Impact of Dietary Intervention on Weight Change in Subjec... | NCT01232491

ID	Type	Description	Link
U1111-1116-2629	Other Identifier	WHO
2009-014894-42	EudraCT Number

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)

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 detemir Dietary Supplement: Dietary regimen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Insulin detemir	Drug	Individually adjusted insulin detemir subcutaneously (under the skin) once daily. Subjects continue their pre-trial metformin treatment.	Control

Outcomes Module

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Change From Baseline in Body Mass Index (BMI)	Estimated mean change from baseline in BMI after 26 weeks of treatment.	Week 0, Week 26
Change From Baseline in Glycosylated Haemoglobin (HbA1c)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Global Clinical Registry Gorsøe (GCR, 1452)	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Birmingham	Alabama	35233	United States
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24112375	Background	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.

Label	URL
Clinical Trials at Novo Nordisk	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00058.2± 9.7 BG00156.5± 10.0 BG00257.4± 9.9

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000152 BG001143 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

White

Title	Measurements
	BG000274 BG001268 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Hispanic or Latino

Title	Measurements
	BG00063 BG00178 BG002

Height

Mean

Standard Deviation

meters

Title

Denominators

Categories

Title	Measurements
	BG0001.67± 0.10 BG0011.68± 0.10 BG002

Body weight

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00096.4± 18.2 BG00197.0± 20.4 BG002

Body mass index (BMI)

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00034.4± 5.4 BG00134.3± 5.6 BG002

Duration of diabetes

The number of subjects (N) analysed in the Dietician group was 303 instead of 305.

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG0008.6± 5.8 BG0018.5± 6.0

Fasting plasma glucose (FPG)

The number of subjects (N) analysed in the Control group was 298 instead of 301.

Mean

Standard Deviation

mmol/L

Title

Denominators

Categories

Title	Measurements
	BG0009.3± 2.3 BG0019.2± 2.0

Glycosylated haemoglobin (HbA1c)

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Title

Denominators

Categories

Title	Measurements
	BG0008.0± 0.7 BG0017.9± 0.6 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Body Weight

Estimated mean change from baseline in body weight after 26 weeks of treatment.

Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

Week 0, Week 26

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000306 OG001305

Title

Denominators

Categories

Title	Measurements
	OG000-1.05± 0.23 OG001-0.56± 0.23

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Normal linear regression model with treatment, strata, use of insulin secretagogue at screening, sex and region as factors and age and weight at baseline as covariates. Superiority was considered confirmed if the upper bound of the two-sided 95% CI for the estimated treatment difference (dietary intervention versus no dietary intervention), which was calculated using the FAS, was below 0 kg.	Regression, Linear		0.132	If the p-value for the two-sided test was less than 5%, and D (the estimated treatment difference [dietary intervention versus no dietary intervention]) was less than 0 then superiority for dietary intervention was considered confirmed.	Estimated treatment difference, LS Mean	0.49				95	-0.15	1.13

Secondary

Change From Baseline in Body Mass Index (BMI)

Estimated mean change from baseline in BMI after 26 weeks of treatment.

Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

kg/m^2

Week 0, Week 26

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Change From Baseline in Glycosylated Haemoglobin (HbA1c)

Estimated mean change from baseline in HbA1c after 26 weeks of treatment.

Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

percentage of glycosylated haemoglobin

Week 0, Week 26

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Change From Baseline in Fasting Plasma Glucose (FPG)

Estimated mean change from baseline in FPG after 26 weeks of treatment.

Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

mmol/L

Week 0, Week 26

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

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.

Safety analysis set includes all subjects who received at least one dose of insulin detemir.

Posted

Number

rate per 100 years of patient exposure

Week 0 to Week 26

ID	Title	Description
OG000	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.
OG001	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.

Secondary

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.

Safety analysis set includes all subjects who received at least one dose of insulin detemir.

Posted

Number

rate per year of patient exposure

Week 0 to Week 26

ID	Title	Description
OG000	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.
OG001	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.

Secondary

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.

Safety analysis set includes all subjects who received at least one dose of insulin detemir.

Posted

Number

rate per year of patient exposure

Week 0 to Week 26

ID	Title	Description
OG000	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.
OG001	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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.			17	305	61	305
EG001	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.			19	301	69	301

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute coronary syndrome	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected305 at risk EG0010 events0 affected301 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected305 at risk EG0012 events2 affected301 at risk
Angina pectoris	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected305 at risk EG0010 events0 affected301 at risk
Cardiac disorder	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected305 at risk EG0010 events0 affected301 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected305 at risk EG0011 events1 affected301 at risk
Myocardial infarction	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected305 at risk EG0011 events1 affected301 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected305 at risk EG0011 events1 affected301 at risk
Tachycardia	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected305 at risk EG0011 events1 affected301 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected305 at risk EG0011 events1 affected301 at risk
Retinal vein thrombosis	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected305 at risk EG0011 events1 affected301 at risk
Gastritis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected305 at risk EG0011 events1 affected301 at risk
Chest pain	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected305 at risk EG0011 events1 affected301 at risk
Anal abscess	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected305 at risk EG0010 events0 affected301 at risk
Bronchitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected305 at risk EG0011 events1 affected301 at risk
Bursitis infective	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected305 at risk EG0010 events0 affected301 at risk
Lobar pneumonia	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected305 at risk EG0011 events1 affected301 at risk
Pneumonia	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected305 at risk EG0010 events0 affected301 at risk
Viral infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected305 at risk EG0010 events0 affected301 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected305 at risk EG0010 events0 affected301 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected305 at risk EG0010 events0 affected301 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0002 events1 affected305 at risk EG0010 events0 affected301 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected305 at risk EG0010 events0 affected301 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected305 at risk EG0010 events0 affected301 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected305 at risk EG0011 events1 affected301 at risk
Migraine with aura	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected305 at risk EG0010 events0 affected301 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected305 at risk EG0011 events1 affected301 at risk
Depression	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected305 at risk EG0011 events1 affected301 at risk
Schizophrenia	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0003 events1 affected305 at risk EG0010 events0 affected301 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected305 at risk EG0010 events0 affected301 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected305 at risk EG0011 events1 affected301 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected305 at risk EG0011 events1 affected301 at risk
Obstructive uropathy	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected305 at risk EG0011 events1 affected301 at risk
Endometrial hypertrophy	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected305 at risk EG0011 events1 affected301 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected305 at risk EG0012 events2 affected301 at risk
Hypertension	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected305 at risk EG0011 events1 affected301 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injection site reaction	General disorders	MedDRA 14.1	Systematic Assessment	EG00021 events16 affected305 at risk EG00117 events13 affected301 at risk
Nasopharyngitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00039 events30 affected305 at risk EG00149 events38 affected301 at risk
Headache	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00029 events23 affected305 at risk EG00136 events24 affected301 at risk

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins