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primary studies published RCT

Open randomised prospective comparative multi-centre intervention study of patients with cystic fibrosis and early diagnosed diabetes mellitus.

  • Year: 2014
  • Date: 2014
  • Author: Ballmann M
Source

BMC Pediatr. 2014 Mar 11;14:70. doi: 10.1186/1471-2431-14-70.

Study design (if review, criteria of inclusion for studies)

Multi-national, multicentre, open labelled, randomized and prospective controlled parallel group's trial

Participants

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.

Interventions

Repaglinide vs insulin injections.

Outcome measures

Primary endpoint is mean HbA1c after 24 months of treatment. Secondary endpoints are change in FEV1% predicted and change in BMI-Z-score.

Main results

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.

Authors' conclusions

There is only one prospective study comparing oral antidiabetic drugs to insulin in the treatment of CFRD without fasting hyperglycaemia.

Keywords: Adult; Aged; Child; Diabetes Mellitus; Gastrointestinal Diseases; Hypoglycemic Agents; Insulin; Pancreatic Diseases; pharmacological_intervention;