Comparison of Insulin Detemir or Insulin Glargine as Add on to Oral Antidiabetic Drugs in Type 2 Diabetes

Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine as Add-on to Current Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00283751

Enrollment

583

Registered

2006-01-30

Start date

2003-03-31

Completion date

2004-11-30

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 aim of the trial is to test if Insulin Detemir as add-on to current Oral Antidiabetic Drug treatment is at least as effective as Insulin Glargine as add-on to current Oral Antidiabetic Drug treatment in reducing HbA1c in patients with Type 2 Diabetes.

Interventions

DRUGinsulin detemir

DRUGinsulin glargine

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 more than 12 months, and no previous insulin treatment * Oral Antidiabetic Drug treatment for at least 4 months * Body Mass Index (BMI) less than 40 kg/m2 * HbA1c 7.5-10.0%

Exclusion criteria

* Current or previous treatment with thiazolidinediones within the last 6 months * Oral Antidiabetic Drug treatment with combination of three or more Oral Antidiabetic Drugs within the last 6 months * Proliferative retinopathy or maculopathy * Known hypoglycaemia unawareness

Design outcomes

Primary

Measure	Time frame
HbA1c	after 52 weeks

Secondary

Measure	Time frame
Insulin antibodies	—
Incident of hypoglycaemic episodes and adverse events	—
Plasma glucose profiles	—
Change in body weight	—

Countries

Austria, Belgium, France, Germany, Ireland, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026