NEWS HIGHLIGHTS
Published Studies Related to Exubera (Insulin Inhalation)
Glycemic exposure is affected favorably by inhaled human insulin (Exubera) as compared with subcutaneous insulin glargine (Lantus) in patients with type 2 diabetes. [2009.05]
BACKGROUND: The objective was to compare the effects on glycemia of adding either inhaled human insulin (Exubera [EXU] [insulin human (recombinant DNA origin) inhalational powder]) or subcutaneous insulin glargine (GLA) to the treatment regimens of patients with type 2 diabetes uncontrolled with oral antidiabetic drugs... CONCLUSIONS: Prandial insulin therapy with EXU, using a higher daily insulin dose, reduces total daily glucose exposure--in particular postmeal glycemia--more effectively than a basal insulin analog.
Safety and efficacy of inhaled insulin (AERx iDMS) compared with subcutaneous insulin therapy in patients with Type 1 diabetes: 1-year data from a randomized, parallel group trial. [2009.03]
AIMS: Assessment of the long-term safety and efficacy of liquid inhaled insulin via AERx insulin Diabetes Management System (iDMS) in a basal/bolus treatment regimen of adults with Type 1 diabetes... CONCLUSIONS: The safety and efficacy results in this trial were similar to those reported with other inhaled insulins; however, inhaled insulin using AERx iDMS requires further optimization to reduce nocturnal hypoglycaemia before it has comparable safety and efficacy to s.c. insulin aspart.
Safety and efficacy of inhaled human insulin (Exubera) during discontinuation and readministration of therapy in adults with type 1 diabetes: A 3-year randomized controlled trial. [2008.11]
OBJECTIVE: To assess pulmonary safety during discontinuation and readministration of inhaled human insulin (EXU; Exubera((R)) insulin human [rDNA origin]) Inhalation Powder) therapy in adults with type 1 diabetes... CONCLUSIONS: FEV(1) and DL(CO) changes observed during discontinuation and readministration of EXU therapy are consistent with a reversible, non-progressive and non-pathological effect on lung function. EXU readministration is not associated with an augmented IAb response.
Efficacy and safety of Technosphere inhaled insulin compared with Technosphere powder placebo in insulin-naive type 2 diabetes suboptimally controlled with oral agents. [2008.11]
CONCLUSIONS: Technosphere insulin was well tolerated and demonstrated significant improvement in glycemic control with clinically meaningful reductions in A1C levels and postprandial glucose concentrations after 12 weeks of treatment.
Safety and efficacy of inhaled human insulin (Exubera((R))) during discontinuation and readministration of therapy in adults with type 1 diabetes: A 3-year randomized controlled trial. [2008.09.26]
OBJECTIVE: To assess pulmonary safety during discontinuation and readministration of inhaled human insulin (EXU; Exubera((R)) insulin human [rDNA origin]) Inhalation Powder) therapy in adults with type 1 diabetes... CONCLUSIONS: FEV(1) and DL(CO) changes observed during discontinuation and readministration of EXU therapy are consistent with a reversible, non-progressive and non-pathological effect on lung function. EXU readministration is not associated with an augmented IAb response.
Clinical Trials Related to Exubera (Insulin Inhalation)
Effect of Insulin Glulisine Compared to Insulin Aspart and Insulin Lispro When Administered by Continuous Subcutaneous Insulin Infusion (CSII) on Specific Pump Parameters in Patient With Type 1 Diabetes Mellitus [Recruiting]
Primary: To assess the superiority of insulin glulisine over insulin aspart and insulin
lispro administered by external pump in term of unexplained hyperglycemia and/or infusion set
occlusion.
Secondary:
To compare insulin glulisine, insulin aspart and insulin lispro on:
- Unexplained hyperglycemia
- Infusion set occlusion
- HbA1c, hypoglycemic episodes, 7-point blood glucose profiles, episodes of ketosis and
ketoacidosis
- Insulin doses (total, basal, bolus)
- Time to change the infusion set.
- Site infection, site inflammation / erythema, pruritis and isolated pain at injection
site
- Overall safety: incidence of adverse events
- Change in body weight
Feasibility Study of the Effect of Intra-Dermal Insulin Injection on Blood Glucose Levels After Eating [Recruiting]
This study is to determine the effect of intra-dermal (ID) administration of regular and of
rapid-acting insulin, before eating, on blood glucose levels for several hours after a
standard meal (a mixed, liquid meal). Insulin will also be given normally, subcutaneously,
for control or comparison purposes. The hypothesis or expectation is that ID insulin will
work more quickly and control blood glucose levels better than SC injection.
Insulin Detemir Versus NPH Insulin In Hospitalized Patients With Diabetes [Recruiting]
High blood glucose levels in hospitalized patients with diabetes are associated with
increased risk of medical complications. Improved glucose control with insulin injections
may improve clinical outcome and prevent some of the hospital complications. It is not known;
however, what is the best insulin regimen in hospitalized patients. Recently, the use of
basal/bolus insulin therapy with detemir (LevemirĀ®) and rapid-acting insulin (lispro, aspart,
glulisine) has been shown to facilitate outpatient glycemic control with lower rate of
hypoglycemic (low blood sugar) events in patients with diabetes. In this study, we will
determine the efficacy and safety of the combination of detemir and aspart insulin in the
inpatient management of subjects with diabetes. We hypothesize that in patients with type 2
diabetes admitted to general medicine wards, treatment with insulin detemir once daily plus
insulin aspart before meals will allow better glycemic control and lower rate of hypoglycemic
events than treatment with twice a day NPH plus regular insulin before meals. Detemir is a
long-acting insulin which is given subcutaneously (under the skin) once daily. Aspart is a
rapid-acting insulin which is given subcutaneously several times a day and frequently before
meals. Detemir and aspart insulins are approved for use in the treatment of patients with
diabetes by the FDA.
This investigator-initiated research will be conducted at Grady Memorial Hospital, Atlanta
and at Rush University Medical Center, Chicago, IL. Dr. Umpierrez designed the study and
will serve as principal investigator. A total of 65 patients will be recruited at Grady and
65 patients at the Rush University Medical Center, Chicago, IL.
Effect of Insulin Detemir on Use of Energy in Type 1 Diabetes [Recruiting]
This trial is conducted in Europe.
The purpose of this trial is to investigate if there is any change in the mechanism of energy
expenditure (i. e. the way in which energy is used) in patients with type 1 diabetes, whilst
taking two different, commercially available insulins for the treatment of their diabetes.
U-500R Insulin In Type 2 Diabetes With Severe Insulin Resistance Via Omnipod [Recruiting]
Patients with Type 2 diabetes and severe insulin resistance with very large insulin
requirements who have failed all previous insulin regimens using nonconcentrated forms of
insulin (U100 insulin formulations) will be able to control their blood glucose levels using
5X concentrated insulin (U500 regular insulin) when it is infused continuously subcutaneously
via insulin pump.
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