Effect of Adjunct Metformin Treatment in Patients with Type-1 Diabetes and Persistent Inadequate Glycaemic Control. A Randomized StudyReport as inadecuate




Effect of Adjunct Metformin Treatment in Patients with Type-1 Diabetes and Persistent Inadequate Glycaemic Control. A Randomized Study - Download this document for free, or read online. Document in PDF available to download.

Background

Despite intensive insulin treatment, many patients with type-1 diabetes T1DM have longstanding inadequate glycaemic control. Metformin is an oral hypoglycaemic agent that improves insulin action in patients with type-2 diabetes. We investigated the effect of a one-year treatment with metformin versus placebo in patients with T1DM and persistent poor glycaemic control.

Methodology-Principal Findings

One hundred patients with T1DM, preserved hypoglycaemic awareness and HaemoglobinA1c HbA1c ≥8.5% during the year before enrolment entered a one-month run-in on placebo treatment. Thereafter, patients were randomized baseline to treatment with either metformin 1 g twice daily or placebo for 12 months double-masked. Patients continued ongoing insulin therapy and their usual outpatient clinical care. The primary outcome measure was change in HbA1c after one year of treatment. At enrolment, mean standard deviation HbA1c was 9.48% 0.99 for the metformin group n = 49 and 9.60% 0.86 for the placebo group n = 51. Mean 95% confidence interval baseline-adjusted differences after 12 months with metformin n = 48 versus placebo n = 50 were: HbA1c, 0.13% −0.19; 0.44, p = 0.422; Total daily insulin dose, −5.7 U-day −8.6; −2.9, p<0.001; body weight, −1.74 kg −3.32; −0.17, p = 0.030. Minor and overall major hypoglycaemia was not significantly different between treatments. Treatments were well tolerated.

Conclusions-Significance

In patients with poorly controlled T1DM, adjunct metformin therapy did not provide any improvement of glycaemic control after one year. Nevertheless, adjunct metformin treatment was associated with sustained reductions of insulin dose and body weight. Further investigations into the potential cardiovascular-protective effects of metformin therapy in patients with T1DM are warranted.

Trial Registration

ClinicalTrials.gov NCT00118937



Author: Søren Søgaard Lund , Lise Tarnow, Anne Sofie Astrup, Peter Hovind, Peter Karl Jacobsen, Amra Ciric Alibegovic, Ida Parving, Lot

Source: http://plos.srce.hr/



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