A Trial Comparing the Efficacy and Safety of Insulin Degl... | NCT01392573

ID	Type	Description	Link
2011-002336-72	EudraCT Number
U1111-1121-4897	Other Identifier	WHO

Status Module

Label	Type	Description	Intervention Names
IDegLira + metformin	Experimental	IDegLira was injected subcutaneously once daily for 26 weeks.	Drug: insulin degludec/liraglutide
IDeg + metformin	Experimental	IDeg was injected subcutaneously once daily for 26 weeks.	Drug: insulin degludec

Name	Type	Description	Arm Group Labels	Other Names
insulin degludec/liraglutide	Drug	IDeg/Lira treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). IDegLira is injected subcutaneously (under the skin) once daily.

Measure	Description	Time Frame
Change From Baseline in HbA1c (Glycosylated Haemoglobin)	Observed mean change from baseline in HbA1c after 26 Weeks of treatment.	Week 0, week 26

Measure	Description	Time Frame
Change in Body Weight	Observed mean change from baseline in body weight after 26 Weeks of treatment.	Week 0, week 26

Eligibility Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Huntsville	Alabama	35801	United States
Novo Nordisk Investigational Site

PubMed Identifier	Type	Citation	Retractions
28332144	Background	Khunti K, Mohan V, Jain SM, Boesgaard TW, Begtrup K, Sethi B. Efficacy and Safety of IDegLira in Participants with Type 2 Diabetes in India Uncontrolled on Oral Antidiabetic Drugs and Basal Insulin: Data from the DUAL Clinical Trial Program. Diabetes Ther. 2017 Jun;8(3):673-682. doi: 10.1007/s13300-017-0252-9. Epub 2017 Mar 22.
28063135

Label	URL
Clinical Trials at Novo Nordisk	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	IDegLira	Insulin degludec/liraglutide (IDegLira) was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast self-monitored plasma glucose (SMPG) values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	IDegLira	IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
BG001	IDeg	Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
BG002	Total	Total of all reporting groups

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 HbA1c (Glycosylated Haemoglobin)

Observed mean change from baseline in HbA1c after 26 Weeks of treatment.

Full analysis set. Missing data was imputed using last observation carried forward (LOCF).

Posted

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Week 0, week 26

ID	Title	Description
OG000	IDegLira	IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
OG001	IDeg	Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).

Units	Counts
Participants	OG000199 OG001199

Title

Denominators

Categories

Title	Measurements
	OG000-1.90± 1.09 OG001-0.89± 1.18

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		ANCOVA	ANCOVA model with treatment, country and previous antidiabetic treatment as fixed effects and baseline HbA1c value as covariate	<0.0001		Treatment contrast	-1.05			2-Sided	95	-1.25	-0.84					Superiority or Other

Secondary

Change in Body Weight

Observed mean change from baseline in body weight after 26 Weeks of treatment.

Full analysis set. Missing data was imputed using LOCF.

Posted

Mean

Standard Deviation

Week 0, week 26

ID	Title	Description
OG000	IDegLira	IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
OG001	IDeg	Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).

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	IDegLira	IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.			7	199	45	199
EG001	IDeg	Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).			11	199	29	199

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA version 15.0	Systematic Assessment	EG0001 events1 affected199 at risk EG0011 events1 affected199 at risk
Atrial fibrillation	Cardiac disorders	MedDRA version 15.0	Systematic Assessment	EG0001 events1 affected199 at risk EG0010 events0 affected199 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA version 15.0	Systematic Assessment	EG0001 events1 affected199 at risk EG0010 events0 affected199 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA version 15.0	Systematic Assessment	EG0001 events1 affected199 at risk EG0010 events0 affected199 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA version 15.0	Systematic Assessment	EG0001 events1 affected199 at risk EG0010 events0 affected199 at risk
Pneumonia	Infections and infestations	MedDRA version 15.0	Systematic Assessment	EG0001 events1 affected199 at risk EG0011 events1 affected199 at risk
Vestibular neuronitis	Infections and infestations	MedDRA version 15.0	Systematic Assessment	EG0001 events1 affected199 at risk EG0010 events0 affected199 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA version 15.0	Systematic Assessment	EG0000 events0 affected199 at risk EG0011 events1 affected199 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA version 15.0	Systematic Assessment	EG0000 events0 affected199 at risk EG0011 events1 affected199 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA version 15.0	Systematic Assessment	EG0000 events0 affected199 at risk EG0011 events1 affected199 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA version 15.0	Systematic Assessment	EG0001 events1 affected199 at risk EG0010 events0 affected199 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA version 15.0	Systematic Assessment	EG0000 events0 affected199 at risk EG0011 events1 affected199 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.0	Systematic Assessment	EG0000 events0 affected199 at risk EG0011 events1 affected199 at risk
Convulsion	Nervous system disorders	MedDRA version 15.0	Systematic Assessment	EG0000 events0 affected199 at risk EG0011 events1 affected199 at risk
Ischaemic stroke	Nervous system disorders	MedDRA version 15.0	Systematic Assessment	EG0000 events0 affected199 at risk EG0011 events1 affected199 at risk
Mononeuropathy	Nervous system disorders	MedDRA version 15.0	Systematic Assessment	EG0000 events0 affected199 at risk EG0011 events1 affected199 at risk
VIIth nerve paralysis	Nervous system disorders	MedDRA version 15.0	Systematic Assessment	EG0001 events1 affected199 at risk EG0010 events0 affected199 at risk
Vertigo CNS origin	Nervous system disorders	MedDRA version 15.0	Systematic Assessment	EG0000 events0 affected199 at risk EG0011 events1 affected199 at risk
Major depression	Psychiatric disorders	MedDRA version 15.0	Systematic Assessment	EG0001 events1 affected199 at risk EG0010 events0 affected199 at risk
Renal failure acute	Renal and urinary disorders	MedDRA version 15.0	Systematic Assessment	EG0001 events1 affected199 at risk EG0010 events0 affected199 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.0	Systematic Assessment	EG0000 events0 affected199 at risk EG0011 events1 affected199 at risk
Coronary revascularisation	Surgical and medical procedures	MedDRA version 15.0	Systematic Assessment	EG0000 events0 affected199 at risk EG0011 events1 affected199 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA version 15.0	Systematic Assessment	EG00021 events13 affected199 at risk EG0018 events7 affected199 at risk
Nausea	Gastrointestinal disorders	MedDRA version 15.0	Systematic Assessment	EG00020 events13 affected199 at risk EG0017 events7 affected199 at risk
Nasopharyngitis	Infections and infestations	MedDRA version 15.0	Systematic Assessment	EG0005 events5 affected199 at risk EG00114 events12 affected199 at risk
Lipase increased	Investigations	MedDRA version 15.0	Systematic Assessment	EG00012 events12 affected199 at risk EG0017 events7 affected199 at risk
Headache	Nervous system disorders	MedDRA version 15.0	Systematic Assessment	EG00023 events12 affected199 at risk EG0016 events4 affected199 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