outcome in patients with and without diabetes. Z Gerontol Geriatr. 2008 Apr;41(2):139-45. doi: 10.1007/s00391-007-0467-x. Epub 2008 Mar 11.
Background: PubMed 23025844Sattar A, Argyropoulos C, Weissfeld L, Younas N, Fried L, Kellum JA, Unruh M. All-cause and cause-specific mortality associated with diabetes in prevalent hemodialysis patients. BMC Nephrol. 2012 Oct 1;13:130. doi: 10.1186/1471-2369-13-130.
Background: PubMed 16801568Oomichi T, Emoto M, Tabata T, Morioka T, Tsujimoto Y, Tahara H, Shoji T, Nishizawa Y. Impact of glycemic control on survival of diabetic patients on chronic regular hemodialysis: a 7-year observational study. Diabetes Care. 2006 Jul;29(7):1496-500. doi: 10.2337/dc05-1887.
Background: PubMed 8366922Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
Background: PubMed 9742976Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53.
Background: PubMed 12200809McMurray SD, Johnson G, Davis S, McDougall K. Diabetes education and care management significantly improve patient outcomes in the dialysis unit. Am J Kidney Dis. 2002 Sep;40(3):566-75. doi: 10.1053/ajkd.2002.34915.
Background: PubMed 17575371Okada T, Nakao T, Matsumoto H, Shino T, Nagaoka Y, Tomaru R, Wada T. Association between markers of glycemic control, cardiovascular complications and survival in type 2 diabetic patients with end-stage renal disease. Intern Med. 2007;46(12):807-14. doi: 10.2169/internalmedicine.46.6355. Epub 2007 Jun 15.
Background: PubMed 18539917Action to Control Cardiovascular Risk in Diabetes Study Group; Gerstein HC, Miller ME, Byington RP, Goff DC Jr, Bigger JT, Buse JB, Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH Jr, Probstfield JL, Simons-Morton DG, Friedewald WT. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2545-59. doi: 10.1056/NEJMoa0802743. Epub 2008 Jun 6.
Background: PubMed 20228401ACCORD Study Group; Cushman WC, Evans GW, Byington RP, Goff DC Jr, Grimm RH Jr, Cutler JA, Simons-Morton DG, Basile JN, Corson MA, Probstfield JL, Katz L, Peterson KA, Friedewald WT, Buse JB, Bigger JT, Gerstein HC, Ismail-Beigi F. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med. 2010 Apr 29;362(17):1575-85. doi: 10.1056/NEJMoa1001286. Epub 2010 Mar 14.
Background: PubMed 19389864Riveline JP, Teynie J, Belmouaz S, Franc S, Dardari D, Bauwens M, Caudwell V, Ragot S, Bridoux F, Charpentier G, Marechaud R, Hadjadj S. Glycaemic control in type 2 diabetic patients on chronic haemodialysis: use of a continuous glucose monitoring system. Nephrol Dial Transplant. 2009 Sep;24(9):2866-71. doi: 10.1093/ndt/gfp181. Epub 2009 Apr 23.

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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.

Laurence Kessler, PhD study director

University Hospital of Strasbourg

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Basal-bolus detemir-aspart insulin regimen in people with Diabetes Mellitus, run by Centre Europeen d'Etude du Diabete at 5 sites in France.

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 5 inclusion and 5 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 11 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Mean plasma glucose level measured 3 times just before the first hemodialysis session (time frame: Baseline and at 3 months of treatment). 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 NCT01828970, which also lists 30 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 11 Apr 2013.