Safety of Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus

A Multicentre, Open Label, Nonrandomised, Safety Study in Subjects Using Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus

Sponsors

Lead Sponsor: Novo Nordisk A/S

Source Novo Nordisk A/S
Brief Summary

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.

Overall Status Completed
Start Date October 2005
Completion Date April 2006
Primary Completion Date April 2006
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemic events
Secondary Outcome
Measure Time Frame
Number of adverse events (all and serious)
Number of all hypoglycaemic events
Change in weight
HbA1c (glycosylated haemoglobin)
Treatment satisfaction as assessed by Insulin Treatment Satisfaction Questionnaire (ITSQ-22)
Enrollment 2287
Condition
Intervention

Intervention Type: Drug

Intervention Name: insulin detemir

Description: Administered subcutaneously (s.c., under the skin). Dose individually adjusted.

Arm Group Label: Insulin detemir

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Global Clinical Registry (GCR, 1452) Study Director Novo Nordisk A/S
Location
Facility:
Location Countries

Canada

Verification Date

March 2016

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Insulin detemir

Type: Experimental

Acronym PREDICTIVE™
Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov