Advertisement

Topics

BASAAL PLUS - Better Acceptance of Single Injection Apidra Added to Once Daily Lantus Versus Twice Daily Premixed Insulin in Real Life Use Setting

2014-08-27 03:15:30 | BioPortfolio

Summary

Primary Objective:

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 endpoint.

Secondary Objective:

- To determine treatment satisfaction (DTSQs/Diabetes Treatment Questionnaire - Status, DTSQc/ Diabetes Treatment Questionnaire - change and ITSQ/Insulin Treatment Satisfaction Questionnaire)

- 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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Diabetes Mellitus, Type 2

Intervention

Insulin glulisine, Insulin glargine, Premixed insulin (Insulin Aspart 30/70 )

Location

Sanofi-Aventis Administrative Office
Gouda
Netherlands

Status

Recruiting

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:30-0400

Clinical Trials [3293 Associated Clinical Trials listed on BioPortfolio]

Comparison of Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30 and Insulin Glargine and Insulin Glulisine Therapy in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this clinical trial is to compare the 24-hour pharmacodynamics/ pharmacokinetics of biphasic insulin aspart 30 (BiAsp 30) thrice daily treatme...

A Study on Comparison of Glargine Plus Glulisine With Premixed Insulin in Type 2 Diabetes Patients

This study is a multicentre, randomized, open label on comparison of a Long-Acting Basal Insulin Analog Glargine plus Glulisine with Premixed Insulin in Adult Patients with Type 2 Diabetes...

Insulin Glulisine in Adult Subjects With Type 2 Diabetes Receiving Insulin Glargine as Basal Insulin

The purpose of this study is to compare the change in glycemic control, as measured by hemoglobin A1c (HbA1c) from baseline to study week 24, in subjects receiving insulin glulisine as mea...

Insulin Glargine Combination Therapies in Type II Diabetics

To compare efficacy of combination therapy of insulin glargine plus glimepiride and metformin versus 2 injections insulin monotherapy with premixed insulin NPH 30/70 bid in terms of change...

A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes

This study will compare the effect of semaglutide once weekly to insulin aspart 3 times daily as add on to metformin and insulin glargine in people with type 2 diabetes. Participants will ...

PubMed Articles [1882 Associated PubMed Articles listed on BioPortfolio]

Effects of Insulin Treatment with Glargine or Premixed Insulin Lispro Programs in Type 2 Diabetes Mellitus Patients: A Meta-analysis of Randomized Clinical Trials.

The purpose of this study was to compare the efficacy and safety of intensive insulin therapy (premixed insulin lispro vs. insulin glargine) in patients with type 2 diabetes mellitus (T2DM).

Switching from glargine+insulin aspart to glargine+insulin aspart 30 before breakfast combined with exercise after dinner and dividing meals for the treatment of type 2 diabetes patients with poor glucose control - a prospective cohort study.

This study aimed to examine the switch from glargine+once daily insulin aspart (1 + 1 regimen) to glargine+insulin aspart 30 before breakfast combined with exercise and in patients with type 2 dia...

IDEGLIRA IS ASSOCIATED WITH IMPROVED SHORT-TERM CLINICAL OUTCOMES AND COST SAVINGS COMPARED WITH INSULIN GLARGINE U100 PLUS INSULIN ASPART IN THE U.S.

In the DUAL (Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes) VII trial, IDegLira (a combination of insulin degludec and liraglutide) was compared with insulin glargine U100 plus in...

Faster aspart insulin (FIASP®).

Fast-acting insulin aspart (faster aspart), commercialized under the trade name of Fiasp®, is insulin aspart in a new formulation aiming to mimic the physiologic prandial insulin release more closely...

Switching to insulin glargine 300 U/mL: is duration of prior basal insulin therapy important?

To assess the impact of duration of prior basal insulin therapy on study outcomes in people with type 2 diabetes mellitus receiving insulin glargine 300 U/mL (Gla-300) or insulin glargine 100 U/mL (Gl...

Medical and Biotech [MESH] Definitions

A syndrome with excessively high INSULIN levels in the BLOOD. It may cause HYPOGLYCEMIA. Etiology of hyperinsulinism varies, including hypersecretion of a beta cell tumor (INSULINOMA); autoantibodies against insulin (INSULIN ANTIBODIES); defective insulin receptor (INSULIN RESISTANCE); or overuse of exogenous insulin or HYPOGLYCEMIC AGENTS.

Diminished effectiveness of INSULIN in lowering blood sugar levels: requiring the use of 200 units or more of insulin per day to prevent HYPERGLYCEMIA or KETOSIS. It can be caused by the presence of INSULIN ANTIBODIES or the abnormalities in insulin receptors (RECEPTOR, INSULIN) on target cell surfaces. It is often associated with OBESITY; DIABETIC KETOACIDOSIS; INFECTION; and certain rare conditions. (from Stedman, 25th ed)

Insulin that has been modified to contain an ASPARTIC ACID instead of a PROLINE at position 38 of the B-chain.

An insulin preparation that is designed to provide immediate and long term glycemic control in a single dosage. Biphasic insulin typically contains a mixture of REGULAR INSULIN or SHORT-ACTING INSULIN combined with a LONG-ACTING INSULIN.

A recombinant LONG ACTING INSULIN and HYPOGLYCEMIC AGENT that is used to manage BLOOD GLUCOSE in patients with DIABETES MELLITUS.

More From BioPortfolio on "BASAAL PLUS - Better Acceptance of Single Injection Apidra Added to Once Daily Lantus Versus Twice Daily Premixed Insulin in Real Life Use Setting"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Diabetes
Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. The two main types of diabetes are: type 1 diabetes type 2 diabetes In the UK, diabetes affects approximately 2.9 million people. There are a...


Searches Linking to this Trial