Insulin and oral agents for managing cystic fibrosis-related diabetes

Wright State University, Dayton, Ohio, United States
Cochrane database of systematic reviews (Online) (Impact Factor: 6.03). 02/2005; 7(3):CD004730. DOI: 10.1002/14651858.CD004730.pub2
Source: PubMed


Cystic fibrosis is a serious genetic disorder damaging the lungs and pancreas (an organ essential for sugar metabolism). People with cystic fibrosis need high calorie diets to manage breathing difficulties resulting from their lung damage; optimizing sugar metabolism is, therefore, an important therapeutic goal. Adequate sugar metabolism is linked to outcome measures such as managing breathing difficulties and maintaining ideal body weight. We were only able to include one randomized trial which met the inclusion criteria (post-meal glucose control) in this review. This trial was short term (five hours post-meal) with only seven participants with cystic fibrosis-related diabetes who had normal fasting blood sugars. The trial reported significant results in favour insulin over repaglinide for blood glucose levels at five hours post-meal, but the amounts of insulin and repaglinide received were not comparable and this may lead to bias in the results. A small number of cases of hypoglycemia were reported, but these were resolved without further treatment.

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    • "Guidelines recommend insulin as first line treatment [2]. Nevertheless there are many centers which use oral antidiabetic drugs for treatment of CFRD [3]. The reasons for this off label use might be the hope to reduce the treatment burden which is even without CFRD very high in CF [12,13]. "
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    ABSTRACT: Diabetes mellitus may be present in patients with cystic fibrosis starting in the second decade of life. The prevalence increases rapidly with increasing age. As life-expectancy increases in cystic fibrosis, cystic fibrosis related diabetes will be diagnosed more frequently in the future.Up to date, no data are available to answer the question if cystic fibrosis related diabetes should always initially be treated by insulin therapy. Missing data regarding oral antidiabetic treatment of newly diagnosed cystic fibrosis related diabetes are an important reason to recommend insulin treatment. Several centres report the successful management of cystic fibrosis related diabetes using oral anti-diabetic drugs at least for some years. Oral therapies would be less invasive for a patient group which is highly traumatized by a very demanding therapy. Based on an initiative of the German Mukoviszidosis-Foundation, the present study tries to answer the question, whether oral therapy with repaglinide is as effective as insulin therapy in cystic fibrosis patients with early diagnosed diabetes mellitus. In all cystic fibrosis patients with an age of 10 years or older, an oral glucose tolerance test is recommended. The result of this test is classified according to the WHO cut off values. It is required to have two diabetes positive oral glucose tolerance tests for the diagnosis of diabetes mellitus.This study is a multi-national, multicentre, open labelled, randomized and prospective controlled parallel group's trial, with 24 months treatment.The primary objective of this trial is to compare the glycaemic control of oral therapy with Repaglinide with insulin injections in patients with cystic fibrosis related diabetes after 2 years of treatment.The trial should include 74 subjects showing cystic fibrosis related diabetes newly diagnosed by oral glucose tolerance test during annual screening for cystic fibrosis related diabetes.Patients are randomised by central fax randomisation.Primary endpoint is mean HbA1c after 24 months of treatment. Secondary endpoints are change in FEV1% predicted and change in BMI-Z-score. There is only one prospective study comparing oral antidiabetic drugs to insulin in the treatment of CFRD without fasting hyperglycaemia. The results regarding BMI after 6 months and 12 months showed an improvement for the insulin treated patients and were inconsistent for those treated with repaglinide. HbA1c and lung function (FEV1%pred) were unchanged for either group. The authors compared the changes -12 months to baseline and baseline to +12 months separately for each group. Therefore a direct comparison of the effect of repaglinide versus insulin on BMI, HbA1c and FEV1%pred was not presented. According to our protocol, we will directly compare treatment effects (HbA1c, BMI, FEV1%pred) in between both groups. The actual Cochrane report regarding "Insulin and oral agents for managing CFRD" stated that further studies are needed to establish whether there is clear benefit for hypoglycemic agents. We expect that the results of our study will help to address this clinical need.Trial registration: Identifier: NCT00662714.
    BMC Pediatrics 03/2014; 14(1):70. DOI:10.1186/1471-2431-14-70 · 1.93 Impact Factor
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