Effects of Insulin Levemir and Insulin Insulatard on renal handling of sodium, fluid retention and weight in type 2 diabetic patients - Weight gain during insulin treatment

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-001602-16-DK

Enrollment

Registered

2008-04-04

Start date

2008-05-13

Completion date

Unknown

Last updated

2021-08-02

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

Conditions

Diabetes mellitus type 2 MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus

Interventions

Trade Name: Insulin Levemir and Insulin Insulatard Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type 2 diabetes, age 18-80 years, HbA1c below 10% Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Serum creatinine > 130 micromol/l, urinary albumin above 30 mg/24h, pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: Efficacy of shifting insulin treatment from Insulin Insulatard to Insulin Levemir in type 2 diabetic patient on body weight and extracellular volume.;Secondary Objective: Secondary end-points are urinary sodium excretion, 24-h blood pressure, body composition and glomerular filtration rate.;Primary end point(s): Extracellular volume, body weight	—

Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026