Addition of Basal Insulin to Oral Antidiabetic Agents in Patients with Inadequately Controlled Type 2 Diabetes Leads to Improved HbA1c Levels: Metabolic Control, Frequency of Hypoglycemia, and Insulin Titration Analysis as Results of a Prospective Observational Study (BALI Study)

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064203%3A_____%2F19%3A10394337" target="_blank" >RIV/00064203:_____/19:10394337 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11130/19:10394337

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=3ry5KqpyvV" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=3ry5KqpyvV</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1007/s13300-019-0584-8" target="_blank" >10.1007/s13300-019-0584-8</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Addition of Basal Insulin to Oral Antidiabetic Agents in Patients with Inadequately Controlled Type 2 Diabetes Leads to Improved HbA1c Levels: Metabolic Control, Frequency of Hypoglycemia, and Insulin Titration Analysis as Results of a Prospective Observational Study (BALI Study)

Popis výsledku v původním jazyce

IntroductionDespite the continuously growing number of therapeutic options for patients with type 2 diabetes mellitus (T2DM), a large percentage of these individuals fail to achieve their glycated hemoglobin (HbA1c) target. The aim of this study was to determine the change in metabolic control in insulin-naive T2DM patients inadequately controlled with oral antidiabetic drugs (OADs) at 6 months after initiating basal insulin treatment as add-on to existing OADs.MethodsThis was a non-interventional prospective study conducted from June 2013 to December 2014 in 137 centers in the Czech Republic under routine clinical practice conditions. Adult patients whose diabetes was uncontrolled on their current OAD treatment (HbA1c 53 mmol/mol; Diabetes Control and Complications Trial [DCCT]-HbA1c 7%) and whose physician had decided to initiate treatment on a basal insulin regimen were documented over a 6-month period beginning from the time of initiation of basal insulin treatment.ResultsOverall, 1426 T2DM patients were included in the study, of whom 53% were male. The mean age of the study population was 63.8 10.1 years, mean body mass index was 31.5 5.3 kg/m(2), and mean duration of diabetes was 10.2 +/- 5.3 years. At the 6-month follow-up, the target HbA1c level of 53 mmol/mol (DCCT &lt; 7%) was achieved by 18% of patients. The mean HbA1c overall had decreased from 77.2 +/- 15.1 mmol/mol (DCCT 9.21 +/- 1.38%) at baseline to 63.2 +/- 12.5 mmol/mol (DCCT 7.93 +/- 1.14 %) at the 6-month follow-up. This difference was significant at p &lt; 0.001. The largest mean reduction in HbA1c, i.e., 20.9 mmol/mol (DCCT 2.4 %) was observed in the group of patients with a baseline HbA1c of 9%. The mean daily basal insulin dose at 6 months was 18.8 +/- 8.9 units. Symptomatic hypoglycemia was reported in 12.3% of patients, of those only one patient (0.1%) suffered from severe hypoglycemia.Conclusion The addition of basal insulin to the therapeutic regimen of insulin-naive T2DM on OAD treatment resulted in an improved metabolic control of diabetes after 6 months of treatment. However, most patients did not achieve their HbA1c target, probably also due to inadequate titration of basal insulin.FundingSanofi, Czech Republic.

Název v anglickém jazyce

Addition of Basal Insulin to Oral Antidiabetic Agents in Patients with Inadequately Controlled Type 2 Diabetes Leads to Improved HbA1c Levels: Metabolic Control, Frequency of Hypoglycemia, and Insulin Titration Analysis as Results of a Prospective Observational Study (BALI Study)

Popis výsledku anglicky

IntroductionDespite the continuously growing number of therapeutic options for patients with type 2 diabetes mellitus (T2DM), a large percentage of these individuals fail to achieve their glycated hemoglobin (HbA1c) target. The aim of this study was to determine the change in metabolic control in insulin-naive T2DM patients inadequately controlled with oral antidiabetic drugs (OADs) at 6 months after initiating basal insulin treatment as add-on to existing OADs.MethodsThis was a non-interventional prospective study conducted from June 2013 to December 2014 in 137 centers in the Czech Republic under routine clinical practice conditions. Adult patients whose diabetes was uncontrolled on their current OAD treatment (HbA1c 53 mmol/mol; Diabetes Control and Complications Trial [DCCT]-HbA1c 7%) and whose physician had decided to initiate treatment on a basal insulin regimen were documented over a 6-month period beginning from the time of initiation of basal insulin treatment.ResultsOverall, 1426 T2DM patients were included in the study, of whom 53% were male. The mean age of the study population was 63.8 10.1 years, mean body mass index was 31.5 5.3 kg/m(2), and mean duration of diabetes was 10.2 +/- 5.3 years. At the 6-month follow-up, the target HbA1c level of 53 mmol/mol (DCCT &lt; 7%) was achieved by 18% of patients. The mean HbA1c overall had decreased from 77.2 +/- 15.1 mmol/mol (DCCT 9.21 +/- 1.38%) at baseline to 63.2 +/- 12.5 mmol/mol (DCCT 7.93 +/- 1.14 %) at the 6-month follow-up. This difference was significant at p &lt; 0.001. The largest mean reduction in HbA1c, i.e., 20.9 mmol/mol (DCCT 2.4 %) was observed in the group of patients with a baseline HbA1c of 9%. The mean daily basal insulin dose at 6 months was 18.8 +/- 8.9 units. Symptomatic hypoglycemia was reported in 12.3% of patients, of those only one patient (0.1%) suffered from severe hypoglycemia.Conclusion The addition of basal insulin to the therapeutic regimen of insulin-naive T2DM on OAD treatment resulted in an improved metabolic control of diabetes after 6 months of treatment. However, most patients did not achieve their HbA1c target, probably also due to inadequate titration of basal insulin.FundingSanofi, Czech Republic.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30202 - Endocrinology and metabolism (including diabetes, hormones)

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2019

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Diabetes Therapy

ISSN

1869-6953

e-ISSN

—

Svazek periodika

10

Číslo periodika v rámci svazku

2

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

10

Strana od-do

663-672

Kód UT WoS článku

000462919600024

EID výsledku v databázi Scopus

2-s2.0-85065803107