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The Copenhagen Insulin and Metformin Therapy Trial

2014-08-27 03:31:24 | BioPortfolio

Summary

T2DM patients (T2DM) have an increased mortality rate due to macrovascular disease. The primary objective of the study is to evaluate the effect of an 18-month treatment with metformin versus placebo in combination with one of three insulin analogue regimens following a treat-to-target principle. The primary outcome measure is change in wall thickness of the carotic arteries(CIMT)measured by ultrasound. A total of 900 patients with T2DM and HbA1c above 7.5% will be included.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Type 2 Diabetes

Intervention

metformin, insulin detemir, insulin aspart + insulin aspart protamin, Insulin aspart

Location

Amager Hospital
Copenhagen
-
Denmark
2300

Status

Recruiting

Source

Steno Diabetes Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:31:24-0400

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PubMed Articles [2175 Associated PubMed Articles listed on BioPortfolio]

Faster aspart insulin (FIASP®).

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

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Characterisation of insulin analogues therapeutically available to patients.

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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 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 biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289)

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.

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