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

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ClinicalTrials.gov Identifier: NCT01588639
Recruitment Status : Completed
First Posted : May 1, 2012
Last Update Posted : January 13, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
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
Actual Enrollment : 2683 participants
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)
Study Start Date : August 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. Occurrence rate of serious adverse drug reactions including severe hypoglycaemic events [ Time Frame: up to 12 week ]

Secondary Outcome Measures :
  1. Occurrence rate of hypoglycemic events [ Time Frame: up to 12 weeks ]
  2. Change in HbA1c [ Time Frame: Baseline and week 12 ]
  3. Change in FPG (Fasting Plasma Glucose) [ Time Frame: Baseline and week 12 ]
  4. Change in PPG (Postprandial Glucose) [ Time Frame: Baseline and week 12 ]
  5. The ratio of compliance injection (following physician's advice) [ Time Frame: up to 12 weeks ]
  6. Number and ratio of missed injections [ Time Frame: up to 12 weeks ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01588639


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01588639     History of Changes
Other Study ID Numbers: 16372
SL1210CN ( Other Identifier: company internal )
First Posted: May 1, 2012    Key Record Dates
Last Update Posted: January 13, 2015
Last Verified: January 2015

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, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs