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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01077570
Recruitment Status : Completed
First Posted : March 1, 2010
Last Update Posted : June 26, 2014
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: repaglinide

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Study Type : Observational
Actual Enrollment : 2033 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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.
Study Start Date : March 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Repaglinide

Group/Cohort Intervention/treatment
Repaglinide Drug: repaglinide
Repaglinide prescribed at the discretion of the investigator, according to local labelling, and evaluated at week 0, 8 and 16 of the study

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from both general and speciality practice settings who have been deemed appropriate to receive Repaglinide as initial treatment and as part of routine out-patient care by the prescribing physician.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01077570

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China, Beijing
Beijing, Beijing, China, 100004
Sponsors and Collaborators
Novo Nordisk A/S
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
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Responsible Party: Novo Nordisk A/S Identifier: NCT01077570    
Other Study ID Numbers: AGEE-3822
U1111-1112-6394 ( Other Identifier: WHO )
First Posted: March 1, 2010    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs