To Evaluate Clinical Outcome and Injection Compliance of Scilin

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Insulin (Scilin N, BAY81-9924); Drug: Insulin (Scilin R _BAY81-9924; Drug: Insulin(Scilin M30_BAY81-9924)

• Registration Number: NCT01588639
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-27
• Study First Submitted QC: 2012-04-30
• Study First Posted: 2012-05-01
• Study Start: 2012-08
• Primary Completion: 2013-10
• Study Completion: 2014-01
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-11
• Last Update Posted: 2015-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2683

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.

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Insulin (Scilin N, BAY81-9924)	-
Group 1	Insulin (Scilin R _BAY81-9924	-
Group 1	Insulin(Scilin M30_BAY81-9924)	-

Primary Outcome Measures

Name	Time	Method
Occurrence rate of serious adverse drug reactions including severe hypoglycaemic events	up to 12 week

Secondary Outcome Measures

Name	Time	Method
Occurrence rate of hypoglycemic events	up to 12 weeks
Change in HbA1c	Baseline and week 12
Change in FPG (Fasting Plasma Glucose)	Baseline and week 12
Change in PPG (Postprandial Glucose)	Baseline and week 12
The ratio of compliance injection (following physician's advice)	up to 12 weeks
Number and ratio of missed injections	up to 12 weeks