Comparison of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes

Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00097084

Enrollment

324

Registered

2004-11-18

Start date

2004-09-30

Completion date

2005-12-31

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 2

Brief summary

This trial is conducted in Europe and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type 2 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 2 diabetes for at least 12 months * Treated with oral antidiabetic drugs or with any insulin regimen with or without oral antidiabetic drugs * BMI of maximum 40 kg/m2 * HbA1c greater than or equal to 7.0% and less than or equal to 11.0%

Exclusion criteria

* Proliferative retinopathy or maculopathy * Recurrent major hypoglycaemia * Impaired hepatic or renal function * Cardiac problems or uncontrolled hypertension

Design outcomes

Primary

Measure	Time frame
HbA1c	after 1 year trial period

Secondary

Measure	Time frame
Adverse events	—
Body weight	—
Hypoglycemia	—
Blood glucose	—
Insulin Treatment Satisfaction	—

Countries

Finland, France, Norway, Sweden, United States

Outcome results

None listed

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