Published Studies Related to Apidra (Insulin Glulisine)
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 glulisine compared to insulin aspart and to insulin lispro administered by continuous subcutaneous insulin infusion in patients with type 1 diabetes: a randomized controlled trial. [2011.06]
BACKGROUND: In a previous pilot study comparing insulin glulisine (GLU) with insulin aspart (ASP) administered by continuous subcutaneous insulin infusion (CSII), GLU-treated patients did show a trend toward fewer catheter occlusions compared with ASP-treated patients. Here we performed a randomized open-label, three-way crossover, controlled multicenter study comparing GLU with ASP and insulin lispro (LIS)... CONCLUSIONS: GLU was not superior to ASP and LIS with no significant difference seen among GLU, ASP, and LIS in CSII use with respect to unexplained hyperglycemia and/or perceived catheter set occlusion. GLU was associated with a higher frequency of symptomatic hypoglycemia, possibly because of slight overdosing, as previous trials suggested lower insulin requirements when GLU is initiated in type 1 diabetes.
Effects of insulin and oral anti-diabetic agents on glucose metabolism, vascular dysfunction and skeletal muscle inflammation in type 2 diabetic subjects. [2011.05]
BACKGROUND: To test potential differences between the actions of anti-diabetic medications, we examined the effects of oral hypoglycaemic agents versus glargine-apidra insulin therapy in T2DM... CONCLUSIONS: Oral hypoglycaemic agents and insulin therapy treated patients achieved adequate glycemic control and the effects on circulating and muscle inflammatory biomarkers were similar, but only oral hypoglycaemic agents improved insulin sensitivity, vascular function and carotid intimal media thickness. These findings in a small sample suggest that the use of oral hypoglycaemic agents provides additional benefits to patients with T2DM. Copyright (c) 2011 John Wiley & Sons, Ltd.
A stepwise approach to insulin therapy in patients with type 2 diabetes mellitus and basal insulin treatment failure. [2011.05]
OBJECTIVE: To determine whether 1 or 2 preprandial injections before the meals of greatest glycemic impact can be as effective as 3 preprandial injections in patients with type 2 diabetes mellitus and basal insulin treatment failure... CONCLUSION: This study provides evidence that initiation of prandial insulin in a simplified stepwise approach is an effective alternative to the current routine 3 preprandial injection basal-bolus approach.
Comparable efficacy and safety of insulin glulisine and insulin lispro when given as part of a Basal-bolus insulin regimen in a 26-week trial in pediatric patients with type 1 diabetes. [2011.03]
BACKGROUND: We compared the efficacy and safety of insulin glulisine with insulin lispro as part of a basal-bolus regimen in children and adolescents with type 1 diabetes... CONCLUSIONS: Glulisine was as effective as lispro in baseline-to-endpoint A1c change, and both treatments were similarly well tolerated.
Clinical Trials Related to Apidra (Insulin Glulisine)
Treatment Satisfaction of Insulin Glargine Plus Insulin Apidra Compared With NPH Insulin Plus Insulin Apidra in Recently Diagnosed Type 1 Diabetes Children and Adolescents [Recruiting]
A randomized, crossover, open study in order to compare treatment satisfaction with insulin
Glargine plus insulin Apidra Vs NPH insulin plus insulin Apidra in newly diagnosed children
and adolescents with type 1 diabetes.
The study will include two consecutive periods: 2 weeks run in period and 24 weeks
intervention period, divided into two separate treatment periods of 12 weeks. According to
randomization, each patient will be treated consecutively with both treatment arms: 12 weeks
with insulin Glargine and than 12 weeks with NPH insulin or 12 weeks with insulin NPH ad
than 12 weeks with insulin Glargine. Patients will complete DTSQ (Diabetes Treatment
Satisfaction Questionnaire) at months 0, 12 and 24 weeks, before and at the end of each
Insulin Glulisine Administered Pre-Meal Versus Post-Meal in Adult Subjects With Type 2 Diabetes Mellitus Receiving Insulin Glargine as Basal Insulin [Completed]
The purpose of this study is to compare the change in weight from baseline to study week 52
in the per-protocol population of pre-meal insulin glulisine (Apidra) versus post-meal
Apidra, in patients receiving insulin glargine (Lantus) as basal insulin.
The Effect of Insulin Glulisine Compared With Insulin Aspart on Breakfast Post Prandial Glucose Levels in Prepubertal Children [Recruiting]
To determine whether insulin glulisine decreases the breakfast post prandial glycemic
excursion in comparison to insulin aspart.
BASAAL PLUS - Better Acceptance of Single Injection Apidra Added to Once Daily Lantus Versus Twice Daily Premixed Insulin in Real Life Use Setting [Recruiting]
To demonstrate non-inferiority of once daily injection of insulin glargine (Lantus) plus one
injection of mealtime insulin glulisine (Apidra) at the main meal versus twice daily
premixed insulin (NovoMix 30/70) based on the reduction of HbA1c percentage from baseline to
- To determine treatment satisfaction (DTSQs/Diabetes Treatment Questionnaire - Status,
DTSQc/ Diabetes Treatment Questionnaire - change and ITSQ/Insulin Treatment
- To determine the mean HbA1c, FBG (Fasting Blood Glucose), prandial BG (Blood Glucose)
and proportion of patients with a HbA1c <7%
- To determine the effect on adverse events (e. g. symptomatic hypoglycemic events, weight
gain and injection site reactions)
- To determine the total insulin dose, average insulin glargine, insulin glulisine and
premixed insulin dosages.
Intensive Insulin Glulisine Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin and Oral Glucose-lowering Drugs [Recruiting]
To evaluate the efficacy of an intensive insulin regimen with insulin glargine and insulin
glulisine in terms of change in Hemoglobin A1c (HbA1c) level from week 12 (visit 7) to week
24 (visit 10).
1. Percentage of patients with HbA1c < 7% at week 24.
2. Percentage of patients with HbA1c < 7% and no symptomatic nocturnal hypoglycemia event
at week 24.
3. Fasting Plasma Glucose (FPG) and 7-point Self Monitoring of Blood Glucose (SMBG) at
week 0, week 12 and week 24.
4. Doses of insulin glargine and insulin glulisine: the daily dose (U) and the daily dose
/ kg (U/kg) will be calculated at week 24.
5. Systolic and diastolic blood pressure, heart rate, weight change will be measured at
week 0, week 12 and week 24.
6. Number of patients suffering hypoglycemias (asymptomatic, symptomatic, nocturnal
symptomatic, severe and nocturnal severe) will be evaluated during the treatment
period. 7-Adverse events.
Reports of Suspected Apidra (Insulin Glulisine) Side Effects
Blood Glucose Increased (77),
Product Quality Issue (36),
Blood Glucose Decreased (22),
Visual Impairment (22),
Diabetic Ketoacidosis (21),
Confusional State (16),
Drug Ineffective (16), more >>