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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01077570
First received: February 26, 2010
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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 Intervention
Diabetes
Diabetes Mellitus, Type 2
Drug: repaglinide

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of minor hypoglycaemic (low blood sugar) episodes [ Time Frame: at Visit 2(8 weeks) and visit 3(16 weeks) ] [ Designated as safety issue: Yes ]
  • Number of adverse drug reactions (ADRs) [ Time Frame: at Visit 2(8 weeks) and visit 3(16 weeks) ] [ Designated as safety issue: Yes ]
  • Change in HbA1c [ Time Frame: after 16 weeks of treatment ] [ Designated as safety issue: No ]
  • Change in fasting blood glucose (FBG) [ Time Frame: after 8 and 16 weeks of treatment ] [ Designated as safety issue: No ]
  • Change in postprandial blood glucose (PBG) [ Time Frame: after 8 and 16 weeks treatment ] [ Designated as safety issue: No ]

Enrollment: 2033
Study Start Date: March 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077570

Locations
China, Beijing
Beijing, Beijing, China, 100004
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01077570     History of Changes
Other Study ID Numbers: AGEE-3822, U1111-1112-6394
Study First Received: February 26, 2010
Last Updated: June 25, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Repaglinide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014