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

Conditions: Cystic fibrosis-related diabetes
MedDRA version: 9.1Level: HLTClassification code 10012602Term: Diabetes mellitus (incl subtypes)
MedDRA version: 9.1Level: LLTClassification code 10011762Term: Cystic fibrosis

Registration Number: EUCTR2009-009875-37-NL

Lead Sponsor: Staf Longziekten

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 25

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;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).<br>Insulin sensitivity determined by HOMA-IR.<br><br>HOMA-IR = (FPI x FPG)/22.5 <br>(FPI = fasting plasma insulin concentration (mU/l); FPG = fasting plasma glucose (mmol/l))<br>;Primary end point(s): Daily insulin need<br>HbA1c levels

Secondary Outcome Measures