Please select the eligibility criteria that correspond to the clinical trial below.
Title: Open Randomised Prospective Comparative Multi-centre Intervention Study of Patients With Cystic Fibrosis and Early Diagnosed Diabetes Mellitus
Brief Summary: Is oral therapy with Repaglinide equivalent to insulin therapy with three daily injections with respect to blood glucose control, weight and pulmonary function over 2 years in patients with cystic fibrosis and secondary diabetes mellitus? That is the question examined in the phase III trial.


Options:
A: * Diabetic glucose pattern by oral glucose tolerance test (OGTT) of \>200 at 120 min. (stable and healthy at time of OGTT)
* Fasting glucose levels \<126.
* Weight stable within 5% in previous 3 months.
* Free from illness for two months.
* Male and female 16 and older, who are done growing
* Willing to come in for visits every 3 months.
* Patients receiving infrequent short bursts of systemic glucocorticoids may be considered for the study inclusion if: a. they have not received systemic glucocorticoids steroids for at least one month, b. they did not receive the steroids for more than 14 consecutive days or 28 days total in six months
B: Inclusion Criteria:

* CF as diagnosed by:

  1. Documented sweat chloride greater than or equal to 60 mEq/L by quantitative pilocarpine iontophoresis test; or
  2. Two well-characterized genetic mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; or
  3. Abnormal nasal potential difference with accompanying symptoms characteristic of CF.
* PA present in expectorated sputum or throat swab culture at Screening.
* Participants must have received three or more courses of TIS within the previous 12 months.
* Participants on chronic azithromycin must have had no change in regimen in the previous 3 months and must have had a need for TIS and/or additional antipseudomonal therapy since initiation of azithromycin.
* Forced expiratory volume in 1 second (FEV1) between (and including) 25% and 75% predicted at Screening.
* Ability to perform reproducible pulmonary function tests.
* Arterial oxygen saturation (SaO2) greater than or equal to 90% on room air at Screening.

Exclusion Criteria:

* Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone a day or 20 mg prednisone every other day.
* History of sputum or throat culture swab yielding Burkholderia cepacia in the past 2 years.
* History of daily continuous oxygen supplementation or requirement for more than 2 liters/minute at night.
* Administration of any investigational drug or device within 28 days of Screening (Visit 1) or within 6 half-lives of the investigational drug (whichever was longer).
* Known local or systemic hypersensitivity to monobactam antibiotics.
* Inability to tolerate inhalation of a short acting Beta-2 agonist.
* Changes in antimicrobial, bronchodilator, anti-inflammatory, or corticosteroid medications within 7 days before Screening or between Screening and the next visit.
* Changes in physiotherapy technique or schedule within 7 days before Screening or between Screening and the next visit.
* History of lung transplantation.
* A chest X-ray indicating abnormal findings at Screening or within the previous 90 days.
* Abnormal renal or hepatic function or serum chemistry at Screening (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\] greater than 5 times the upper limit of normal range; Creatinine greater than 2 times the upper limit of normal range).
* Positive pregnancy test at Screening.
* Female of childbearing potential who was lactating or in the opinion of the investigator was not practicing acceptable birth control.
* Any serious or active medical or psychiatric illness, which in the opinion of the investigator would have interfered with participant treatment, assessment, or compliance with the protocol.
C: Inclusion Criteria :

* Men or women 18 years and older.
* Diagnosis of CF documented.
* Obstructive ventilatory deficit light to moderate , as defined in the guidelines of the ATS / ERS , an FEV / FVC ratio \> 70% and ≥ 40% FEV .
* Stable health status, no episode of superinfection in the past 6 weeks.
* Impaired glucose tolerance , glucose \> 11.1 mmol / L at the 1st hour of the OGTT or unmedicated CFRD.
* Patients who wants to participate in an exercise program for 12 weeks.
* Sedentary (less than 105 min / week of physical activity ) .

Exclusion Criteria :

* Exacerbation of respiratory symptoms with or without hospitalization , or use of oral antibiotics in the last 6 weeks.
* Exacerbation with intravenous antibiotics .
* Severe obstructive deficit as defined by FEV \<40% , with an FEV / FVC ratio \<70 %.
* Any other disease or condition that may limit exercise performance .
* Without treatment with oral hypoglycemia , insulin, oral anti -inflammatory and other treatments that may influence glucose metabolism (patient under cortef accepted) .
* Hemoptysis ( \> 50-60 cc) in the last 6 weeks.
* Desaturation during exercise.
D: Inclusion Criteria:

Inclusion Criteria for the Screening:

* Diagnosed cystic fibrosis
* Age 10 years and older

Inclusion Criteria for the therapeutic part of the study:

* Newly diagnosed Diabetes mellitus in the screening

Exclusion Criteria:

Exclusion Criteria for Screening:

* Diabetic keto-acidosis (blood glucose \> 350 mg/dl and arterial pH \< 7.25)
* Already treated Diabetes mellitus by oral antidiabetic medication or insulin

Exclusion Criteria for the therapeutic part of the study:

* Systemic steroid therapy during the last 3 months
* Transplantation (status post TX or on the waiting list for TX)
* Beginning pulmonary insufficiency, FEV1 \< 35% at pulmonary function test in stable condition
* Pregnancy
* Already diagnosed and treated diabetes mellitus
* Patients with diabetic keto-acidosis (blood glucose \> 350 mg/dl and arterial pH \< 7.25) with or without diabetic coma
* Severe liver insufficiency (chronic hepatitis B, AST or ALT twice the upper limit of normal, Quick's value \< 70% which is a contraindication to use Repaglinide)
* Treatment with an indispensable important drug which contraindicates Repaglinide
* PEG/ gastric tube/ total parenteral alimentation for more than 4 weeks during the study
* CF-patients with type 1 diabetes
* Not patient's consent to randomisation and therapeutic trial
* Participation on other medical trial

Answer: D