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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01588639

Acronym

SEAS

Enrollment

2683

Registered

2012-05-01

Start date

2012-08-31

Completion date

2014-01-31

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Recombinant human insulin, T2DM, Safety, Efficacy

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.

Interventions

DRUGInsulin (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.

DRUGInsulin (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

DRUGInsulin(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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026