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Impact of Dietary Intervention on Weight Change in Subjects With Type 2 Diabetes

NCT01232491 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 611

Last updated 2017-05-01

Study results available
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Summary

This trial is conducted in Europe, and North and South America. The aim of this trial is to investigate if a dietary intervention has an effect on weight when initiating insulin treatment in subjects with type 2 diabetes currently treated with oral antidiabetic drugs (OADs).

Conditions

Interventions

DRUG

Insulin detemir

Individually adjusted insulin detemir subcutaneously (under the skin) once daily. Subjects continue their pre-trial metformin treatment.

DIETARY_SUPPLEMENT

Dietary regimen

Subjects receive dietary consultation by a dietician at six occasions during the trial.

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry Gorsøe (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-29
Primary Completion
2011-11-01
Completion
2011-11-14

Countries

  • United States
  • Argentina
  • Germany
  • Poland
  • Puerto Rico
  • Russia
  • Serbia
  • Slovakia
  • Slovenia
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01232491 on ClinicalTrials.gov