Pharmacodynamics and Pharmacokinetics of Insulin Detemir in Subjects With Type 2 Diabetes

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin NPH; Drug: insulin detemir

• Registration Number: NCT01497561
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamics and pharmacokinetics of single doses of insulin detemir and insulin NPH in subjects with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Primary Completion: 2003-06
• Study Completion: 2003-06
• Study First Submitted: 2011-12-20
• Study First Submitted QC: 2011-12-20
• Study First Posted: 2011-12-22
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-26
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Type 2 diabetes
• Subjects treated with insulin for minimum 3 months
• Duration of diabetes for at least 12 months
• Body Mass Index (BMI) below 30 kg/m^2
• HbA1c maximum 10% based on analysis from central laboratory

Exclusion Criteria

• Current treatment with insulin above 1.2 U/kg/day
• Current treatment with insulin glargine
• Current treatment with drugs known to interfere with glucose metabolism
• Current treatment with oral antidiabetic drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
insulin NPH	insulin NPH	-
insulin detemir	insulin detemir	-

Primary Outcome Measures

Name	Time	Method
Area under the glucose infusion rate curve

Secondary Outcome Measures

Name	Time	Method
Maximum glucose infusion rate
Maximum concentration
Time to maximum concentration
Insulin clearance
Mean residence time of insulin
Terminal rate constant
Terminal half-life
Time to maximum glucose
Area under the curve

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Graz, Germany