Phase 3 · Liraglutide

NCT01664247 trial results

The Effect of Insulin Degludec in Combination With Liraglutide and Metformin in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification

Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%) (percentage of glycosylated haemoglobin), Week 0, week 26. IDeg: -0.99; Placebo: -0.07.

Participants: 346
Status: completed
Completed: 2013-12-31
Sponsor: Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT01664247), updated at source Sep 25, 2017. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT01664247 measured first

Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)percentage of glycosylated haemoglobin · Week 0, week 26 · least squares mean

IDegn=174	Placebon=172
-0.99(0.08)	-0.07(0.08)

Side effects by arm

Side effects in NCT01664247

Percent of participants affected, The adverse events were collected in a time frame of 26 weeks + 7 days follow up. Adverse event with an onset date on or after the first day of exposure to randomised treatment and no later than 7.... The most common events the registry lists.

Event	IDeg	Placebo
Any serious event	3.5%	5.3%
Nasopharyngitis	8.1%	6.5%
Diarrhoea	5.8%	7.6%
Lipase increased	5.8%	7.6%

Secondary outcomes

What else it measured

Change From Baseline in Fasting Plasma Glucose (FPG)mmol/L · Week 0, week 26 · mean

IDegn=172	Placebon=168
-2.60(2.91)	-0.28(2.44)

Number of Responders for HbA1c (Below 7.0 %)percentage (%) of subjects · After 26 weeks of randomised treatment. · number

IDegn=174	Placebon=172
77.6	35.5

Change From Baseline in Mean Pre-breakfast Measurements Used for Titrationmmol/L · Week 0, week 26 · least squares mean

IDegn=171	Placebon=167
5.88(0.14)	8.23(0.15)

Change From Baseline in 8-point Profilemmol/L · Week 0, week 26 · least squares mean

Measure	IDegn=172	Placebon=169
Before breakfast, N=170, 164	5.85(0.15)	8.54(0.16)
90 min after breakfast, N=153, 148	7.65(0.24)	9.75(0.25)
Before lunch, N=151,149	6.33(0.18)	8.34(0.19)
90 min after lunch, N=152,150	7.73(0.21)	9.67(0.21)
Before evening meal, N=154,148	6.77(0.20)	9.51(0.21)
90 mins after evening meal, N=147,145	7.93(0.21)	9.65(0.22)
Before bedtime, N=148, 142	7.21(0.20)	8.95(0.21)
Before breakfast the next day, N=164,161	6.05(0.17)	8.55(0.18)

Change From Baseline in Mean of the 8-point Profilemmol/L · Week 0, week 26 · mean

IDegn=169	Placebon=166
-2.3(1.8)	-0.5(1.7)

Number of Hypoglycaemic Episodesevents · Weeks 0 - 26 · number

IDegn=173	Placebon=170
47	9

Number of Adverse Eventsevents · Weeks 0 - 26 · number

IDegn=173	Placebon=170
285	252

Change From Baseline in Patient Reported Health-related Quality of Life Using the Short-Form 36 Health Survey Version 2 (SF-36®v2)T-scores · Week 0, week 26 · mean

Measure	IDegn=174	Placebon=169
Physical health	0.5(6.3)	0.0(6.2)
Mental health	0.6(8.1)	-0.7(8.8)

The trial

How NCT01664247 was run

This trial is conducted in Africa, Asia, Europe and North America. The purpose of the trial is to investigate the effect of insulin degludec (IDeg) in combination with liraglutide (Lira) and metformin (at least 1500 mg daily or maximum tolerated dose) in subjects with type 2 diabetes qualifying for treatment intensification.

IDeg + Lira
Placebo + Lira

Who could join the trial

Inclusion Criteria: * Type 2 diabetes * Insulin naïve * Ongoing treatment with metformin or metformin in combination with either sulphonylurea (SU), glinides, dipeptidyl peptidase-IV (DPP-IV) inhibitors or exenatide (only twice daily (BID)) * Glycosylated haemoglobin (HbA1c) (by central laboratory analysis): a. 7.5-10.0 % (both inclusive) for subjects on metformin monotherapy, b. 7.0-9.0 % (both inclusive) for subjects on metformin in combination with either SU, glinides, DPP-IV inhibitors or exenatide (only BID) Exclusion Criteria: * Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 12 weeks * Calcitonin equal to or above 50 pg/mL * Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within 24 weeks * Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell carcinoma)

Published papers

Papers from NCT01664247

Aroda VR, Bailey TS, Cariou B, Kumar S, Leiter LA, Raskin P, Zacho J, Andersen TH, Philis-Tsimikas A. Effect of adding insulin degludec to treatment in patients with type 2 diabetes inadequately controlled with metformin and liraglutide: a double-blind randomized controlled trial (BEGIN: ADD TO GLP-1 Study). Diabetes Obes Metab. 2016 Jul;18(7):663-70. doi: 10.1111/dom.12661. Epub 2016 May 2.

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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