Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agent Failure

2014-08-27 03:13:54 | BioPortfolio


Primary objective of the comparative period (24 weeks) is to demonstrate the superiority of insulin glargine over liraglutide in terms of percentage of patients reaching a Glycosylated Haemoglobin (HbA1c) < 7% at the end of the comparative period in Type 2 diabetic patients failing lifestyle management and oral agents

Secondary objectives of the comparative period :

>To assess the effect of insulin glargine in comparison with liraglutide on:

- HbA1c level

- Percentage of patients whose HbA1c has decreased but remains >= 7% at the end of the comparative period

- Percentage of patients whose HbA1c has increased at the end of the comparative period

- Fasting Plasma Glucose (FPG)

- 7-point Plasma Glucose (PG) profiles

- Hypoglycemia occurrence

- Body weight

- Adverse events

Objectives of the extension period (24 weeks):

>To assess the effect of insulin glargine in patients not adequately controlled with liraglutide on:

- HbA1c level


- 7-point PG profiles

- Hypoglycemia occurrence

- Body weight

- Adverse events

Study Design

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


Diabetes Mellitus, Type 2




Not yet recruiting



Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:13:54-0400

Clinical Trials [5833 Associated Clinical Trials listed on BioPortfolio]

Effects of Adding Liraglutide vs Insulin Glargine to Prandial Insulin in Type 2 Diabetes Patients

The present 24-week, prospective, open-label, randomized, multicenter, parallel group trial is carried to investigate and evaluate the effectiveness and safety of adding Liraglutide vs ins...

A Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i in Subjects With Type 2 Diabetes Mellitus

This trial is conducted globally. The aim of this trial is comparing glycaemic control and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) as add-on thera...

A 104 Week Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus

This trial is conducted in Africa, Asia, Europe, North America and South America. The purpose is to compare long-term glycaemic control of insulin degludec/liraglutide (IDegLira) versus in...

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...

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...

PubMed Articles [10335 Associated PubMed Articles listed on BioPortfolio]


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...

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).

Liraglutide, sitagliptin and insulin glargine added to metformin: the effect on body weight and intrahepatic lipid in patients with type 2 diabetes mellitus and NAFLD.

To investigate the effect of anti-diabetic agents on nonalcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes (T2DM), 75 patients with T2DM and NAFLD under inadequate glycemic control...

Retrospective Analysis of an Insulin-to-Liraglutide Switch in Patients with Type 2 Diabetes Mellitus.

Insulin and the GLP-1 receptor agonist liraglutide are both effective in reaching glycemic targets. The efficacy of an insulin-to-liraglutide switch in an obese population with concurrent use of sulfo...

Cost-Effectiveness of Insulin Degludec vs. Insulin Glargine U100 in Type 1 and Type 2 Diabetes Mellitus in a UK Setting.

Understanding which therapeutic innovations in diabetes represent the best value requires rigorous economic evaluation. Data from randomised controlled trials and observational studies indicate that i...

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 "Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agent Failure"

Quick Search


Relevant Topics

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...

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...

Searches Linking to this Trial