Comparison of Insulin Detemir Versus Insulin NPH on Weight Change in Overweight and Obese With Type 2 Diabetes (PREDICTIVE™)

October 31, 2023 updated by: Novo Nordisk A/S

Comparison of the Effect of Insulin Detemir Versus Insulin NPH Both With Insulin Aspart on Weight Change in Overweight and Obese Subjects With Type 2 Diabetes

This trial is conducted in Europe. The purpose of the trial is to investigate the effect of insulin detemir on weight change in overweight and obese patients with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

277

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Spain
- - La Coruña, Spain, 15006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

HbA1c: 7.5-11.0%
BMI: 25-40 kg/m2

Exclusion Criteria:

Treatment with any OAD (Oral Antidiabetic Drugs) except metformin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Body weight loss Time Frame: after 26 weeks of treatment	after 26 weeks of treatment

Secondary Outcome Measures

Outcome Measure
HbA1c
Incidence of hypoglycaemia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Clinical Trials at Novo Nordisk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)