Comparison of Insulin Detemir and Insulin Semilente®MC in Type 1 Diabetes

Comparison of Efficacy and Safety of Insulin Detemir and Insulin Semilente®MC in Children, Adolescents and Young Adults With Type 1 Diabetes on Basal-Bolus Regimen.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00184639

Enrollment

Registered

2005-09-16

Start date

2004-08-16

Completion date

2005-11-22

Last updated

2017-02-24

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

Conditions

Diabetes, Diabetes Mellitus, Type 1

Brief summary

This trial is conducted in Europe. A 32-week efficacy and safety comparison of insulin detemir and insulin semilente MC in children between 6 and 21 years with type 1 diabetes.

Interventions

DRUGinsulin detemir

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 18 Years

Healthy volunteers

Inclusion criteria

* Type 1 diabetes * Current intensified insulin treatment * Injection of insulin Semilente®MC at bedtime for at least 6 weeks * BMI maximum 32 kg/m\^2 * HbA1c \> 5.5 % and \< 12.0 %

Exclusion criteria

* Current treatment with premixed insulin(s) * Impaired hepatic or renal function * Recurrent major hypoglycaemia

Design outcomes

Primary

Measure	Time frame
Fasting plasma glucose	after 16 and 32 weeks, respectively

Secondary

Measure	Time frame
Adverse events	—
HbA1c results at the end of each treatment period	—
Blood glucose	—
Standard Laboratory Safety Parameters	—
Hypoglycaemia	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026