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Comparison of the impact of biphasic insulin aspart 30(BiAsp30), biphasic insulin aspart 70 (BiAsp 70) and insulin aspart on postprandial glucose and lipid metabolism during two consecutive meals in type 2 diabetics.

Comparison of the impact of biphasic insulin aspart 30(BiAsp30), biphasic insulin aspart 70 (BiAsp 70) and insulin aspart on postprandial glucose and lipid metabolism during two consecutive meals in type 2 diabetics.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-008486-35-AT
Enrollment
Unknown
Registered
2010-02-15
Start date
2010-02-25
Completion date
Unknown
Last updated
2016-11-07

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

Conditions

Diabetes mellitus Typ II MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus

Interventions

Trade Name: Novorapid Product Name: NovoRapid Pharmaceutical Form: Solution for injection INN or Proposed INN: Insulin aspart CAS Number: 116094-23-6 Concentration unit: IU/ml international unit(s)/m

Sponsors

Medizinische Universität Graz, Klinische Abteilung für Endokrinologie und Nuklearmedizin
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Type 2 Diabetes mellitus BMI > 27 kg/m2 Treatment with premixed insulin once or twice daily ± Metformin stable insulin dose in the last 4 weeks Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: HbA1c > 8.5 % Serum creatinine > 1.7 mg/dl ALT or AST > 3x ULN Treatment with sulfonylurea, DPP-IV-inhibitors or glitazones

Design outcomes

Primary

MeasureTime frame
Main Objective: To investigate the impact of 3 insulin preparations on postprandial glucose and lipid metabolism in two consecutive meals in patients with type 2 diabetes.;Secondary Objective: n.a.;Primary end point(s): AUC for postprandial glucose for each meal and both together AUC for postprandial triglycerides for each meals and both together—

Countries

Austria

Outcome results

None listed

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