Pilot Study of Glycemic Control in Diabetic Hemodialyzed Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01828970
• Date of registration: 09/04/2013
• Prospective Registration: No
• Primary sponsor: Centre Europeen d'Etude du Diabete
• Public title: Pilot Study of Glycemic Control in Diabetic Hemodialyzed Patients GlyCEDIA
• Scientific 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
• Date of first enrolment: January 2010
• Target sample size: 38
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01828970
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Laurence Kessler, PhD
• Affiliation: University Hospital of Strasbourg

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: 83 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus

Intervention(s)

Drug: Basal-bolus detemir-aspart insulin regimen

Primary Outcome(s)

Mean plasma glucose level measured 3 times just before the first hemodialysis session [Time Frame: Baseline and at 3 months of treatment]

Secondary Outcome(s)

Symptomatic hypoglycemia [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]

Continuous glucose monitoring parameters [Time Frame: Baseline and at 1 month and 3 months of treatment]

Body weight [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]

HbA1c [Time Frame: Baseline and at 3 months of treatment]

Secondary ID(s)

09/43

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Abbott

Novo Nordisk A/S