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comparison of twice-daily injection of insulin aspart 30 and 50 in patients with type 2 diabetes poorly controlled with oral hypoglycemic agents

comparison of twice-daily injection of insulin aspart 30 and 50 in patients with type 2 diabetes poorly controlled with oral hypoglycemic agents and the factors that influences the efficacy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-16008958
Enrollment
Unknown
Registered
2016-08-02
Start date
2016-08-15
Completion date
Unknown
Last updated
2017-04-18

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

group 1:insulin aspart 30
group 2:insulin aspart 50

Sponsors

The 1st Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Eligible patients will be men and women with type 2 diabetes mellitus, aged 18-80 years old, body mass index of 18-35kg/m2, an HbA1c of 7-11.0%, fasting c-peptipe >0.8ng/ml, blood glucose level is poorly controlled with merformin and sulfonylureas, and with or without alpha-glucosidase inhibitor.

Exclusion criteria

Exclusion criteria: patients who had used aspart 30/50 during the preceding 1 month are not eligible for this studyindividuals who had severe diabetes mellitus complication or infection during the preceding 1 monthimpaired hepatic function (alanine aminotransferase >=3 times upper limit),or impaired kidney function (GFR<30ml/(min*1.73m^2)), had surgery, pregnant or have a intention to be pregnant within 6 months or within lactation periodhad severe mental disorders such as schizophrenia or had tumor are also not eligible for this study.

Design outcomes

Primary

MeasureTime frame
HbA1c;

Secondary

MeasureTime frame
percentage of qualified patients;fasting plasma glucose;blood glucose;dosage of insulin;c peptide;body mass index;HOMA-beta;HOMA-IR;rate of hypoglycemic;oral hypoglycemic agent;

Countries

China

Contacts

Public ContactRan Bai

The 1st Affiliated Hospital of Dalian Medical University

bairan5556@163.com+86 0411 83635963-7137

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 22, 2026