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Korean Observational Study to Evaluate the Efficacy and Safety of Anagliptin Switching From Other DPP4is in type2 DM

2020-02-17 18:20:57 | BioPortfolio

Summary

This study was designed as a non-interventional, single-group, open-label, multicenter observational study for patients with type 2 diabetes in the real world clinical setting.

Description

Subjects will visit the site on the 12th week (Visit 2) and 24th week (Visit 3) from the registration date (Visit 1) to confirm the efficacy and safety.

Primary endpoint

- HbA1c change after 24 weeks treatment

Secondary endpoint

- Average rate of change in HbA1c after baseline

- Ratio of subjects with HbA1c<7% after 24 weeks

- Ratio of subjects with HbA1c<6.5% after 24 weeks

- Subgroup analysis by gender, age, BMI, medical history, renal function, liver function, conventional DPP4 inhibitors therapy, concomitant Oral Antidiabetic Drug, duration of disease

Safety endpoint : Adverse Event

Study Design

Conditions

Type 2 Diabetes Mellitus

Intervention

Anagliptin

Location

The Catholic University of Korea, Bucheon ST. Mary's hopsital
Bucheon
Korea, Republic of
14647

Status

Recruiting

Source

JW Pharmaceutical

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-02-17T18:20:57-0500

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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.

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).

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 type of diabetes mellitus that is characterized by severe INSULIN RESISTANCE and LIPODYSTROPHY. The latter may be generalized, partial, acquired, or congenital (LIPODYSTROPHY, CONGENITAL GENERALIZED).

A life-threatening complication of diabetes mellitus, primarily of TYPE 1 DIABETES MELLITUS with severe INSULIN deficiency and extreme HYPERGLYCEMIA. It is characterized by excessive LIPOLYSIS, oxidation of FATTY ACIDS, production of KETONE BODIES, a sweet smell to the breath (KETOSIS;) DEHYDRATION; and depressed consciousness leading to COMA.

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