Phase 3 · Liraglutide

NCT01617434 trial results

The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes

Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26 (percentage of glycosylated haemoglobin), Week 0 to Week 26. Liraglutide: -1.30; Placebo: -0.11.

Participants: 451
Status: completed
Completed: 2013-10
Sponsor: Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT01617434), updated at source Mar 8, 2017. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT01617434 measured first

Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26percentage of glycosylated haemoglobin · Week 0 to Week 26 · mean

Liraglutiden=215	Placebon=217
-1.30(1.015)	-0.11(1.088)

Side effects by arm

Side effects in NCT01617434

Percent of participants affected, Week 0 to Week 26 + 7 days follow up. The most common events the registry lists.

Event	Liraglutide	Placebo
Any serious event	4.9%	3.1%
Nausea	22.2%	3.1%
Diarrhoea	10.7%	4.9%
Decreased appetite	9.8%	2.2%
Vomiting	8.9%	0.9%
Dyspepsia	7.1%	0.9%
Influenza	3.6%	7.1%
Lipase increased	7.1%	2.2%
Headache	3.6%	7.1%
Nasopharyngitis	5.8%	6.2%
Back pain	5.3%	5.3%

Secondary outcomes

What else it measured

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

Liraglutiden=213	Placebon=217
-1.44(2.494)	-0.16(3.006)

Change in Mean Self-Measured Plasma Glucose (SMPG) of 7-Point Profile From Baseline to Week 26mmol/L · Week 0 to Week 26 · mean

Liraglutiden=191	Placebon=196
-2.61(2.248)	-1.02(3.061)

Change in Body Weight From Baseline to Week 26kg · Week 0 to Week 26 · mean

Liraglutiden=215	Placebon=216
-3.54(3.669)	-0.42(3.909)

Number of Subjects Achieving HbA1c Below 7.0% (American Diabetes Association [ADA] Target)percentage of subjects · At Week 26 · number

Liraglutiden=211	Placebon=217
59.24	14.02

Number of Subjects Achieving HbA1c Below or Equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target)percentage of subjects · At Week 26 · number

Liraglutiden=211	Placebon=217
42.91	3.60

Number of Adverse Events (AEs) During The Randomised Treatment PeriodEvents/1000 years of patient exposure · Week 0 to Week 26 + 7 days follow up · number

Measure	Liraglutiden=225	Placebon=225
Adverse Events	4918	3737
Serious Adverse Events	149	101
Severe Adverse Events	169	101
Moderate Adverse Events	1274	1060
Mild Adverse Events	3474	2575

Number of Minor Hypoglycaemic Episodes During The Randomised Treatment PeriodEvents/100 years of patient exposure · Week 0 to Week 26 + 7 days follow up · number

Liraglutiden=225	Placebon=225
126	83

Number of Severe Hypoglycaemic Episodes During The Randomised Treatment PeriodEvents/100 years of patient exposure · Week 0 to Week 26 + 7 days follow up · number

Liraglutiden=225	Placebon=225
0	0

The trial

How NCT01617434 was run

This trial is conducted in Asia, Europe and North and South America. The aim of the trial is to investigate the effect of liraglutide versus placebo when added to basal insulin analogues with or without metformin in subjects with type 2 diabetes.

Liraglutide
Placebo

Who could join the trial

Inclusion Criteria: * Diagnosed with type 2 diabetes for at least 180 days prior to screening and treated with stable basal insulin analogue dose of minimum 20 U/day with or without stable metformin equal to or above 1500 mg/day for at least 8 weeks prior to screening (defined as insulin adjustments less than 10% during the past 8 weeks as assessed by the investigator) * HbA1c (glycosylated haemoglobin A1c) 7.0-10.0% (both inclusive) * Body mass index (BMI) 20-45 kg/m\^2 (both inclusive) Exclusion Criteria: * Female of child-bearing potential who is pregnant, breast-feeding or intending to become pregnant * Recurrent severe hypoglycaemic episodes or hypoglycaemic unawareness * Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to screening * Impaired liver or renal function * Uncontrolled treated or untreated hypertension (systolic blood pressure (SBP) equal to or above 180 mmHg and/or diastolic blood pressure (DBP) equal to or above 100 mmHg) * Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator's opinion could interfere with results of the trial * Known or suspected abuse of alcohol or narcotics

Published papers

Papers from NCT01617434

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

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