Comparison of Insulin Detemir With NPH Insulin in Type 1 Diabetes

2 Year Efficiency and Safety Comparison of Insulin Detemir and NPH Insulin in Type 1 Diabetes.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00184665

Enrollment

501

Registered

2005-09-16

Start date

2004-06-30

Completion date

2006-09-30

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 1

Brief summary

This trial is conducted in Africa, Asia, Europe, Oceania, and South America. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir compared to NPH insulin administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight, and insulin antibodies and side effects).

Interventions

DRUGinsulin detemir

DRUGinsulin NPH

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 * Currently on basal-bolus regimen * BMI = 35.0 kg/m2 * HbA1c =11.0%

Exclusion criteria

* Proliferative retinopathy or maculopathy * Recurrent major hypoglycaemia * Cardial problems * Uncontrolled hypertension * Impaired hepatic or renal function

Design outcomes

Primary

Measure	Time frame
HbA1c	after a two-year trial period

Secondary

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

Countries

Argentina, Australia, Bulgaria, Croatia, India, Malaysia, North Macedonia, Romania, South Africa, Turkey (Türkiye)

Outcome results

None listed

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