To Evaluate Clinical Outcome and Injection Compliance of Scilin

Diabetes Mellitus, Type 2 Clinical Trial

— SEAS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01588639
• Other study ID #: 16372
• Secondary ID: SL1210CN
• Status: Completed
• Phase: N/A
• First received: April 27, 2012
• Last updated: January 11, 2015
• Start date: August 2012
• Est. completion date: January 2014

Study information

• Verified date: January 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2683
• Est. completion date: January 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence rate of serious adverse drug reactions including severe hypoglycaemic events		up to 12 week	Yes
Secondary	Occurrence rate of hypoglycemic events		up to 12 weeks	Yes
Secondary	Change in HbA1c		Baseline and week 12	No
Secondary	Change in FPG (Fasting Plasma Glucose)		Baseline and week 12	No
Secondary	Change in PPG (Postprandial Glucose)		Baseline and week 12	No
Secondary	The ratio of compliance injection (following physician's advice)		up to 12 weeks	No
Secondary	Number and ratio of missed injections		up to 12 weeks	No

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
•   Click here and search for websynopsis results provided by Bayer