Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening in Patients With Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes

• Registration Number: NCT00104182
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the use of Insulin Detemir once a day (morning or evening) to NPH Insulin once a day (evening) when added to treatment with oral antidiabetic drugs in patients with Type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-02-23
• Study First Submitted QC: 2005-02-23
• Study First Posted: 2005-02-24
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-27
• Last Update Posted: 2017-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 503

Inclusion Criteria

• Type 2 diabetes for at least 12 months
• Currently treated with Oral Antidiabetic Drugs
• BMI lesser than or equal to 40 kg/m2
• HbA1c greater than or equal 7.5 and lesser than or equal to 11%

Exclusion Criteria

• Proliferative retinopathy or maculopathy
• Recurrent major hypoglycaemia
• uncontrolled hypertension or any disease or condition (such as renal, hepatic or cardiac) that according to the judgement of the Investigator makes the subject unsuitable for participation in the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1C	after 20 weeks

Secondary Outcome Measures

Name	Time	Method
Hypoglycemia
Blood glucose
Adverse events
body weight

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇪🇸 Valladolid, Spain