Optimal timing of rapid-acting insulin analogues administration before meal - Optimal Lag Time Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-005598-36-NL

Enrollment

Registered

2008-11-11

Start date

2009-01-22

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Diabetes type 1 We hypothesize that administration of rapid-acting insulin analogue before the meal will result in better postprandial glucose curves. MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus

Interventions

Trade Name: Novorapid Insulin Aspart Product Name: Novorapid

insulin Aspart Pharmaceutical Form: Solution for injection INN or Proposed INN: INSULIN ASPART CAS Number: 116094236 Concentration unit: IU international unit(s) Concentration type: equal Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Men or women aged from 18 to 75 years Type 1 diabetes according to the WHO definition Treated with insulin for at least 2 years and by CSII for at least 6 months Body mass index (BMI) =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnancy (women of childbearing potential must have an adequate contraception) or breastfeeding Treatment with systemic corticosteroids Impaired renal function as shown by serum creatinine = 133 umol/l in men or =124 umol/l in women Known impaired hepatic function defined as alanine aminotransferase (ALAT) and / or aspart aminotransferase (ASAT) tree times greater the upper limit of the normal range Alcohol or drug abuse in the last year Mental condition rendering the patient unable to understand the nature and scope of the study

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to define the optimal timing of rapid-acting insulin analogues administration, which is defined as the smallest glucose excursions after a meal. Insulin administration 15 or 30 minutes before the meal are compared to insulin administration at the start of the meal;Secondary Objective: The secondary objective is to define the best timing of rapid-acting insulin analogues administration defined as smallest hypoglycaemic excursions after a meal;Primary end point(s): The primary endpoint is the area under the curve of plasma glucose levels from start until 5 hours postprandial.	—

Measure

Time frame

Main Objective: The primary objective is to define the optimal timing of rapid-acting insulin analogues administration, which is defined as the smallest glucose excursions after a meal. Insulin administration 15 or 30 minutes before the meal are compared to insulin administration at the start of the meal;Secondary Objective: The secondary objective is to define the best timing of rapid-acting insulin analogues administration defined as smallest hypoglycaemic excursions after a meal;Primary end point(s): The primary endpoint is the area under the curve of plasma glucose levels from start until 5 hours postprandial.

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Countries

Netherlands

Outcome results

None listed

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