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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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10 June 2013 |
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Main ID: |
EUCTR2009-009875-37-NL |
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Date of registration:
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21/01/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A placebo-controlled trial of insulin therapy with or without adjuvant metformin in patients with cystic fibrosis-related diabetes - Insulin therapy and adjuvant metformin in CFRD
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Scientific title:
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A placebo-controlled trial of insulin therapy with or without adjuvant metformin in patients with cystic fibrosis-related diabetes - Insulin therapy and adjuvant metformin in CFRD |
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Date of first enrolment:
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11/03/2009 |
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Target sample size:
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25 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-009875-37 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Subjects included in the study, will be adult patients (age > 18 years) diagnosed with cystic fibrosis-related diabetes for at least one year, stable disease and regularly attending our outpatient clinic.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Exclusion criteria are: pregnancy, pregnancy wish, transplantation, on waiting list for transplantation, planned surgical procedures, proven cystic fibrosis liver disease or other hepatic disease, proven type 1 diabetes mellitus, renal insufficiency (creatinine clearance < 50ml/min), sepsis, alcohol abuse, severe cardiovascular disease, permanent oxygen use, FEV1 % predicted < 30% and BMI < 19.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Cystic fibrosis-related diabetes
MedDRA version: 9.1
Level: HLT
Classification code 10012602
Term: Diabetes mellitus (incl subtypes)
MedDRA version: 9.1
Level: LLT
Classification code 10011762
Term: Cystic fibrosis
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Intervention(s)
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Trade Name: Metformine HCL 500 PCH
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Secondary Objective: Results from a three-day continuous glucose monitoring (39), body weight, and overall clinical status, expressed as pulmonary functions, number of pulmonary exacerbations, and antibiotics use. Results from a validated quality of life questionnaire for CF patients (40).
Insulin sensitivity determined by HOMA-IR.
HOMA-IR = (FPI x FPG)/22.5
(FPI = fasting plasma insulin concentration (mU/l); FPG = fasting plasma glucose (mmol/l))
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Main Objective: Investigate the total amount of insulin needed between use of insulin alone and combination therapy with insulin and metformin. Thereby investigate metabolic control, expressed as HbA1c blood levels between both treatment periods.
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Primary end point(s): Daily insulin need
HbA1c levels
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Source(s) of Monetary Support
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Results
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Results available:
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