PMID- 24073952
OWN - NLM
STAT- MEDLINE
DCOM- 20151106
LR  - 20221207
IS  - 0042-773X (Print)
IS  - 0042-773X (Linking)
VI  - 59
IP  - 9
DP  - 2013 Sep
TI  - [RESOLUTE Study in the Czech Republic: insulin glargine improves the compensation 
      of type 2 diabetes in patients with unsatisfactory results of therapy with a 
      combination of insulin detemir and oral antidiabetics. Results of the 
      nonintervention RESOLUTE Project in the Czech Republic].
PG  - 800-6
AB  - INTRODUCTION: The RESOLUTE was a multinational, non interventional, 6 month 
      prospective observational project evaluating in clinical practice, whether 
      patients with type 2 diabetes mellitus (T2DM) inadequately controlled with 
      detemir in combination with oral antidiabetic drugs (OADs) may benefit from 
      switching to glargine. In Czech Republic 200 patients, for whom the participating 
      physician according to their own consideration, had decided to prescribe insulin 
      glargine in replacement of insulin detemir, were included in this project. 
      OBJECTIVES: The primary endpoint was to assess the change in HbA1c over the 
      6- month period in T2DM patients treated with insulin glargin after switch from 
      insulin detemir. Secondary endpoints included the evaluation of the change in 
      fasting plasma glucose, insulin dose, body weight over the 6-month period after 
      starting insulin glargine , the evaluation of the number of hypoglycemia during 
      the last month of therapy which each basal insulin and the frequency of adverse 
      events (AE) during treatment with insulin glargine. RESULTS: Insulin glargine 
      therapy resulted in a statistically significant improvement in compensation of 
      diabetes characterized by a mean HbA1c decrease of about 0.82 (+/- 0.93) % (p < 
      0.001) and a mean decrease of recorded fasting glycemia about 1.91 (+/- 2.81) 
      mmol/ l (p < 0.001). No significant change in the mean body weight was recorded 
      du-ring study [+0.12 (+/- 2.98) kg; p = NS]. The mean daily insulin glargine dose 
      used at the end of the observation increased in comparison with last mean daily 
      dose of insulin detemir [+2.99 (+/- 7.54) U; p < 0.001]. The improvement in 
      glycemic control was accompanied by low risk of hypoglycemia. The percentage of 
      patients with documented symptomatic (5.0%), nocturnal (2.5%) and severe (0%) 
      hypoglycemia in the last month of glargine therapy was consistently lower 
      compared with the last month of previous treatment with detemir (14.6%, 9.5% and 
      2.5%, respectively). Other adverse events were reported in 3.0% of patients on 
      glargine therapy. No adverse events were considered as adverse event related to 
      insulin glargin treatment. No serious adverse or no serious adverse events 
      leading to treatment discontinuation or death were documented during the course 
      of the study. CONCLUSION: Under reallife conditions, switching from insulin 
      detemir to once daily insulin glargine in poorly controlled T2DM patients 
      resulted in clinically relevant improvements in glycemic control without an 
      increase in weight and hypoglycemia risk.
FAU - Kvapil, M
AU  - Kvapil M
LA  - cze
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
TT  - Studie RESOLUTE v Ceske republice: inzulin glargin zlepsuje kompenzaci diabetu 2. 
      typu u pacientu s dosud neuspokojivym vysledkem terapie kombinaci inzulin detemir 
      a peroralni antidiabetika. Vysledky neintervencniho projektu RESOLUTE v Ceske 
      republice.
PL  - Czech Republic
TA  - Vnitr Lek
JT  - Vnitrni lekarstvi
JID - 0413602
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin, Long-Acting)
RN  - 2ZM8CX04RZ (Insulin Glargine)
RN  - 4FT78T86XV (Insulin Detemir)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Blood Glucose/analysis
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Dose-Response Relationship, Drug
MH  - *Drug Substitution
MH  - Female
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemic Agents/*therapeutic use
MH  - Insulin Detemir
MH  - Insulin Glargine
MH  - Insulin, Long-Acting/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
EDAT- 2013/10/01 06:00
MHDA- 2015/11/07 06:00
CRDT- 2013/10/01 06:00
PHST- 2013/10/01 06:00 [entrez]
PHST- 2013/10/01 06:00 [pubmed]
PHST- 2015/11/07 06:00 [medline]
AID - 41529 [pii]
PST - ppublish
SO  - Vnitr Lek. 2013 Sep;59(9):800-6.