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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-009875-37-NL

Enrollment

Registered

2009-01-21

Start date

2009-03-11

Completion date

Unknown

Last updated

2013-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Metformine HCL 500 PCH Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

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: 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.

Design outcomes

Primary

Measure	Time frame
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). 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)) ;Primary end point(s): Daily insulin need HbA1c levels	—

Measure

Time frame

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). 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)) ;Primary end point(s): Daily insulin need HbA1c levels

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026