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Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes

2014-08-27 03:15:11 | BioPortfolio

Summary

This trial is conducted in Europe, Oceania and in the United States of America (USA).

The aim of this clinical trial is to compare the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart in type 1 diabetes.

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 1

Intervention

NN5401, insulin detemir, insulin aspart, insulin aspart

Location

Novo Nordisk Clinical Trial Call Center
La Mesa
California
United States
91942

Status

Active, not recruiting

Source

Novo Nordisk

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:11-0400

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PubMed Articles [5088 Associated PubMed Articles listed on BioPortfolio]

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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...

Verification of Bioanalytical Method for Quantification of Exogenous Insulin (Insulin Aspart) by the Analyser Advia Centaur® XP.

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Insulin degludec/insulin aspart lowers fasting plasma glucose and rates of confirmed and nocturnal hypoglycaemia independent of baseline HbAlevels, disease duration or BMI: A pooled meta-analysis of phase 3 studies in patients with type 2 diabetes.

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Medical and Biotech [MESH] Definitions

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

A recombinant long-acting insulin and HYPOGLYCEMIC AGENT in which a MYRISTIC ACID is conjugated to a LYSINE at position B29. It is used to manage BLOOD GLUCOSE levels in patients with DIABETES MELLITUS.

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)

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).

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