Trial Condition(s):
Diabetes Mellitus, Type 2
To evaluate clinical outcome and injection compliance of Scilin (SEAS)
Bayer Identifier:
16372
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, China | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
1
Primary Outcome
- Occurrence rate of serious adverse drug reactions including severe hypoglycaemic eventsTimeframe: up to 12 week
Secondary Outcome
- Occurrence rate of hypoglycemic eventsTimeframe: up to 12 weeks
- Change in HbA1cTimeframe: Baseline and week 12
- Change in FPG (Fasting Plasma Glucose)Timeframe: Baseline and week 12
- Change in PPG (Postprandial Glucose)Timeframe: Baseline and week 12
- The ratio of compliance injection (following physician's advice)Timeframe: up to 12 weeks
- Number and ratio of missed injectionsTimeframe: up to 12 weeks
Additional Information
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