Text Size

To Evaluate Clinical Outcome and Injection Compliance of Scilin (SEAS)

This study is currently recruiting participants.
Verified April 2013 by Bayer
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01588639
First received: April 27, 2012
Last updated: April 3, 2013
Last verified: April 2013
History of Changes
  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.


Condition Intervention
Diabetes Mellitus, Type 2
 Drug: Insulin (Scilin N, BAY81-9924)
Drug: Insulin (Scilin R _BAY81-9924
Drug: Insulin(Scilin M30_BAY81-9924)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Occurrence rate of serious adverse drug reactions including severe hypoglycaemic events [ Time Frame: up to 12 week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 3000
Study Start Date: August 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588639

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
China
Recruiting
Many Locations, China
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer Healthcare pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier: NCT01588639     History of Changes
Other Study ID Numbers: 16372, SL1210CN
Study First Received: April 27, 2012
Last Updated: April 3, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Bayer:
Recombinant human insulin
T2DM
Safety
Efficacy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013