Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes

Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00312104

Enrollment

325

Registered

2006-04-07

Start date

2002-04-30

Completion date

2003-03-31

Last updated

2017-01-27

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

The trial is conducted in Europe and Africa. The aim of the trial is to compare the use of insulin detemir twice daily combined with mealtime insulin aspart against that of insulin glargine once daily combined with mealtime insulin aspart. The trial involves patients with Type 1 Diabetes.

Interventions

DRUGinsulin detemir

DRUGinsulin glargine

DRUGinsulin aspart

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Type 1 diabetes for at least 12 months * Current daily insulin dose of more than 1.4 IU/kg * BMI lesser than or equal to 35 kg/m2 * HbA1c greater than 7.5% and less than or equal to 12.0% * In Austria, age more than 19 years

Exclusion criteria

* Proliferate retinopathy or maculopathy * Recurrent major hypoglycaemia * Any condition or disease such as uncontrolled hypertension or AIDS/HIV that rule out trial participation according to the judgement of the investigator

Design outcomes

Primary

Measure	Time frame
HbA1c	after 26 weeks of treatment

Secondary

Measure	Time frame
Adverse events	—
Body weight	—
Blood glucose	—
Hypoglycaemia	—

Countries

Austria, Germany, South Africa

Outcome results

None listed

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