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Effect of Adjunct Metformin Treatment in Patients with Type-1 Diabetes and Persistent Inadequate Glycaemic Control. A Randomized Study
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 m...
Autores principales: | , , , , , , , , , , , |
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Formato: | Texto |
Lenguaje: | English |
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Public Library of Science
2008
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2566605/ https://www.ncbi.nlm.nih.gov/pubmed/18852875 http://dx.doi.org/10.1371/journal.pone.0003363 |
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author | Lund, Søren Søgaard Tarnow, Lise Astrup, Anne Sofie Hovind, Peter Jacobsen, Peter Karl Alibegovic, Amra Ciric Parving, Ida Pietraszek, Lotte Frandsen, Merete Rossing, Peter Parving, Hans-Henrik Vaag, Allan Arthur |
author_facet | Lund, Søren Søgaard Tarnow, Lise Astrup, Anne Sofie Hovind, Peter Jacobsen, Peter Karl Alibegovic, Amra Ciric Parving, Ida Pietraszek, Lotte Frandsen, Merete Rossing, Peter Parving, Hans-Henrik Vaag, Allan Arthur |
author_sort | Lund, Søren Søgaard |
collection | PubMed |
description | 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 HaemoglobinA(1c) (HbA(1c)) ≥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 HbA(1c) after one year of treatment. At enrolment, mean (standard deviation) HbA(1c) 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: HbA(1c), 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 |
format | Text |
id | pubmed-2566605 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2008 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-25666052008-10-11 Effect of Adjunct Metformin Treatment in Patients with Type-1 Diabetes and Persistent Inadequate Glycaemic Control. A Randomized Study Lund, Søren Søgaard Tarnow, Lise Astrup, Anne Sofie Hovind, Peter Jacobsen, Peter Karl Alibegovic, Amra Ciric Parving, Ida Pietraszek, Lotte Frandsen, Merete Rossing, Peter Parving, Hans-Henrik Vaag, Allan Arthur PLoS One Research Article 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 HaemoglobinA(1c) (HbA(1c)) ≥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 HbA(1c) after one year of treatment. At enrolment, mean (standard deviation) HbA(1c) 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: HbA(1c), 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 Public Library of Science 2008-10-09 /pmc/articles/PMC2566605/ /pubmed/18852875 http://dx.doi.org/10.1371/journal.pone.0003363 Text en Lund et al. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited. |
spellingShingle | Research Article Lund, Søren Søgaard Tarnow, Lise Astrup, Anne Sofie Hovind, Peter Jacobsen, Peter Karl Alibegovic, Amra Ciric Parving, Ida Pietraszek, Lotte Frandsen, Merete Rossing, Peter Parving, Hans-Henrik Vaag, Allan Arthur Effect of Adjunct Metformin Treatment in Patients with Type-1 Diabetes and Persistent Inadequate Glycaemic Control. A Randomized Study |
title | Effect of Adjunct Metformin Treatment in Patients with Type-1 Diabetes and Persistent Inadequate Glycaemic Control. A Randomized Study |
title_full | Effect of Adjunct Metformin Treatment in Patients with Type-1 Diabetes and Persistent Inadequate Glycaemic Control. A Randomized Study |
title_fullStr | Effect of Adjunct Metformin Treatment in Patients with Type-1 Diabetes and Persistent Inadequate Glycaemic Control. A Randomized Study |
title_full_unstemmed | Effect of Adjunct Metformin Treatment in Patients with Type-1 Diabetes and Persistent Inadequate Glycaemic Control. A Randomized Study |
title_short | Effect of Adjunct Metformin Treatment in Patients with Type-1 Diabetes and Persistent Inadequate Glycaemic Control. A Randomized Study |
title_sort | effect of adjunct metformin treatment in patients with type-1 diabetes and persistent inadequate glycaemic control. a randomized study |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2566605/ https://www.ncbi.nlm.nih.gov/pubmed/18852875 http://dx.doi.org/10.1371/journal.pone.0003363 |
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