Comparison of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs, in Subjects With Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin glargine; Drug: insulin degludec/insulin aspart

• Registration Number: NCT01045447
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with insulin glargine in patients with type 2 diabetes inadequately controlled with insulin and oral anti-diabetic drugs (OADs). Subjects continued their ongoing treatment with OADs in the trial.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-08
• Study First Submitted QC: 2010-01-08
• Study First Posted: 2010-01-11
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Disposition First Submitted: 2011-02-24
• Disposition First Submitted QC: 2011-02-24
• Disposition First Posted: 2011-03-09
• Results First Submitted: 2015-10-19
• Results First Submitted QC: 2015-10-19
• Results First Posted: 2015-11-18
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 465

Inclusion Criteria

• Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
• Treatment with basal insulin regimen (insulin detemir, insulin glargine or neutral protamine Hagedorn [NPH] insulin) once daily (OD), for at least 3 months
• Ongoing treatment with: metformin with or without other oral antidiabetic drugs (OADs) for at least 3 months prior to randomisation
• HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
• BMI maximum 40.0 kg/m^2

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Exclusion Criteria

• Treatment with insulin regimens other than a basal insulin regimen (insulin detemir or insulin glargine or NPH insulin) OD within 3 months prior to Visit 1
• Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists within 3 months prior to visit 1
• Current rosiglitazone users
• Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
• Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
• Impaired liver function, defined as alanine aminotransferase (ALAT) at least 2.5 times upper limit of normal (one retest analysed at the central laboratory within a week of receipt of the result is permitted with the result of the last sample being conclusive)
• Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
• Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IGlar OD	insulin glargine	-
IDegAsp OD	insulin degludec/insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Change in Glycosylated Haemoglobin (HbA1c)	Week 0, Week 26	Change from baseline in HbA1c after 26 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)	Week 26	Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇹🇷 Kahramanmaras, Turkey