Phase 3 · Liraglutide

NCT01572740 trial results

A 36-week, Randomised, Multi-centre, Double-blind, Parallel Group Trial to Investigate the Efficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Monotherapy in Japanese Subjects With Type 2 Diabetes Mellitus

Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16 (percentage of glycosylated haemoglobin), Week 0, Week 16. Lira + Insulin: -1.73; Placebo + Insulin: -0.43.

Participants: 257
Status: completed
Completed: 2013-03-27
Sponsor: Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT01572740), updated at source Feb 7, 2018. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT01572740 measured first

Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16percentage of glycosylated haemoglobin · Week 0, Week 16 · mean

Lira + Insulinn=127	Placebo + Insulinn=129
-1.73(0.06)	-0.43(0.06)

Side effects by arm

Side effects in NCT01572740

Percent of participants affected, Adverse events were collected in a timeframe of 36 weeks + 7 days follow up.. The most common events the registry lists.

Event	Lira + Insulin	Placebo + Insulin
Any serious event	4.7%	3.1%
Nasopharyngitis	43.3%	30.8%
Constipation	11.8%	1.5%
Diarrhoea	11.8%	3.1%
Nausea	11%	5.4%
Diabetic retinopathy	7.1%	10%
Headache	6.3%	4.6%
Hypertension	6.3%	4.6%
Dyspepsia	5.5%	0%
Gastroenteritis	3.1%	5.4%
Back pain	4.7%	5.4%

Secondary outcomes

What else it measured

Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 36percentage of glycosylated haemoglobin · Week 0, Week 36 · mean

Lira + Insulinn=127	Placebo + Insulinn=129
-1.68(0.06)	-0.88(0.06)

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16mmol/L · Week 0, Week 16 · mean

Lira + Insulinn=127	Placebo + Insulinn=129
-1.31(0.17)	-0.48(0.17)

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 36mmol/L · Week 0, Week 36 · mean

Lira + Insulinn=127	Placebo + Insulinn=129
-1.55(0.16)	-1.29(0.16)

Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 16mmol/L · Week 0, Week 16 · mean

Lira + Insulinn=124	Placebo + Insulinn=124
-2.41(0.18)	-0.53(0.18)

Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 36mmol/L · Week 0, Week 36 · mean

Lira + Insulinn=124	Placebo + Insulinn=125
-2.65(0.16)	-1.37(0.16)

Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 16mmol/L · Week 0, Week 16 · mean

Lira + Insulinn=124	Placebo + Insulinn=124
-1.34(0.17)	-0.61(0.17)

Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 36mmol/L · Week 0, Week 36 · mean

Lira + Insulinn=122	Placebo + Insulinn=122
-1.34(0.21)	-0.94(0.21)

Change in Body Weight From Baseline to Week 16kg · Week 0, Week 16 · mean

Lira + Insulinn=127	Placebo + Insulinn=129
-0.42(0.14)	-0.28(0.14)

Change in Body Weight From Baseline to Week 36kg · Week 0, Week 36 · mean

Lira + Insulinn=127	Placebo + Insulinn=129
0.17(0.20)	0.52(0.20)

Number of Adverse Events (AEs)Events/100 years of patient exposure · Week 0 to Week 36 (inclusive) · number

Measure	Lira + Insulinn=127	Placebo + Insulinn=130
Adverse Events	449	350
Serious Adverse Events	8	5
Severe Adverse Events	5	1
Moderate Adverse Events	8	14
Mild Adverse Events	436	335

Number of Confirmed Hypoglycaemic EpisodesEpisodes/100 years of patient exposure · Week 0 to week 36 (inclusive) · number

Lira + Insulinn=127	Placebo + Insulinn=130
146	187

The trial

How NCT01572740 was run

This trial is conducted in Asia. The purpose of the trial is to investigate the efficacy and safety of liraglutide in combination with insulin therapy compared to insulin alone in Japanese subjects with type 2 diabetes mellitus. Subjects will remain on their pre-trial insulin therapy.

Lira+Insulin
Placebo+Insulin

Who could join the trial

Inclusion Criteria: * Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months * Current insulin therapy (basal insulin, premixed insulin or basal-bolus regimen) in addition to diet and exercise therapy for at least 12 weeks prior to trial start. Their therapy is stable and fluctuation of total daily insulin dose is within plus/minus 20% for at least 12 weeks prior to trial start and current total daily insulin dose equal to or greater than 10 (I)U/day * Glycosylated haemoglobin (HbA1c) between 7.5 and 11.0% (both inclusive) * Body Mass Index (BMI) below 45.0 kg/m\^2 Exclusion Criteria: * Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as, but not limited to systemic corticosteroids, beta-antagonists or monoamine oxidase (MAO) inhibitors * Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode during last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months * Known proliferative retinopathy or maculopathy requiring treatment according to the investigator * Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist within 12 weeks prior to screening * Treatment with any oral antidiabetic drugs (OADs) within 12 weeks prior to screening

Published papers

Papers from NCT01572740

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

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