Evaluation of efficacy and safety after treatment of twice daily mixed insulin analogue in patients with type 2 diabetes
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0000388
- Lead Sponsor
- Inje University Sanggye Paik Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
Type 2 diabetes according to WHO classification.
1) Treated with OAD(s) for at three months.
2) Age = 18 years.
3) Body mass index (BMI) = 25.0 kg/m2.
4) Glycosylated hemoglobin (HbA1c) = 7.5 % and = 10.0 % (both inclusive)
The patients who have history of drug or alcohol abuse, were treated with any other drug known to affect blood glucose (i.e., MAO-inhibitors, beta-adrenergic agents, anabolic steroids, and systemic glucocorticoids), have impaired renal function with serum creatinine = 1.7 mg/dL, have cardiac disease defined as: decompensated heart failure (NYHA classification III and IV), unstable angina pectoris, myocardial infarction within the last 12 months, or severe uncontrolled hypertension (systolic blood pressure when seated > 180 mmHg and/or diastolic blood pressure > 110 mmHg), or have proliferative retinopathy and/or advanced neuropathy as judged by the investigator. Pregnant or breast-feeding, or have the intention to become pregnant.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c change
- Secondary Outcome Measures
Name Time Method fasting glucose;7-point (before and after each meal and at bed time) SMBG