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OpenTrials
Completed

NCT Number: NCT01588639

To Evaluate Clinical Outcome and Injection Compliance of Scilin

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin (Scilin N, BAY81-9924)

Drug

Subjects are treated with recombinant human insulin-SciLin N, SciLin R and SciLin M30 (alone or in combination) in routine clinical practice.

Insulin (Scilin R _BAY81-9924

Drug

Subjects are treated with recombinant human insulin-SciLin N, SciLin R and SciLin M30 (alone or in combination) in routine clinical practice

Insulin(Scilin M30_BAY81-9924)

Drug

Subjects are treated with recombinant human insulin-SciLin N, SciLin R and SciLin M30 (alone or in combination) in routine clinical practice

Primary outcomes

  1. Occurrence rate of serious adverse drug reactions including severe hypoglycaemic events

    Time frame: up to 12 week

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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)

Acronym: SEAS

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
May 1, 2012
Registry last updated
Jan 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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