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Completed

NCT Number: NCT01275794

Screening Epidemiological Program on Compensation Evaluation of Diabetes Mellitus Type 2 (DMT2) Patients on Oral Anti-diabetic (OAD) Monotherapy and Physicians Satisfaction of Their Usage

The purpose of the study is assessment of glycemic control and physicians satisfaction with results of DM2 OAD monotherapy

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Arkhangelsk, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients have an established diagnosis of T2D
  • Experience of therapy with one OAD during the from 6 months to 5 years before the registration in the Program

Exclusion criteria

  • Experience of therapy with two or more OADs and/or insulin therapy and/or incretin mimetics (exenatide) at any time before registration in the Program
  • Absence of changes in HbAc1 level during the last year before registration in the Program

Treatment and study plan

Primary outcomes

  1. To assess levels of compensation of T2D by HbA1c levels in patients on OAD monotherapy

    Time frame: 1 visit within 4 month

  2. To assess frequency of target levels of HbA1c ≤ 7% in patients with T2D during OAD monotherapy

    Time frame: 1 visit within 4 month

Secondary outcomes

  1. To assess fasting glycemia in patients with T2D on OAD monotherapy

    Time frame: 1 visit within 4 month

  2. To assess postprandial levels of glycemia in patients with T2D during OAD monotherapy

    Time frame: 1 visit within 4 month

  3. To evaluate the physicians' satisfaction with the results of OAD monotherapy in patients with Typ 2 Diabetes (T2D)

    Time frame: 1 visit within 4 month

  4. To compare the results of OAD monotherapy in different groups of patients

    Time frame: 1 visit within 4 month

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

Screening Epidemiological Program on Compensation Evaluation of DM Type 2 Patients on OAD Monotherapy and Physicians Satisfaction of Their Usage

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 12, 2011
Registry last updated
Jun 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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