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

NCT ID: NCT01232491

Last Updated: 2017-05-01

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

611 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-29

Study Completion Date

2011-11-14

Brief Summary

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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).

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.

Group Type ACTIVE_COMPARATOR

Insulin detemir

Intervention Type DRUG

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

Dietician

Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.

Group Type EXPERIMENTAL

Insulin detemir

Intervention Type DRUG

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

Dietary regimen

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Insulin detemir

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

Intervention Type DRUG

Dietary regimen

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes (diagnosed clinically) for at least 6 months prior trial start
* Insulin naive subjects
* HbA1c: 7.0-9.0 % (both inclusive)
* Body Mass Index (BMI): 25.0-45.0 kg/m\^2 (both inclusive)

Exclusion Criteria

* Use of Thiazolidinedione (TZDs) or Glucagon-like peptide-1 analogue (GLP- 1) receptor agonists within the last 3 months prior to trial enrollment
* Cardiovascular disease within the last 6 months
* Recurrent severe hypoglycaemia or hypoglycaemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
* Uncontrolled treated/untreated severe hypertension, impaired liver function, impaired renal function, known proliferative retinopathy or maculopathy requiring treatment
* Cancer and medical history of cancer in the past 5 years (except basal cell skin cancer or squamous cell skin cancer)
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry Gorsøe (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Birmingham, Alabama, United States

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Ozark, Alabama, United States

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Anaheim, California, United States

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Burlingame, California, United States

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Concord, California, United States

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Fullerton, California, United States

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Long Beach, California, United States

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Long Beach, California, United States

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Long Beach, California, United States

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Montclair, California, United States

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National City, California, United States

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Redlands, California, United States

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Santa Ana, California, United States

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Spring Valley, California, United States

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Walnut Creek, California, United States

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Colorado Springs, Colorado, United States

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Norwalk, Connecticut, United States

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Bradenton, Florida, United States

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Clearwater, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Jupiter, Florida, United States

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Miami, Florida, United States

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Pembroke Pines, Florida, United States

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Pembroke Pines, Florida, United States

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Pembroke Pines, Florida, United States

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Atlanta, Georgia, United States

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Perry, Georgia, United States

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Roswell, Georgia, United States

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Oympiafields, Illinois, United States

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Evansville, Indiana, United States

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Shawnee Mission, Kansas, United States

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Topeka, Kansas, United States

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Louisville, Kentucky, United States

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Portland, Maine, United States

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Rockville, Maryland, United States

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Brockton, Massachusetts, United States

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Buckley, Michigan, United States

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Southfield, Michigan, United States

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St Louis, Missouri, United States

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Berlin, New Jersey, United States

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New York, New York, United States

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Northport, New York, United States

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West Seneca, New York, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Raleigh, North Carolina, United States

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Wilmington, North Carolina, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Dayton, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Altoona, Pennsylvania, United States

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Jenkintown, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Anderson, South Carolina, United States

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Greer, South Carolina, United States

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Rapid City, South Dakota, United States

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Bristol, Tennessee, United States

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Chattanooga, Tennessee, United States

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Kingsport, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Odessa, Texas, United States

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Plano, Texas, United States

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St. George, Utah, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Winchester, Virginia, United States

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Spokane, Washington, United States

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Martinsburg, West Virginia, United States

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Milwaukee, Wisconsin, United States

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Buenos Aires, , Argentina

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Caba, , Argentina

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Capital Federal, , Argentina

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Córdoba, , Argentina

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Godoy Cruz, , Argentina

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Bad Neuenahr-Ahrweiler, , Germany

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Gelnhausen, , Germany

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Mainz, , Germany

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Marburg, , Germany

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Rehlingen-Siersburg, , Germany

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Saint Ingbert, , Germany

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Völklingen, , Germany

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Bialystok, , Poland

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Lublin, , Poland

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Torun, , Poland

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Warsaw, , Poland

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Carolina, , Puerto Rico

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Manatí, , Puerto Rico

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Belgrade, , Serbia

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Bratislava, , Slovakia

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Košice, , Slovakia

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Ľubochňa, , Slovakia

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Koper, , Slovenia

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Maribor, , Slovenia

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Novo Mesto, , Slovenia

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Málaga, , Spain

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Málaga, , Spain

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Sanlúcar de Barrameda, , Spain

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Ankara, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Samsun, , Turkey (Türkiye)

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Countries

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

References

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Niswender K, Piletic M, Andersen H, Conradsen Hiort L, Hollander P. Weight change upon once-daily initiation of insulin detemir with or without dietary intervention in overweight or obese insulin-naive individuals with type 2 diabetes: results from the DIET trial. Diabetes Obes Metab. 2014 Feb;16(2):186-92. doi: 10.1111/dom.12218. Epub 2013 Oct 29.

Reference Type BACKGROUND
PMID: 24112375 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1116-2629

Identifier Type: OTHER

Identifier Source: secondary_id

2009-014894-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN304-3785

Identifier Type: -

Identifier Source: org_study_id

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