Safety of Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus (PREDICTIVE™)

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin detemir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01709929

NN304-1713

Details and patient eligibility

About

This trial is conducted in North America. The aim of this trial is to evaluate the safety of insulin detemir for the treatment of diabetes.

Enrollment: 2,287 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with type 1 or type 2 diabetes
• Using a basal/bolus insulin regimen

Exclusion criteria

• Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
• Subjects who previously enrolled in this study
• Subjects with a hypersensitivity to insulin detemir or to any of the excipients

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,287 participants in 1 patient group

Insulin detemir

Experimental group

Treatment:

Drug: insulin detemir