A Trial Comparing the Efficacy, Patient-reported Outcomes and Safety of Insulin Degludec 200 U/mL vs Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Requiring High-dose Insulin

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin degludec; Drug: insulin glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01570751

NN1250-3943

U1111-1123-4774 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in the United States of America (USA). The aim of the trial is to confirm the efficacy of IDeg (insulin degludec) versus IGlar (insulin glargine) in controlling glycaemia. Subjects are to continue their pre-trial metformin treatment.

Enrollment: 145 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• Current treatment with once daily insulin glargine in vials with a daily dose equal to or above 65 U and equal to or below 100 U
• Current treatment with a stable dose of metformin plus/minus one additional oral antidiabetic drug (OAD) for at least 12 weeks
• Glycosylated haemoglobin (HbA1c) equal to or above 7.5%

Exclusion criteria

• Current treatment with insulin other than insulin glargine in vials
• Treatment with thiazolidinediones or glucagon-like peptide-1 (GLP-1) receptor agonists within 12 weeks
• Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty
• Suffer from cancer (except basal cell skin cancer and squamous-cell cancer)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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145 participants in 2 patient groups

IDeg followed by IGlar

Experimental group

Treatment:

Drug: insulin degludec

Drug: insulin glargine

IGlar followed by IDeg

Experimental group

Treatment:

Drug: insulin degludec

Drug: insulin glargine