To Evaluate Clinical Outcome and Injection Compliance of Scilin

Bayer2,683 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,683

Conditions

Diabetes Mellitus, Type 2

Interventions

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 _BAY81-9924DRUG

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Many Locations, China

Outcomes

Primary Outcomes

Occurrence rate of serious adverse drug reactions including severe hypoglycaemic events

Time frame: up to 12 week

Secondary Outcomes

Occurrence rate of hypoglycemic events

Time frame: up to 12 weeks

Change in HbA1c

Time frame: Baseline and week 12

Change in FPG (Fasting Plasma Glucose)

Time frame: Baseline and week 12

Change in PPG (Postprandial Glucose)

Time frame: Baseline and week 12

The ratio of compliance injection (following physician's advice)

Time frame: up to 12 weeks

Number and ratio of missed injections

Time frame: up to 12 weeks

Data from ClinicalTrials.gov

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