Advertisement

Topics

Safety and Effectiveness Study of Insulin Glargine (LANTUS) Initiation and Titration in Patients With Type 2 Diabetes

2014-08-27 03:13:33 | BioPortfolio

Summary

Primary Objective:

Percentage of patients achieving Glycosylated Hemoglobin (HbA1c) < 7% with no severe or nocturnal hypoglycemic episodes at 6 months

Secondary Objectives:

- Glycosylated Hemoglobin (HbA1c) change from baseline to 6 months

- Insulin glargine dose at 3 and 6 months

- Hypoglycemic episodes (all types)

Study Design

Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Diabetes Mellitus, Type 2

Intervention

INSULIN GLARGINE

Location

Sanofi-Aventis Investigational Site Number 9
C.a.b.a.
Argentina

Status

Recruiting

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:33-0400

Clinical Trials [5150 Associated Clinical Trials listed on BioPortfolio]

Efficacy and Safety of LixiLan Versus Insulin Glargine Alone Both With Metformin in Japanese With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Drugs

Primary Objective: To compare LixiLan to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to week 26 in patients with type 2 diabetes mellitus. Secondary Object...

PK/PD Study of Gan & Lee's Insulin Glargine Injection in Comparison to Lantus in Type 1 Diabetes

This is a Phase 1, exploratory, single dose, randomized, double-blind, two-way cross over, pilot, glucose clamp study to assess pharmacokinetic and pharmacodynamic effects of Gan & Lee's i...

Insulin Glargine in Type 2 Diabetes

The aim of this project is to confirm the efficacy and safety profile of Insulin glargine in daily practice and to improve the physicians’ knowledge and experience concerning Insulin gla...

Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy

Primary Objective: To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at Month 6, Week 26) in par...

Immunogenicity Study of Insulin Glargine Ezelin vs Lantus in Type 2 Diabetes Mellitus Patients

This is an open-label randomised multicenter clinical study to compare immunogenicity of the drug products Insulin Glargine (Kalbe Farma) and Lantus (Sanofi -Aventis) in type 2 diabetes me...

PubMed Articles [10576 Associated PubMed Articles listed on BioPortfolio]

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.

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 Biosimilar SAR342434 Insulin Lispro in Adults with Type 2 Diabetes, Also Using Insulin Glargine: SORELLA 2 Study.

SAR342434 (SAR-Lis) is a biosimilar (follow-on) of insulin lispro (U100; Humalog®; Ly-Lis). This study aimed to show similar efficacy, safety, and immunogenicity of SAR-Lis versus Ly-Lis in adult pat...

Basal Insulin Peglispro Increases Lipid Oxidation, Metabolic Flexibility, Thermogenesis And Ketone Bodies Compared To Insulin Glargine In Subjects With Type 1 Diabetes Mellitus.

When treated with basal insulin peglispro (BIL), patients with type 1 diabetes mellitus (T1DM) exhibit weight loss and lower prandial insulin requirements versus insulin glargine (GL), while total ins...

A Review of Basal-Bolus Therapy Using Insulin Glargine and Insulin Lispro in the Management of Diabetes Mellitus.

Basal-bolus therapy (BBT) refers to the combination of a long-acting basal insulin with a rapid-acting insulin at mealtimes. Basal insulin glargine 100 U/mL and prandial insulin lispro have been avail...

Medical and Biotech [MESH] Definitions

A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.

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

A subtype of DIABETES MELLITUS that is characterized by INSULIN deficiency. It is manifested by the sudden onset of severe HYPERGLYCEMIA, rapid progression to DIABETIC KETOACIDOSIS, and DEATH unless treated with insulin. The disease may occur at any age, but is most common in childhood or adolescence.

A 51-amino acid pancreatic hormone that plays a major role in the regulation of glucose metabolism, directly by suppressing endogenous glucose production (GLYCOGENOLYSIS; GLUCONEOGENESIS) and indirectly by suppressing GLUCAGON secretion and LIPOLYSIS. Native insulin is a globular protein comprised of a zinc-coordinated hexamer. Each insulin monomer containing two chains, A (21 residues) and B (30 residues), linked by two disulfide bonds. Insulin is used as a drug to control insulin-dependent diabetes mellitus (DIABETES MELLITUS, TYPE 1).

The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).

More From BioPortfolio on "Safety and Effectiveness Study of Insulin Glargine (LANTUS) Initiation and Titration in Patients With Type 2 Diabetes"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Blood
Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells.  In vertebrates, it is composed of blo...

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