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Evaluation of efficacy and safety after treatment of twice daily mixed insulin analogue in patients with type 2 diabetes

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)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0000388
Enrollment
60
Registered
2012-03-23
Start date
2007-07-01
Completion date
Unknown
Last updated
2019-03-11

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

Conditions

None listed

Interventions

Drug : They will be starting with NovoMix 30 FlexPen at a total daily dose of 0.3 U/kg body weight. It is recommended to give NovoMix 30 FlexPen twice daily at breakfast and at the evening main meal.

Sponsors

Inje University Sanggye Paik Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
HbA1c change

Secondary

MeasureTime frame
fasting glucose;7-point (before and after each meal and at bed time) SMBG

Countries

Korea, Republic of

Contacts

Public ContactKee-Ho Song

Konkuk University Medical Center

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026