check_circleStudy Completed

Diabetes Mellitus, Type 2

Bayer Identifier:

16372

ClinicalTrials.gov Identifier:

NCT01588639

EudraCT Number:

Not Available

EU CT Number:

Not Available
To evaluate clinical outcome and injection compliance of Scilin

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - 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.
  • 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

Trial summary

Enrollment Goal
2683
Trial Dates
August 2012 - January 2014
Phase
N/A
Could I Receive a placebo
No
Products
SciLin (Human recombinant insulin, BAY81-9924)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, China

Primary Outcome

  • Occurrence rate of serious adverse drug reactions including severe hypoglycaemic events
    date_rangeTime Frame:
    up to 12 week
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Occurrence rate of hypoglycemic events
    date_rangeTime Frame:
    up to 12 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Change in HbA1c
    date_rangeTime Frame:
    Baseline and week 12
    enhanced_encryption
    Safety Issue:
    No
  • Change in FPG (Fasting Plasma Glucose)
    date_rangeTime Frame:
    Baseline and week 12
    enhanced_encryption
    Safety Issue:
    No
  • Change in PPG (Postprandial Glucose)
    date_rangeTime Frame:
    Baseline and week 12
    enhanced_encryption
    Safety Issue:
    No
  • The ratio of compliance injection (following physician's advice)
    date_rangeTime Frame:
    up to 12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Number and ratio of missed injections
    date_rangeTime Frame:
    up to 12 weeks
    enhanced_encryption
    Safety Issue:
    No

Trial design

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)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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