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

Phase 1

• Conditions: Diabetes mellitus type 2; MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2008-001602-16-DK
• Lead Sponsor: Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-04-04
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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