DiabetesPhase 4DIET™NCT01232491
Impact of Dietary Intervention on Weight Change in Subjects With Type 2 Diabetes
A Phase 4 study testing Insulin detemir and Dietary regimen in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 112 sites in 11 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- Insulin detemir and Dietary regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 611 participants
- Where
- 112 sitesin 11 countries
- Study dates
- 29 Oct 2010to 14 Nov 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
112 sites in 11 countries.
112 sites in 11 countries
United States76 sites
Novo Nordisk Investigational Site
Altoona, Pennsylvania, 16602
Novo Nordisk Investigational Site
Anaheim, California, 92801
Novo Nordisk Investigational Site
Anderson, South Carolina, 29621
Novo Nordisk Investigational Site
Atlanta, Georgia, 30342
Novo Nordisk Investigational Site
Berlin, New Jersey, 08009
Novo Nordisk Investigational Site
Birmingham, Alabama, 35233
Novo Nordisk Investigational Site
Bradenton, Florida, 34201
Novo Nordisk Investigational Site
Bristol, Tennessee, 37620-7352
Novo Nordisk Investigational Site
Brockton, Massachusetts, 02301
Novo Nordisk Investigational Site
Buckley, Michigan, 49620
Novo Nordisk Investigational Site
Burlingame, California, 94010
Novo Nordisk Investigational Site
Charlotte, North Carolina, 28277
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37411
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45245
Novo Nordisk Investigational Site
Clearwater, Florida, 33765
Novo Nordisk Investigational Site
Colorado Springs, Colorado, 80907
Novo Nordisk Investigational Site
Concord, California, 94520
Novo Nordisk Investigational Site
Dallas, Texas, 75231
Novo Nordisk Investigational Site
Dallas, Texas, 75246
Novo Nordisk Investigational Site
Dallas, Texas, 75251
Novo Nordisk Investigational Site
Dayton, Ohio, 45406
Novo Nordisk Investigational Site
Dayton, Ohio, 45439
Novo Nordisk Investigational Site
Durham, North Carolina, 27710
Novo Nordisk Investigational Site
Evansville, Indiana, 47714
Novo Nordisk Investigational Site
Fullerton, California, 92835
Novo Nordisk Investigational Site
Greer, South Carolina, 29651
Novo Nordisk Investigational Site
Jacksonville, Florida, 32204
Novo Nordisk Investigational Site
Jacksonville, Florida, 32207
Novo Nordisk Investigational Site
Jenkintown, Pennsylvania, 19046
Novo Nordisk Investigational Site
Jupiter, Florida, 33458
Novo Nordisk Investigational Site
Kingsport, Tennessee, 37660
Novo Nordisk Investigational Site
Long Beach, California, 90806
Novo Nordisk Investigational Site
Long Beach, California, 90807
Novo Nordisk Investigational Site
Long Beach, California, 90822
Novo Nordisk Investigational Site
Louisville, Kentucky, 40213
Novo Nordisk Investigational Site
Martinsburg, West Virginia, 25401
Novo Nordisk Investigational Site
Miami, Florida, 33135
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, 53209
Novo Nordisk Investigational Site
Montclair, California, 91763
Novo Nordisk Investigational Site
Nashville, Tennessee, 37212
Novo Nordisk Investigational Site
National City, California, 91950
Novo Nordisk Investigational Site
New York, New York, 10025
Novo Nordisk Investigational Site
Norfolk, Virginia, 23502
Novo Nordisk Investigational Site
Norristown, Pennsylvania, 19401
Novo Nordisk Investigational Site
Northport, New York, 11768
Novo Nordisk Investigational Site
Norwalk, Connecticut, 06851
Novo Nordisk Investigational Site
Odessa, Texas, 79761
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, 73103
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, 73104-5020
Novo Nordisk Investigational Site
Oympiafields, Illinois, 60641
Novo Nordisk Investigational Site
Ozark, Alabama, 36360
Novo Nordisk Investigational Site
Pembroke Pines, Florida, 33027
Novo Nordisk Investigational Site
Pembroke Pines, Florida, 33028
Novo Nordisk Investigational Site
Pembroke Pines, Florida, 33029
Novo Nordisk Investigational Site
Perry, Georgia, 31069
Novo Nordisk Investigational Site
Plano, Texas, 75075
Novo Nordisk Investigational Site
Portland, Maine, 04101
Novo Nordisk Investigational Site
Raleigh, North Carolina, 27609
Novo Nordisk Investigational Site
Rapid City, South Dakota, 57701
Novo Nordisk Investigational Site
Redlands, California, 92374
Novo Nordisk Investigational Site
Richmond, Virginia, 23249
Novo Nordisk Investigational Site
Richmond, Virginia, 23294
Novo Nordisk Investigational Site
Rockville, Maryland, 20852
Novo Nordisk Investigational Site
Roswell, Georgia, 30076
Novo Nordisk Investigational Site
Santa Ana, California, 92705
Novo Nordisk Investigational Site
Shawnee Mission, Kansas, 66204
Novo Nordisk Investigational Site
Southfield, Michigan, 48034
Novo Nordisk Investigational Site
Spokane, Washington, 99208
Novo Nordisk Investigational Site
Spring Valley, California, 91978
Novo Nordisk Investigational Site
St Louis, Missouri, 63141
Novo Nordisk Investigational Site
St. George, Utah, 84790
Novo Nordisk Investigational Site
Topeka, Kansas, 66606
Novo Nordisk Investigational Site
Walnut Creek, California, 94598
Novo Nordisk Investigational Site
West Seneca, New York, 14224
Novo Nordisk Investigational Site
Wilmington, North Carolina, 28401
Novo Nordisk Investigational Site
Winchester, Virginia, 22601
Germany7 sites
Novo Nordisk Investigational Site
Bad Neuenahr-Ahrweiler, 53474
Novo Nordisk Investigational Site
Gelnhausen, 63571
Novo Nordisk Investigational Site
Mainz, 55116
Novo Nordisk Investigational Site
Marburg, 35039
Novo Nordisk Investigational Site
Rehlingen-Siersburg, 66780
Novo Nordisk Investigational Site
Saint Ingbert, 66386
Novo Nordisk Investigational Site
Völklingen, 66333
Argentina5 sites
Novo Nordisk Investigational Site
Buenos Aires, B1636DSU
Novo Nordisk Investigational Site
Caba, C1419AHN
Novo Nordisk Investigational Site
Capital Federal, 1429
Novo Nordisk Investigational Site
Córdoba, 5000
Novo Nordisk Investigational Site
Godoy Cruz, M5501ARP
Turkey (Türkiye)5 sites
Novo Nordisk Investigational Site
Ankara, 06110
Novo Nordisk Investigational Site
Istanbul, 34096
Novo Nordisk Investigational Site
Istanbul, 34098
Novo Nordisk Investigational Site
Istanbul, 34722
Novo Nordisk Investigational Site
Samsun, 55139
Poland4 sites
Novo Nordisk Investigational Site
Bialystok, 15-445
Novo Nordisk Investigational Site
Lublin, 20-044
Novo Nordisk Investigational Site
Torun, 87-100
Novo Nordisk Investigational Site
Warsaw, 00-911
Russia3 sites
Novo Nordisk Investigational Site
Saint Petersburg, 194358
Novo Nordisk Investigational Site
Saint Petersburg, 195213
Novo Nordisk Investigational Site
Saint Petersburg, 199034
Slovakia3 sites
Novo Nordisk Investigational Site
Bratislava, 851 01
Novo Nordisk Investigational Site
Košice, 04-001
Novo Nordisk Investigational Site
Ľubochňa, 03491
Slovenia3 sites
Novo Nordisk Investigational Site
Koper, SI-6000
Novo Nordisk Investigational Site
Maribor, 2000
Novo Nordisk Investigational Site
Novo Mesto, 8000
Spain3 sites
Novo Nordisk Investigational Site
Málaga, 29006
Novo Nordisk Investigational Site
Málaga, 29009
Novo Nordisk Investigational Site
Sanlúcar de Barrameda, 11540
Puerto Rico2 sites
Novo Nordisk Investigational Site
Carolina, 00983
Novo Nordisk Investigational Site
Manati, 00674
About this study
Official title: A 26-week Randomised, Controlled, Open Label, Multicentre, Multinational, Treat to Target Trial Investigating the Impact of Dietary Intervention on Weight Change and the Relationship Between Weight Change and Baseline Body Mass Index (BMI) in Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs) Initiating Insulin Therapy With Insulin Detemir in Combination With Metformin (Levemir DIET)
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
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- Insulin detemir, Dietary regimen
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin detemirDrug
Individually adjusted insulin detemir subcutaneously (under the skin) once daily. Subjects continue their pre-trial metformin treatment.
Dietary regimenDietary supplement
Subjects receive dietary consultation by a dietician at six occasions during the trial.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 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. Receives: Drug: Insulin detemir |
| Dietician | Experimental | 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. Receives: Drug: Insulin detemir; Dietary Supplement: Dietary regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Body Weight
Estimated mean change from baseline in body weight after 26 weeks of treatment.
Measured: Week 0, Week 26
Secondary outcomes (6)
Change From Baseline in Body Mass Index (BMI)
Estimated mean change from baseline in BMI after 26 weeks of treatment.
Measured: Week 0, Week 26
Change From Baseline in Glycosylated Haemoglobin (HbA1c)
Estimated mean change from baseline in HbA1c after 26 weeks of treatment.
Measured: Week 0, Week 26
Change From Baseline in Fasting Plasma Glucose (FPG)
Estimated mean change from baseline in FPG after 26 weeks of treatment.
Measured: Week 0, Week 26
Rate of Treatment Emergent Adverse Events (TEAEs)
Corresponds to rate of adverse events (AEs) per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious AEs: AEs that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, persistent/significant disability/incapacity/congenital anomaly/birth defect.
Measured: Week 0 to Week 26
Rate of All Treatment Emergent Hypoglycaemic Episodes
Corresponds to rate of treatment emergent hypoglycaemic episodes per patient exposure year. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. Severe, if assistance was required to actively administer carbohydrate, glucagons or other resuscitative actions.
Measured: Week 0 to Week 26
Rate of Nocturnal Treatment Emergent Hypoglycaemic Episodes
Corresponds to rate of treatment emergent hypoglycaemic episodes per patient exposure year. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. A hypoglycaemic episode with time of onset between 00:01 and 05:59 a.m. (both included) was considered nocturnal. Severe, if assistance was required to actively administer carbohydrate, glucagons or other resuscitative actions.
Measured: Week 0 to Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study start29 Oct 2010
- Primary completion1 Nov 2011
- Study completion14 Nov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 611 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry Gorsøe (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232491
- Sponsor's protocol ID
- NN304-3785
- Other IDs
- U1111-1116-2629, 2009-014894-42, 2009
- Acronym
- DIET™
- Status last verified
- Mar 2017
- First submitted
- 29 Oct 2010
- Last updated
- 1 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24112375
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 26-week Randomised, Controlled, Open Label, Multicentre, Multinational, Treat to Target Trial Investigating the Impact of Dietary Intervention on Weight Change and the Relationship Between Weight Change and Baseline Body Mass Index (BMI) in Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs) Initiating Insulin Therapy With Insulin Detemir in Combination With Metformin (Levemir DIET)
- ClinicalTrials.gov ID
- NCT01232491
- Acronym / sponsor ID
- DIET™ / NN304-3785
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 611 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2010 (actual)
- Primary completion
- 1 Nov 2011 (actual)
- Study completion
- 14 Nov 2011 (actual)
- First posted
- 2 Nov 2010 (estimated)
- Results
- Posted 11 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Insulin detemirInsulin 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. |
| Dietician | Experimental | Drug: Insulin detemir, Dietary Supplement: Dietary regimenInsulin 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin detemirIndividually adjusted insulin detemir subcutaneously (under the skin) once daily. Subjects continue their pre-trial metformin treatment. | Drug | Control, Dietician |
| Dietary regimenSubjects receive dietary consultation by a dietician at six occasions during the trial. | Dietary supplement | Dietician |
Primary outcome
Change From Baseline in Body Weight
Time frame: Week 0, Week 26
Estimated mean change from baseline in body weight after 26 weeks of treatment.
6 secondary outcomes
Change From Baseline in Body Mass Index (BMI)
Time frame: Week 0, Week 26
Change From Baseline in Glycosylated Haemoglobin (HbA1c)
Time frame: Week 0, Week 26
Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame: Week 0, Week 26
Rate of Treatment Emergent Adverse Events (TEAEs)
Time frame: Week 0 to Week 26
Rate of All Treatment Emergent Hypoglycaemic Episodes
Time frame: Week 0 to Week 26
Rate of Nocturnal Treatment Emergent Hypoglycaemic Episodes
Time frame: Week 0 to Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24112375Niswender 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.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry Gorsøe (GCR, 1452) study director
Novo Nordisk A/S
112 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin detemir and Dietary regimen in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 112 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 112 sites in United States, Germany, Argentina, Turkey (Türkiye), Poland and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Body Weight (time frame: Week 0, Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01232491, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2017.