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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01588639
First Posted: May 1, 2012
Last Update Posted: January 13, 2015
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.
Information provided by (Responsible Party):
Bayer
April 27, 2012
May 1, 2012
January 13, 2015
August 2012
October 2013   (Final data collection date for primary outcome measure)
Occurrence rate of serious adverse drug reactions including severe hypoglycaemic events [ Time Frame: up to 12 week ]
Number of serious adverse drug reactions including severe hypoglycaemic events [ Time Frame: up to 12 week ]
Complete list of historical versions of study NCT01588639 on ClinicalTrials.gov Archive Site
  • Occurrence rate of hypoglycemic events [ Time Frame: up to 12 weeks ]
  • Change in HbA1c [ Time Frame: Baseline and week 12 ]
  • Change in FPG (Fasting Plasma Glucose) [ Time Frame: Baseline and week 12 ]
  • Change in PPG (Postprandial Glucose) [ Time Frame: Baseline and week 12 ]
  • The ratio of compliance injection (following physician's advice) [ Time Frame: up to 12 weeks ]
  • Number and ratio of missed injections [ Time Frame: up to 12 weeks ]
  • Change in number of hypoglycaemic events [ Time Frame: Baseline and week 12 ]
  • Change in HbA1c [ Time Frame: Baseline and week 12 ]
  • Change in FPG (Fasting Plasma Glucose) [ Time Frame: Baseline and week 12 ]
  • Change in PPG (Postprandial Glucose) [ Time Frame: Baseline and week 12 ]
  • The ratio of compliance injection (following physician's advice) [ Time Frame: up to 12 weeks ]
  • Frequency of missed injection [ Time Frame: up to 12 weeks ]
Not Provided
Not Provided
 
To Evaluate Clinical Outcome and Injection Compliance of Scilin
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)
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Primary care clinic
Diabetes Mellitus, Type 2
  • 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
Group 1
Interventions:
  • Drug: Insulin (Scilin N, BAY81-9924)
  • Drug: Insulin (Scilin R _BAY81-9924
  • Drug: Insulin(Scilin M30_BAY81-9924)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2683
January 2014
October 2013   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01588639
16372
SL1210CN ( Other Identifier: company internal )
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
January 2015