NEWS HIGHLIGHTS
Published Studies Related to Lantus (Insulin Glargine)
Influence of insulin and glargine on outgrowth and number of circulating
endothelial progenitor cells in type 2 diabetes patients: a partially
double-blind, randomized, three-arm unicenter study. [2014]
aiming at similar glucose control between the groups... CONCLUSION: The study shows that a 4-month treatment with add-on insulin
Slow-release insulin in cystic fibrosis patients with glucose intolerance: a randomized clinical trial. [2011.11.08]
Minicucci L, Haupt M, Casciaro R, De Alessandri A, Bagnasco F, Lucidi V, Notarnicola S, Lorini R, Bertasi S, Raia V, Cialdella P, Haupt R. Slow-release insulin in cystic fibrosis patients with glucose intolerance: a randomized clinical trial... Further studies are necessary to test glargine at higher dosage and for a longer follow-up period.
Effects of initiation and titration of a single pre-prandial dose of insulin glulisine while continuing titrated insulin glargine in type 2 diabetes: a 6-month 'proof-of-concept' study. [2011.11]
AIM: Stepwise intensification of insulin treatment to match the progressive decline of endogenous insulin secretion has been shown to be an effective management strategy in type 2 diabetes mellitus (T2DM). The efficacy of initiating and titrating a single bolus dose of insulin glulisine to baseline insulin glargine plus oral hypoglycaemic agents (OHAs) was investigated... CONCLUSIONS: In people with T2DM inadequately controlled on basal insulin plus OHAs, adding a single injection of insulin glulisine prior to the main meal significantly improves glucose control without undesired side effects. (c) 2011 Blackwell Publishing Ltd.
Insulin injections in relation to meals in the hospital medicine ward: comparison of 2 protocols. [2011.09.01]
OBJECTIVE: To investigate whether changing the prandial regular insulin to rapid-acting insulin analogue in hospital medicine wards improves the timing of insulin delivery in relation to meals and improves patient safety and glucose control... CONCLUSIONS: The use of prandial insulin analogues in medicine wards allows better timing with meals than regular insulin and results in better hypoglycemic outcomes. Higher rates of hyperglycemia with prandial analogues may need adjustment in insulin doses.
Meal-induced increases in C-reactive protein, interleukin-6 and tumour necrosis factor alpha are attenuated by prandial + basal insulin in patients with Type 2 diabetes. [2011.09]
AIM: To determine if a regimen with prandial + basal insulin compared with basal insulin attenuates post-meal inflammatory and glycative biomarkers in patients with Type 2 diabetes... CONCLUSIONS: Controlling post-meal hyperglycaemia with prandial + basal insulin in patients with Type 2 diabetes attenuates meal-induced increases in high-sensitivity C-reactive protein, interleukin-6 and tumour necrosis factor alpha compared with basal insulin. The rise in post-meal glucose, but not triglycerides, significantly correlated with the rise in post-meal inflammatory and glycative biomarkers. (c) 2011 The Authors. Diabetic Medicine (c) 2011 Diabetes UK.
Clinical Trials Related to Lantus (Insulin Glargine)
Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin [Completed]
The primary objective of this study is to determine the optimal dose of glargine insulin
when converting from intravenous short-acting continuous insulin infusions in surgical and
intensive care unit patients using a prospective, controlled, parallel group, randomized
study design.
Note: Lantus insulin is the proprietary name for glargine insulin.
Insulin Glargine "All to Target" Trial [Completed]
The primary objectives were:
- To demonstrate the superiority of Lantus plus stepwise addition of mealtime Apidra®
(Lantus/Apidra-3) versus twice-daily Premixed insulin based on the proportion of
patients achieving target glycemic control (as measured by hemoglobin A1c [HbA1c]
<7. 0%) at Week 60
- To demonstrate the noninferiority of Lantus plus addition of 1 mealtime Apidra
injection (Lantus/Apidra-1) versus twice-daily Premixed insulin based on the reduction
from Baseline to Week 60 in HbA1c
Glycemic Effects of Morning Only, Evening Only or Twice Daily Insulin Glargine in Patients With Type 1 Diabetes [Not yet recruiting]
This research is a prospective, randomized, cross-over study that is being done to compare
the effect of morning only, evening only and twice daily insulin glargine (Lantus®) on
hypoglycemia (blood glucose level <70 mg/dL) as measured by continuous glucose monitoring
(CGM) in patients with type 1 diabetes.
The Effect of Exenatide Compared to Lantus Insulin on Vascular Function in Type 2 Diabetes [Completed]
The main goals of the study are to evaluate the effect of Exenatide on endothelial-dependent
vasodilation, as measured by flow mediated dilation (FMD), to evaluate the effect on
endothelial-independent vasodilation, as measured by nitroglycerin (TNG) response, and to
evaluate the effect on arterial stiffness, as measured by pulse wave analysis (PWA). We
will also measure the effects on various markers of endothelial function, subclinical
inflammation, fibrinolysis, and oxidative stress. The control group for the study will
receive Lantus insulin, with a goal of similar glycemic control between the treatment and
control groups.
Specific Aims
We will test the following hypotheses:
1. Treatment of patients with type 2 diabetes who are inadequately controlled by
monotherapy with a Sulfonylurea (SU) or Metformin, or on combination therapy of a SU
and Metformin with Exenatide (GLP-1 mimetic) will result in improved endothelial
dependent vasodilation, as measured by FMD, as compared to the control group, who will
be treated with Lantus insulin to achieve comparable HbA1c levels.
2. Treatment with Exenatide (GLP-1 mimetic) will result in improved arterial stiffness, as
measured by AI by PWA, as compared to the control group, who will be treated with
Lantus insulin to achieve comparable HbA1c levels.
3. Endothelial dependent vasodilation, as measured by FMD, and arterial stiffness, as
measured by AI, measured in the postprandial state (following a standard test meal)
will be improved following treatment with Exenatide as compared to treatment with once
daily basal insulin (Lantus).
4. Treatment will result in no improvement in endothelial-independent vasodilation, as
measured by a response to TNG, as compared to the control group, who will be treated
with Lantus insulin to achieve comparable HbA1c levels.
5. Treatment with Exenatide, compared with treatment with Lantus, will result in a
reduction in various plasma markers of inflammation (CRP, TNFA, IL6), endothelial
activation (ICAM, VCAM, endothelin 1), fibrinolysis (PAI-1 protein, PAI-1 activity),
and oxidative stress (FOX2).
Insulin Glargine in Type I Diabetes Mellitus> Main Study "AT.LANTUS": A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar. Sub-study: "HALT"(Hypoglycaemia Avoidance With Lantus Trial) [Completed]
Primary objective:
AT. LANTUS main study*
- To determine the optimal treatment algorithm for insulin glargine based on the
incidence of severe hypoglycaemia.(*Target Number of patients for the main study: 2346)
HALT Sub-study**
- To test the hypothesis that titration regimens involving insulin glargine are
associated with changes in the rate of symptomatic hypoglycaemic episodes together with
changes in Fear of Hypoglycaemia as measured by the HFS-98 Questionnaire in Type I
diabetes.(**Target Number of patients for the Sub-study: 250)
Secondary objectives:
AT. LANTUS main study
To determine:
- the incidence of symptomatic, asymptomatic and nocturnal hypoglycaemia with each
treatment regimen
- the difference in glycemic control as measured by HbA1c and fasting blood glucose with
each treatment regimen
- the difference in glycemic control as measured by HbA1c and fasting blood glucose
between baseline and end of treatment
- the safety on the use of insulin glargine in each treatment algorithm
- the change in subject weight with each treatment regimen
- the change in insulin doses with each treatment regimen
- the change in Diabetes Treatment Satisfaction (Diabetes Treatment Satisfaction
Questionnaire, sub-study only) with each treatment regimen
HALT Sub-study (baseline to study end)
- To estimate the relationship between change in HbA1c and incidence of hypoglycaemia
- To examine the effect of insulin glargine on Quality of Life (EQ-5D) in relation to
incidence of hypoglycaemia
- To examine the effect of insulin glargine on the Hospital Anxiety and Depression Scale
(HADS) in relation to the incidence of hypoglycaemia
- To examine the use of the Prescription Plan versus standard management (no Prescription
Plan)
Reports of Suspected Lantus (Insulin Glargine) Side Effects
Device Malfunction (462),
Blood Glucose Increased (396),
Product Quality Issue (272),
Hyperglycaemia (254),
Hypoglycaemia (240),
Cerebrovascular Accident (109),
Death (103),
Blood Glucose Decreased (101),
Fall (90),
Renal Failure (90), more >>
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