Linagliptin 2.5 mg Twice Daily Versus 5 mg Once Daily as add-on Therapy to Twice Daily Metformin in Type 2 Diabetes

03:29 EST 22nd December 2014 | BioPortfolio

Summary

The objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control. It is planned to show non-inferiority of linagliptin 2.5 mg twice daily compared to 5 mg once daily and each treatment's superiority over placebo.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Diabetes Mellitus, Type 2

Intervention

linagliptin low dose, placebo, linagliptin medium dose

Location

1218.62.32003 Boehringer Ingelheim Investigational Site
De Pinte
Alberta
Belgium

Status

Recruiting

Source

Boehringer Ingelheim Pharmaceuticals

Results (where available)

View Results

Links

Clinical Trials [4066 Associated Clinical Trials listed on BioPortfolio]

Finding a Safe and Effective Dose of Linagliptin in Pediatric Patients With Type 2 Diabetes

The main objective of this study is to identify the dose of linagliptin in paediatric patients. Other efficacy objectives include the comparison of the lowering effect of linagliptin low ...

Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone

The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add on therapy to metf...

30 Week Parallel Group Comparison Study of Linagliptin + Pioglitazone (5+15, 5+30 and 5+45 mg) qd Versus Respective Monotherapies, Followed by a Comparison of 5mg+30mg and 5mg+45mg Versus Respective Monotherapies in Type 2 Diabetes for up to 54 Weeks

The primary objective is to demonstrate superior glycaemic control (HbA1c reduction) after 30 weeks of linagliptin/pioglitazone (5/15, 5/30 and 5/45 mg) versus the respective individual mo...

Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes

The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to Placebo during long term treatment (52 weeks and l...

Efficacy and Safety of Linagliptin in Elderly Patients With Type 2 Diabetes

The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given for 24 weeks as add-on therapy to st...

PubMed Articles [12697 Associated PubMed Articles listed on BioPortfolio]

The dipeptidyl peptidase-4 inhibitor linagliptin lowers postprandial glucose and improves measures of β-cell function in type 2 diabetes.

Progressive deterioration of pancreatic β-cell function in patients with type 2 diabetes mellitus (T2DM) contributes to worsening of hyperglycaemia. To investigate the effects of the dipeptidyl pepti...

Safety and Tolerability of Linagliptin in Patients With Type 2 Diabetes: A Comprehensive Pooled Analysis of 22 Placebo-Controlled Studies.

Dipeptidyl peptidase (DPP)-4 inhibitors are an increasingly used antihyperglycemic therapy for patients with type 2 diabetes mellitus (T2DM). Linagliptin, an orally administered DPP-4 inhibitor, has d...

Effect of linagliptin compared to glimepiride on postprandial glucose metabolism, islet cell function, and vascular function parameters in patients with type 2 diabetes mellitus on ongoing metformin treatment.

The goal of this study was to investigate the effects of linagliptin compared to glimepiride on alpha and beta cell function and several vascular biomarkers after a standardised test meal.

Linagliptin enhances neural stem cell proliferation after stroke in type 2 diabetic mice.

Dipeptidyl peptidase 4 (DPP-4) inhibitors are current drugs for the treatment of type 2 diabetes (T2D) based on their main property to enhance endogenous glucagon-like peptide-1 (GLP-1) levels, thus i...

Influence of TCF7L2 gene variants on the therapeutic response to the dipeptidylpeptidase-4 inhibitor linagliptin.

Individuals carrying variants of the transcription factor 7-like 2 gene (TCF7L2) are at increased risk for type 2 diabetes. These metabolic genetic risk factors have been linked to diminished pancreat...

Medical and Biotech [MESH] Definitions

The dose amount of poisonous or toxic substance or dose of ionizing radiation required to kill 50% of the tested population.

The highest dose of a biologically active agent given during a chronic study that will not reduce longevity from effects other than carcinogenicity. (from Lewis Dictionary of Toxicology, 1st ed)

Administration of the total dose of radiation (RADIATION DOSAGE) in parts, at timed intervals.

Radiotherapy where there is improved dose homogeneity within the tumor and reduced dosage to uninvolved structures. The precise shaping of dose distribution is achieved via the use of computer-controlled multileaf collimators.

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.

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