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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

April 27, 2012
January 27, 2014
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 ] [ Designated as safety issue: Yes ]
Number of serious adverse drug reactions including severe hypoglycaemic events [ Time Frame: up to 12 week ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01588639 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change in number of hypoglycaemic events [ Time Frame: Baseline and week 12 ] [ 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 ]
  • Frequency of missed injection [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
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
2900
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

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01588639
16372, SL1210CN
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP