To Evaluate Clinical Outcome and Injection Compliance of Scilin (SEAS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01588639
First received: April 27, 2012
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

This is a prospective, multi-center, open-label, non-interventional, 12-week study in people with type 2 diabetes mellitus who are treated with recombinant human insulin-SciLin N, SciLin R and SciLin M30 (alone or in combination) in routine clinical practice. The term study insulins will be used in this protocol for these drugs and combinations.


Condition Intervention
Diabetes Mellitus, Type 2
Drug: Insulin (Scilin N, BAY81-9924)
Drug: Insulin (Scilin R _BAY81-9924
Drug: Insulin(Scilin M30_BAY81-9924)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Multi-centre, Non-randomized, Open-label, Non-interventional Study to Evaluate the Safety, Efficacy and Injection Compliance of Scilin N, Scilin R or Scilin M30 in Chinese Type 2 Diabetes Mellitus (T2DM)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Occurrence rate of serious adverse drug reactions including severe hypoglycaemic events [ Time Frame: up to 12 week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Occurrence rate of hypoglycemic events [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
  • Change in HbA1c [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
  • Change in FPG (Fasting Plasma Glucose) [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
  • Change in PPG (Postprandial Glucose) [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
  • The ratio of compliance injection (following physician's advice) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Number and ratio of missed injections [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 2900
Study Start Date: August 2012
Study Completion Date: January 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Insulin (Scilin N, BAY81-9924)
Subjects are treated with recombinant human insulin-SciLin N, SciLin R and SciLin M30 (alone or in combination) in routine clinical practice.
Drug: Insulin (Scilin R _BAY81-9924
Subjects are treated with recombinant human insulin-SciLin N, SciLin R and SciLin M30 (alone or in combination) in routine clinical practice
Drug: Insulin(Scilin M30_BAY81-9924)
Subjects are treated with recombinant human insulin-SciLin N, SciLin R and SciLin M30 (alone or in combination) in routine clinical practice

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

Inclusion Criteria:

  • Based on physicians' clinical judgement, subjects who are treated with SciLin N, SciLin R and SciLin M30 ( alone or in combination) will be eligible to be included in this clinical study.

Exclusion Criteria:

Subjects with one of the conditions listed below will be excluded:

Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 6 months Subjects who have to be treated with other insulins simultaneously Subjects who are participating in other diabetes clinical studies at the same time

  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: NCT01588639

Locations
China
Many Locations, China
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01588639     History of Changes
Other Study ID Numbers: 16372, SL1210CN
Study First Received: April 27, 2012
Last Updated: January 27, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Bayer:
Recombinant human insulin
T2DM
Safety
Efficacy

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

ClinicalTrials.gov processed this record on August 28, 2014