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NCT Number: NCT01077570

An Observational Study Investigating the Safety and Effectiveness of Repaglinide in Chinese Patients

This study is conducted in Asia. The aim of this observational study is, under normal clinical practice conditions, to investigate the clinical safety and effectiveness in Chinese patients with type 2 diabetes who have never received anti-diabetic treatment before.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing, Beijing Municipality, 100004, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • HbA1c more than 6.5%, no anti-diabetes treatment accepted before entering the study

Exclusion criteria

  • Subjects who received any anti-diabetic treatment previously
  • Known or suspected allergy to trial product(s) or related products.
  • Subjects who previously enrolled in this study.
  • Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.

Treatment and study plan

repaglinide

Drug

Repaglinide prescribed at the discretion of the investigator, according to local labelling, and evaluated at week 0, 8 and 16 of the study

Primary outcomes

  1. Number of serious adverse drug reactions (SADRs) including major hypoglycaemic (low blood sugar) events

    Time frame: at Visit 2(8 weeks) and visit 3(16 weeks)

Secondary outcomes

  1. Number of minor hypoglycaemic (low blood sugar) episodes

    Time frame: at Visit 2(8 weeks) and visit 3(16 weeks)

  2. Number of adverse drug reactions (ADRs)

    Time frame: at Visit 2(8 weeks) and visit 3(16 weeks)

  3. Change in HbA1c

    Time frame: after 16 weeks of treatment

  4. Change in fasting blood glucose (FBG)

    Time frame: after 8 and 16 weeks of treatment

  5. Change in postprandial blood glucose (PBG)

    Time frame: after 8 and 16 weeks treatment

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

The Clinical Safety and Effectiveness of Repaglinide in Treatment-naive Type 2 Diabetes Subjects in China. A 16-week Multicentre, Prospective, Open Label, Non-interventional Study.

Acronym: SAFE

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 1, 2010
Registry last updated
Jun 26, 2014

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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