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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

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

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

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PubMed Articles [1955 Associated PubMed Articles listed on BioPortfolio]

Biphasic insulin aspart-30 reduces glycemic variability to a greater degree than insulin detemir: A randomized controlled trial of once-daily insulin regimens using continuous glucose monitoring.

We compared the efficacy of insulin detemir and biphasic insulin aspart-30 given in the morning as an add-on to oral hypoglycemic agents (OHAs) in type 2 diabetic patients.

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...

Efficacy and safety of fast-acting insulin aspart in comparison with insulin aspart in type 1 diabetes (onset 1): a 52-week, randomized, treat-to-target, phase 3 trial.

Compare safety and efficacy of fast-acting insulin aspart (faster aspart) with conventional insulin aspart (IAsp) in adults with type 1 diabetes (T1D).

Efficacy and Safety of MYL-1501D Versus Insulin Glargine in Patients With Type 1 Diabetes After 52 Weeks: Results of the Phase 3 INSTRIDE 1 Study.

Insulin glargine, a long-acting human insulin analogue, allows for once-daily basal use in patients with type 1 diabetes mellitus (T1DM). MYL-1501D is a proposed insulin glargine biosimilar.

Serum insulin bioassay reflects insulin sensitivity and requirements in type 1 diabetes.

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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.

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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...


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