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Prospective randomized study for optimal insulin therapy in type 2 diabetic patients with secondary failure
BACKGROUND: The large clinical trials proved that Basal-Bolus (BB) insulin therapy was effective in the prevention of diabetic complications and their progression. However, BB therapy needs multiple insulin injections per a day. In this regard, a biphasic insulin analogue needs only twice-daily inje...
Autores principales: | , , , , , , , , , |
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Formato: | Texto |
Lenguaje: | English |
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BioMed Central
2008
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2442047/ https://www.ncbi.nlm.nih.gov/pubmed/18507868 http://dx.doi.org/10.1186/1475-2840-7-16 |
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author | Miyashita, Yumi Nishimura, Rimei Nemoto, Masami Matsudaira, Toru Kurata, Hideaki Yokota, Tamotsu Yokota, Kuninobu Tojo, Katsuyoshi Utsunomiya, Kazunori Tajima, Naoko |
author_facet | Miyashita, Yumi Nishimura, Rimei Nemoto, Masami Matsudaira, Toru Kurata, Hideaki Yokota, Tamotsu Yokota, Kuninobu Tojo, Katsuyoshi Utsunomiya, Kazunori Tajima, Naoko |
author_sort | Miyashita, Yumi |
collection | PubMed |
description | BACKGROUND: The large clinical trials proved that Basal-Bolus (BB) insulin therapy was effective in the prevention of diabetic complications and their progression. However, BB therapy needs multiple insulin injections per a day. In this regard, a biphasic insulin analogue needs only twice-daily injections, and is able to correct postprandial hyperglycemia. Therefore it may achieve the blood glucose control as same as that of BB therapy and prevent the diabetic complications including macroangiopathy. METHODS: In PROBE (Prospective, Randomized, Open, Blinded-Endpoint) design, forty-two type 2 diabetic patients (male: 73.8%, median(inter quartile range) age: 64.5(56.8~71.0)years) with secondary failure of sulfonylurea (SU) were randomly assigned to BB therapy with a thrice-daily insulin aspart and once-daily basal insulin (BB group) or to conventional therapy with a twice-daily biphasic insulin analogue (30 Mix group), and were followed up for 6 months to compare changes in HbA1c, daily glycemic profile, intima-media thickness (IMT) of carotid artery, adiponectin levels, amounts of insulin used, and QOL between the two groups. RESULTS: After 6 months, HbA1c was significantly reduced in both groups compared to baseline (30 Mix; 9.3(8.1~11.3) → 7.4(6.9~8.7)%, p < 0.01, vs BB;8.9(7.7~10.0) → 6.9(6.2~7.3)%, p < 0.01), with no significant difference between the groups in percentage change in HbA1c (30 Mix; -14.7(-32.5~-7.5)% vs BB -17.8(-30.1~-11.1)%, p = 0.32). There was a significant decrease in daily glycemic profile at all points except dinner time in both groups compared to baseline. There was a significant increase in the amount of insulin used in the 30 Mix group after treatment compared to baseline (30 Mix;0.30(0.17~0.44) → 0.39(0.31~0.42) IU/kg, p = 0.01). There was no significant difference in IMT, BMI, QOL or adiponectin levels in either group compared to baseline. CONCLUSION: Both BB and 30 mix group produced comparable reductions in HbA1c in type 2 diabetic patients with secondary failure. There was no significant change in IMT as an indicator of early atherosclerotic changes between the two groups. The basal-bolus insulin therapy may not be necessarily needed if the type 2 diabetic patients have become secondary failure. TRIAL REGISTRATION: Current Controlled Trials number, NCT00348231 |
format | Text |
id | pubmed-2442047 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2008 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-24420472008-07-01 Prospective randomized study for optimal insulin therapy in type 2 diabetic patients with secondary failure Miyashita, Yumi Nishimura, Rimei Nemoto, Masami Matsudaira, Toru Kurata, Hideaki Yokota, Tamotsu Yokota, Kuninobu Tojo, Katsuyoshi Utsunomiya, Kazunori Tajima, Naoko Cardiovasc Diabetol Original Investigation BACKGROUND: The large clinical trials proved that Basal-Bolus (BB) insulin therapy was effective in the prevention of diabetic complications and their progression. However, BB therapy needs multiple insulin injections per a day. In this regard, a biphasic insulin analogue needs only twice-daily injections, and is able to correct postprandial hyperglycemia. Therefore it may achieve the blood glucose control as same as that of BB therapy and prevent the diabetic complications including macroangiopathy. METHODS: In PROBE (Prospective, Randomized, Open, Blinded-Endpoint) design, forty-two type 2 diabetic patients (male: 73.8%, median(inter quartile range) age: 64.5(56.8~71.0)years) with secondary failure of sulfonylurea (SU) were randomly assigned to BB therapy with a thrice-daily insulin aspart and once-daily basal insulin (BB group) or to conventional therapy with a twice-daily biphasic insulin analogue (30 Mix group), and were followed up for 6 months to compare changes in HbA1c, daily glycemic profile, intima-media thickness (IMT) of carotid artery, adiponectin levels, amounts of insulin used, and QOL between the two groups. RESULTS: After 6 months, HbA1c was significantly reduced in both groups compared to baseline (30 Mix; 9.3(8.1~11.3) → 7.4(6.9~8.7)%, p < 0.01, vs BB;8.9(7.7~10.0) → 6.9(6.2~7.3)%, p < 0.01), with no significant difference between the groups in percentage change in HbA1c (30 Mix; -14.7(-32.5~-7.5)% vs BB -17.8(-30.1~-11.1)%, p = 0.32). There was a significant decrease in daily glycemic profile at all points except dinner time in both groups compared to baseline. There was a significant increase in the amount of insulin used in the 30 Mix group after treatment compared to baseline (30 Mix;0.30(0.17~0.44) → 0.39(0.31~0.42) IU/kg, p = 0.01). There was no significant difference in IMT, BMI, QOL or adiponectin levels in either group compared to baseline. CONCLUSION: Both BB and 30 mix group produced comparable reductions in HbA1c in type 2 diabetic patients with secondary failure. There was no significant change in IMT as an indicator of early atherosclerotic changes between the two groups. The basal-bolus insulin therapy may not be necessarily needed if the type 2 diabetic patients have become secondary failure. TRIAL REGISTRATION: Current Controlled Trials number, NCT00348231 BioMed Central 2008-05-29 /pmc/articles/PMC2442047/ /pubmed/18507868 http://dx.doi.org/10.1186/1475-2840-7-16 Text en Copyright © 2008 Miyashita et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( (http://creativecommons.org/licenses/by/2.0) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Investigation Miyashita, Yumi Nishimura, Rimei Nemoto, Masami Matsudaira, Toru Kurata, Hideaki Yokota, Tamotsu Yokota, Kuninobu Tojo, Katsuyoshi Utsunomiya, Kazunori Tajima, Naoko Prospective randomized study for optimal insulin therapy in type 2 diabetic patients with secondary failure |
title | Prospective randomized study for optimal insulin therapy in type 2 diabetic patients with secondary failure |
title_full | Prospective randomized study for optimal insulin therapy in type 2 diabetic patients with secondary failure |
title_fullStr | Prospective randomized study for optimal insulin therapy in type 2 diabetic patients with secondary failure |
title_full_unstemmed | Prospective randomized study for optimal insulin therapy in type 2 diabetic patients with secondary failure |
title_short | Prospective randomized study for optimal insulin therapy in type 2 diabetic patients with secondary failure |
title_sort | prospective randomized study for optimal insulin therapy in type 2 diabetic patients with secondary failure |
topic | Original Investigation |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2442047/ https://www.ncbi.nlm.nih.gov/pubmed/18507868 http://dx.doi.org/10.1186/1475-2840-7-16 |
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