Phase 3 · Liraglutide

NCT01272219 trial results

Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, Multinational Trial With Stratification of Subject to Either 56 or 160 Weeks of Treatment Based on Pre-diabetes Status at Randomisation

Change From Baseline in Fasting Body Weight (percent change), Week 0, Week 56. Liraglutide 3.0 mg (56-Week): -7.98; Liraglutide Placebo (56-Week): -2.62.

Participants: 3,731
Status: completed
Completed: 2015-03-02
Sponsor: Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT01272219), updated at source Jan 19, 2018. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT01272219 measured first

Change From Baseline in Fasting Body Weightpercent change · Week 0, Week 56 · mean

Liraglutide 3.0 mg (56-Week)n=2,432	Liraglutide Placebo (56-Week)n=1,220
-7.98(6.67)	-2.62(5.74)

Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight.percentage of subjects · At Week 56 · number

Liraglutide 3.0 mg (56-Week)n=2,432	Liraglutide Placebo (56-Week)n=1,220
63.2	27.1

Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weightpercentage of subjects · At 56 weeks · number

Liraglutide 3.0 mg (56-Week)n=2,432	Liraglutide Placebo (56-Week)n=1,220
33.1	10.6

Proportion of Subjects With Onset of Type 2 DiabetesSubject · At 160 weeks · number

Liraglutide 3.0 mg (160-Week)n=1,472	Liraglutide Placebo (160-Week)n=738
26	46

Side effects by arm

Side effects in NCT01272219

Percent of participants affected, For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).. The most common events the registry lists.

Event	Liraglutide 3.0 mg, Pre-diabetes	Liraglutide Placebo, Pre-diabetes	Liraglutide 3.0 mg, no Pre-diabetes	Liraglutide Placebo, no Pre-diabetes
Any serious event	15.1%	12.7%	6.2%	3.9%
Nausea	40.8%	17%	43.7%	16%
Nasopharyngitis	26.5%	27.8%	20.2%	22.6%
Diarrhoea	25.5%	14.2%	21%	9.4%
Constipation	21.9%	11.3%	21.2%	9%
Vomiting	19.7%	5.6%	18%	5.1%
Hypoglycaemia	19.4%	4.6%	18.4%	6%
Headache	17.9%	16.4%	13.3%	11.9%
Upper respiratory tract infection	15.5%	15.9%	10.6%	11.1%
Back pain	13%	15.6%	8%	8.4%
Arthralgia	12.2%	12.8%	4%	4.7%
Influenza	11.9%	10.6%	6.8%	5.3%
Decreased appetite	11.1%	3.6%	10.7%	3.3%
Dyspepsia	10.2%	4.6%	10.7%	2.9%
Fatigue	10.1%	7.7%	8.3%	5.5%
Dizziness	9.8%	7.3%	7%	3.9%
Lipase increased	9.5%	3.2%	3.7%	2.1%
Gastroenteritis	9.1%	6.1%	5%	4.9%
Sinusitis	8.5%	8.6%	8.8%	7.2%
Injection site haematoma	6%	8.1%	6.7%	8.6%
Bronchitis	7.5%	8.2%	3.7%	5.3%
Urinary tract infection	8.1%	5.7%	5%	3.1%
Cough	7.3%	7.9%	3.6%	4.5%
Abdominal pain	7.3%	4.9%	6.5%	3.9%
Abdominal pain upper	7.2%	5.3%	6.6%	3.7%
Pain in extremity	7.1%	7.2%	2.6%	4.5%

Secondary outcomes

What else it measured

Change From Baseline in Waist Circumference (cm)cm · Week 0, Week 56 · mean

Liraglutide 3.0 mg (56-Week)n=2,437	Liraglutide Placebo (56-Week)n=1,225
-8.19(7.31)	-3.94(6.58)

Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline)cm · Week 0, week 160 · mean

Liraglutide 3.0 mg (160-Week)n=1,472	Liraglutide Placebo (160-Week)n=738
-6.87(8.28)	-3.37(7.47)

Pre-diabetes Status After 56 Weeks of Treatmentpercentage of subjects · Week 0, Week 56 · number

Measure	Liraglutide 3.0 mg (56-Week)n=2,437	Liraglutide Placebo (56-Week)n=1,225
With No Pre-diabetes	78.3	50.9
With Pre-diabetes	20.6	46.1
With Transient Type 2 Diabetes	0.9	1.8
With Confirmed Type 2 Diabetes	0.2	1.1

Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatmentpercentage of subjects · Week 0, week 160 · number

Measure	Liraglutide 3.0 mg (160-Week)n=1,472	Liraglutide Placebo (160-Week)n=738
With No Pre-diabetes	65.9	36.3
With Pre-diabetes	31.3	54.9
With Transient Type 2 Diabetes	1.1	2.6
With Confirmed Type 2 Diabetes	1.8	6.2

Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline)percent change · Week 0, week 160 · mean

Liraglutide 3.0 mg (160-Week)n=1,467	Liraglutide Placebo (160-Week)n=734
-6.14(7.34)	-1.89(6.27)

Proportion of Subjects Losing at Least 5% and Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (Subjects With Pre-diabetes at Baseline)percentage of subjects · At 160 weeks · number

Measure	Liraglutide 3.0 mg (160-Week)n=1,467	Liraglutide Placebo (160-Week)n=734
Losing >=5% of baseline body weight	49.6	23.7
Losing >10% of baseline body weight	24.8	9.9

Change From Week 56 in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)percent change · Week 56, Week 68 · mean

Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)n=349	Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)n=346	Liraglutide Placebo, no Pre-diabetesn=299
0.69(2.58)	2.91(3.01)	0.28(2.39)

Change From Baseline in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)percent change · Week 0, Week 68 · mean

Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)n=349	Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)n=347	Liraglutide Placebo, no Pre-diabetesn=298
-8.44(7.23)	-6.77(7.67)	-3.11(7.52)

The trial

How NCT01272219 was run

This trial is conducted in Africa, Asia, Europe, Oceania, North America and South America. The aim of this clinical trial is to evaluate the potential of liraglutide to induce and maintain weight loss over 56 weeks in obese subjects or overweight subjects with co-morbidities. Furthermore, the aim is to investigate the long term potential of liraglutide to delay the onset of type 2 diabetes in subjects diagnosed with pre-diabetes at baseline. Based on body mass index (BMI) and pre-diabetes status, subjects will be randomised to either 68 weeks (56 weeks of randomised treatment followed by a 12 week re-randomised treatment period) or 160 weeks of treatment (160 week treatment will only be applicable to subjects with pre-diabetes status at baseline).

Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)
Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)
Liraglutide Placebo, no Pre-diabetes
Liraglutide 3.0mg, Pre-diabetes
Liraglutide Placebo, Pre-diabetes

Who could join the trial

Inclusion Criteria: * Informed consent obtained * Body Mass Index (BMI) of 30.0 kg/m\^2 or above * Body Mass Index (BMI) of 27 kg/m\^2 or above in the presence of co-morbidities of treated or untreated dyslipidemia and/or hypertension * Stable body weight * Preceding failed dietary effort Exclusion Criteria: * Known type 1 or type 2 diabetes * Glycosylated haemoglobin (HbA1c) of 6.5 % or above (Screening visit 1) or FPG of 126 mg/dL (7 mmol/L) or above (Screening visit 2) or 2 hour post-challenge (OGTT) plasma glucose of 200 mg/dL (11.1 mmol/L) or above (Screening visit 2) * Screening calcitonin of 50 ng/L or above * Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC) * Personal history of non-familial medullary thyroid carcinoma * History of acute or chronic pancreatitis * Obesity induced by drug treatment * Use of approved weight lowering pharmacotherapy * Previous surgical treatment of obesity * History of major depressive disorder or suicide attempt * Uncontrolled hypertension (systolic blood pressure of 160 mmHg or above and/or diastolic blood pressure of 100 mmHg or above)

Published papers

Papers from NCT01272219

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

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.