A Clinical Trial Comparing Efficacy and Safety of Insulin... | NCT02298192

ID	Type	Description	Link
2012-004625-25	EudraCT Number
U1111-1135-6634	Other Identifier	WHO

Status Module

Label	Type	Description	Intervention Names
Once weekly titration	Experimental		Drug: insulin degludec/liraglutide
Twice weekly titration	Experimental		Drug: insulin degludec/liraglutide

Name	Type	Description	Arm Group Labels	Other Names
insulin degludec/liraglutide	Drug	For subcutaneous (s.c., under the skin) injection, once daily. Subjects will be instructed to continue with the same dose of OADs (metformin alone or in combination with pioglitazone), as prior to the trial.

Measure	Description	Time Frame
Change From Baseline in HbA1c	Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline after 32 weeks of treatment.	Week 0, week 32

Measure	Description	Time Frame
HbA1c Below 7.0%	Responders to HbA1c below 7% after 32 weeks of treatment.	Week 0, week 32
HbA1c Below or Equal to 6.5%	Responders to HbA1c below or equal to 6.5% after 32 weeks of treatment.

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		Hamilton	Alabama	35570	United States
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	Safety and Efficacy of Insulin Degludec/Liraglutide(IDegLira) Titrated Once Weekly (1 Wk) vs. Twice Weekly (2 Wk) in Patients (pts) with T2D Uncontrolled on Oral Antidiabetic Drugs: DUAL VI Study; Stewart B. Harris et al. American Diabetes Association - 76th Annual Scientific Sessions; 10 June 2016
28124817	Result	Harris SB, Kocsis G, Prager R, Ridge T, Chandarana K, Halladin N, Jabbour S. Safety and efficacy of IDegLira titrated once weekly versus twice weekly in patients with type 2 diabetes uncontrolled on oral antidiabetic drugs: DUAL VI randomized clinical trial. Diabetes Obes Metab. 2017 Jun;19(6):858-865. doi: 10.1111/dom.12892. Epub 2017 Mar 3.

Label	URL
Clinical Trials at Novo Nordisk	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	IDegLira (1WT)	Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	IDegLira (1WT)	Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
BG001	IDegLira	Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
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

Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline after 32 weeks of treatment.

Full analysis set (FAS) included all randomised subjects. 20 subjects in the IDegLira (1WT) and 10 subjects in the IDegLira arm did not contribute to the analysis for this endpoint.

Posted

Mean

Standard Deviation

percentage

Week 0, week 32

ID	Title	Description
OG000	IDegLira (1WT)	Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
OG001	IDegLira	Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.

Units	Counts
Participants	OG000189 OG001200

Title

Denominators

Categories

Title	Measurements
	OG000-2.01± 1.09 OG001-2.02± 0.98

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	The null hypothesis was tested against the alternative hypothesis of non-inferiority as given by H0: D ≥0.30% against HA: D <0.30%.	Mixed Models Analysis		0.012		Treatment Contrast	0.12			2-Sided	95	-0.04	0.28					Non-Inferiority or Equivalence	The null hypothesis was tested against the alternative hypothesis of non-inferiority as given by H0: D ≥0.30% against HA: D <0.30%.

Secondary

HbA1c Below 7.0%

Responders to HbA1c below 7% after 32 weeks of treatment.

Full analysis set (FAS) included all randomised subjects. 20 subjects in the IDegLira (1WT) and 10 subjects in the IDegLira arm did not contribute to the analysis for this endpoint.

Posted

Number

participants

Week 0, week 32

ID	Title	Description
OG000	IDegLira (1WT)	Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
OG001	IDegLira	Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.

Secondary

HbA1c Below or Equal to 6.5%

Responders to HbA1c below or equal to 6.5% after 32 weeks of treatment.

Full analysis set (FAS) included all randomised subjects. 20 subjects in the IDegLira (1WT) and 10 subjects in the IDegLira arm did not contribute to the analysis for this endpoint.

Posted

Number

particpants

Week 0, week 32

ID	Title	Description
OG000	IDegLira (1WT)	Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
OG001	IDegLira	Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.

Secondary

Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

An episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.

Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation "as treated". One subject in the IDegLira (1WT) arm did not contribute to the analysis for this endpoint.

Posted

Number

Number of episodes

Week 0-32

ID	Title	Description
OG000	IDegLira (1WT)	Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
OG001	IDegLira	Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.

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 (1WT)	Subjects received IDegLira once weekly in combination with metformin alone or in combination with pioglitazone in a 1:1 manner at visit 2 and were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), and the maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).The daily dose for metformin (≥1500 mg or max tolerated dose) and pioglitazone (≥30 mg) The dose of IDegLira was to be adjusted once weekly based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on the titration day. The first dose of trial product was to be administered either on the day of randomisation (visit 2) or the day after.			7	209	24	209
EG001	IDegLira	Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.			14	210	19	210

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Appendicitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected209 at risk EG0012 events2 affected210 at risk
Atrial fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected209 at risk EG0011 events1 affected210 at risk
Blood glucose increased	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected209 at risk EG0011 events1 affected210 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected209 at risk EG0011 events1 affected210 at risk
Cholecystitis infective	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected209 at risk EG0011 events1 affected210 at risk
Circulatory collapse	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected209 at risk EG0011 events1 affected210 at risk
Colitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected209 at risk EG0010 events0 affected210 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected209 at risk EG0010 events0 affected210 at risk
Enteritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected209 at risk EG0010 events0 affected210 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected209 at risk EG0011 events1 affected210 at risk
Haematuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected209 at risk EG0011 events1 affected210 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected209 at risk EG0010 events0 affected210 at risk
Hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected209 at risk EG0010 events0 affected210 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected209 at risk EG0011 events1 affected210 at risk
Migraine	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected209 at risk EG0010 events0 affected210 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected209 at risk EG0012 events2 affected210 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected209 at risk EG0010 events0 affected210 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA	Systematic Assessment	EG0002 events1 affected209 at risk EG0010 events0 affected210 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected209 at risk EG0011 events1 affected210 at risk
Post procedural infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected209 at risk EG0011 events1 affected210 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected209 at risk EG0011 events1 affected210 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected209 at risk EG0010 events0 affected210 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected209 at risk EG0011 events1 affected210 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected209 at risk EG0011 events1 affected210 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

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment		EG00016 events13 affected209 at risk EG00113 events9 affected210 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment		EG00016 events11 affected209 at risk EG00120 events11 affected210 at risk