KCT0000388
Completed
N/A
Evaluation of efficacy and safety after treatment of twice daily NovoMix30 in patients with type 2 diabetes A multi-centre, open-labelled, single-arm tria (Phase 4)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Endocrine, nutritional and metabolic disease
- Sponsor
- Inje University Sanggye Paik Hospital
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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