A multi-center, open label, observational trial to evaluate efficacy and safety of stepwise insulin treatment as add-on to current OAD therapy in subjects with type 2 diabetes mellitus.

A multi-center, open label, observational trial to evaluate efficacy and safety of stepwise insulin treatment as add-on to current OAD therapy in subjects with type 2 diabetes mellitus. - A multi-center, open label, observational trial to evaluate efficacy and safety of stepwise insulin treatment as add-on to current OAD therapy in subjects with type 2 diabetes mellitus (STEADY study).

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000002077

Enrollment

Registered

2009-06-17

Start date

2010-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. A consent form for participating in this study is submitted 2. Patients diagnosed with type 2 diabetes in more than 6 months 3. Males and females of age >= 18 years 4. HbA1c >= 7.0 %, <=10.0% 5. Insulin na&iuml;ve patients 6. Patients treated using one or more oral anti-diabetes drugs below: -Metoformine -Sulfonil-urea -Pioglitazone 7. Patients able and willing to perform self-monitoring of blood glucose

Exclusion criteria

Exclusion criteria: 1. Patients who have experience of insulin treatment 2. Pregnant, or intention of becoming pregnant. 3. Patients who are judged by investigators as inappropriate subject to participant this trail.

Design outcomes

Primary

Measure	Time frame
Percentage of patients who reach target HbA1c under 6.5%	—

Secondary

Measure	Time frame
1. Change of HbA1c, 1.5AG, fasting plasma glucose, 7-point SMBG, 2-hour postprandial glucose level 2. Hypoglycemia episodes and other adverse events 3. Markers of cardiovascular risk [Human sensitive C-reactive peptide (hsCRP), Soluble Intercellular Adhesion Molecule(sICAM), soluble vascular cell adhesion molecule 1 (sVCAM-1) and von Willebrand Factor (vWF)] 4. Circumference of waist and hip 5. Change of height, weight, BMI 6. Change of insulin dose (total dose, basal dose, bolus dose) 7. Change of patients' QOL and satisfaction	—

Measure

Time frame

1. Change of HbA1c, 1.5AG, fasting plasma glucose, 7-point SMBG, 2-hour postprandial glucose level 2. Hypoglycemia episodes and other adverse events 3. Markers of cardiovascular risk [Human sensitive C-reactive peptide (hsCRP), Soluble Intercellular Adhesion Molecule(sICAM), soluble vascular cell adhesion molecule 1 (sVCAM-1) and von Willebrand Factor (vWF)] 4. Circumference of waist and hip 5. Change of height, weight, BMI 6. Change of insulin dose (total dose, basal dose, bolus dose) 7. Change of patients' QOL and satisfaction

—

Countries

Japan

Contacts

Public ContactTomoko Nakagami

Tokyo Women's Medical University Diabetes Center

nakagami@dmc.twmu.ac.jp03-3353-8111

Outcome results