NCT01232491|CompletedPhase 4Results

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

DIET™

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)

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN304-3785U1111-1116-26292009-014894-42

Study Type

interventional

Target

611

Locations

10 countries

Sites

109

Timeline

RegisteredNov 2010

StartedOct 2010

CompletionNov 2011

Brief 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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

611

participants targeted

Target at P75+ for phase_4 diabetes

Timeline

Completed

Started Oct 2010

Geographic Reach

10 countries

109 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1 year study duration

First Submitted

Initial submission to the registry

October 29, 2010

Completed

Same day until next milestone

Study Start

First participant enrolled

October 29, 2010

Completed

4 days until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed

13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2011

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

December 11, 2012

Completed

Last Updated

May 1, 2017

Status Verified

March 1, 2017

Enrollment Period

1 year

First QC Date

October 29, 2010

Results QC Date

November 14, 2012

Last Update Submit

March 28, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change From Baseline in Body Weight
Estimated mean change from baseline in body weight after 26 weeks of treatment.
Week 0, Week 26

Secondary Outcomes (6)

Change From Baseline in Body Mass Index (BMI)
Week 0, Week 26
Change From Baseline in Glycosylated Haemoglobin (HbA1c)
Week 0, Week 26
Change From Baseline in Fasting Plasma Glucose (FPG)
Week 0, Week 26
Rate of Treatment Emergent Adverse Events (TEAEs)
Week 0 to Week 26
Rate of All Treatment Emergent Hypoglycaemic Episodes
Week 0 to Week 26
+1 more secondary outcomes

Study Arms (2)

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.

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.

Drug: Insulin detemirDietary Supplement: Dietary regimen

Interventions

Insulin detemirDRUG

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

ControlDietician

Dietary regimenDIETARY_SUPPLEMENT

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

Dietician

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)

You may not qualify if:

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

Contact the study team to confirm eligibility.