Phase 3 · Liraglutide

LEAD-6 trial results

Effect of Liraglutide or Exenatide Added to a Background Treatment of Metformin, Sulphonylurea or a Combination of Both on Glycaemic Control in Subjects With Type 2 Diabetes

Change in Glycosylated A1c (HbA1c) at Week 26 (percentage point of total HbA1c), week 0, week 26. Liraglutide -> Liraglutide -> Liraglutide: -1.12; Exenatide -> Liraglutide -> Liraglutide: -0.79.

Participants: 467
Status: completed
Completed: 2009-04
Sponsor: Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT00518882), 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 LEAD-6 measured first

Change in Glycosylated A1c (HbA1c) at Week 26percentage point of total HbA1c · week 0, week 26 · least squares mean

Liraglutide -> Liraglutide -> Liraglutiden=227	Exenatide -> Liraglutide -> Liraglutiden=226
-1.12(0.08)	-0.79(0.08)

Side effects by arm

Side effects in LEAD-6

Percent of participants affected, The adverse events were collected in a time span of 78 weeks.. The most common events the registry lists.

Event	Liraglutide -> Liraglutide -> Liraglutide	Exenatide -> Liraglutide -> Liraglutide
Any serious event	9.8%	9.9%
Nausea	27.2%	29.3%
Nasopharyngitis	18.3%	18.1%
Diarrhoea	14.9%	15.9%
Headache	12.3%	12.1%
Upper respiratory tract infection	11.1%	12.1%
Vomiting	8.1%	11.2%
Dyspepsia	10.6%	6%
Back pain	9.4%	5.2%
Bronchitis	6.4%	8.6%
Constipation	7.7%	4.3%
Dizziness	6%	3.9%
Influenza	5.5%	4.7%
Anorexia	4.3%	5.2%
Hypertension	4.3%	5.2%
Sinusitis	5.1%	3.9%

Secondary outcomes

What else it measured

Change in Glycosylated A1c (HbA1c), Weeks 26-78percentage point of total HbA1c · week 26, week 78 · mean

Liraglutide -> Liraglutide -> Liraglutiden=198	Exenatide -> Liraglutide -> Liraglutiden=183
0.25(0.803)	-0.00(0.924)

Change in Glycosylated A1c (HbA1c) at Week 78percentage point of total HbA1c · week 0, week 78 · mean

Liraglutide -> Liraglutide -> Liraglutiden=198	Exenatide -> Liraglutide -> Liraglutiden=183
-0.98(1.119)	-0.85(1.105)

Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26percentage (%) of subjects · week 0, week 26 · number

Measure	Liraglutide -> Liraglutide -> Liraglutiden=233	Exenatide -> Liraglutide -> Liraglutiden=231
Treatment target HbA1c < 7%	53	42
Treatment target HbA1c =< 6.5%	34	20

Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78percentage (%) of subjects · week 0, week 78 · number

Measure	Liraglutide -> Liraglutide -> Liraglutiden=200	Exenatide -> Liraglutide -> Liraglutiden=186
Treatment target HbA1c < 7%	47	48
Treatment target HbA1c =< 6.5%	31	35

Change in Body Weight at Week 26kg · week 0, week 26 · least squares mean

Liraglutide -> Liraglutide -> Liraglutiden=231	Exenatide -> Liraglutide -> Liraglutiden=229
-3.24(0.33)	-2.87(0.33)

Change in Body Weight, Weeks 26-78kg · week 26, week 78 · mean

Liraglutide -> Liraglutide -> Liraglutiden=199	Exenatide -> Liraglutide -> Liraglutiden=184
-0.4(3.24)	-0.7(3.67)

Change in Body Weight at Week 78kg · week 0, week 78 · mean

Liraglutide -> Liraglutide -> Liraglutiden=199	Exenatide -> Liraglutide -> Liraglutiden=184
-3.3(4.63)	-3.2(4.44)

Change in Fasting Plasma Glucose at Week 26mmol/L · week 0, week 26 · least squares mean

Liraglutide -> Liraglutide -> Liraglutiden=225	Exenatide -> Liraglutide -> Liraglutiden=219
-1.61(0.20)	-0.60(0.20)

Change in Fasting Plasma Glucose, Weeks 26-78mmol/L · week 26, week 78 · mean

Liraglutide -> Liraglutide -> Liraglutiden=197	Exenatide -> Liraglutide -> Liraglutiden=182
0.7(1.84)	-0.1(2.42)

Change in Fasting Plasma Glucose at Week 78mmol/L · week 0, week 78 · mean

Liraglutide -> Liraglutide -> Liraglutiden=197	Exenatide -> Liraglutide -> Liraglutiden=182
-1.3(2.50)	-0.8(2.76)

Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26mmol/L · week 0, week 26 · least squares mean

Liraglutide -> Liraglutide -> Liraglutiden=207	Exenatide -> Liraglutide -> Liraglutiden=196
-0.83(0.28)	-2.16(0.28)

Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26mmol/L · week 0, week 26 · least squares mean

Liraglutide -> Liraglutide -> Liraglutiden=207	Exenatide -> Liraglutide -> Liraglutiden=196
0.06(0.28)	0.06(0.28)

The trial

How LEAD-6 was run

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea or a combination of both in subjects with type 2 diabetes. Two trial periods: A 26 week randomised, followed by a 52 week extension (14 + 38 weeks) where all subjects received liraglutide + OAD after previous randomisation to either liraglutide or exenatide, both combined with OAD treatment.

Liraglutide: Liraglutide 1.8 mg once daily + subject's own OAD treatment
Exenatide: Exenatide 10 mcg twice daily + subject's own OAD treatment

Who could join the trial

Inclusion Criteria: * Type 2 diabetes * Stable treatment with Oral Anti-Diabetic Drugs (metformin, sulphonylurea or a combination of both) for at least 3 months at the discretion of the Investigator * HbA1C equal to or greater than 7.0% and equal to or lower than 11.0% * Body Mass Index (BMI) equal to or lower than 45.0 kg/m2 Exclusion Criteria: * Previous treatment with insulin * Treatment with any anti-diabetic drug other than metformin and sulphonylurea * Any previous exposure to exenatide or liraglutide * Impaired liver or/and renal function * History of any significant cardiac events * Known retinopathy or maculopathy requiring acute treatment * Recurrent major hypoglycaemia or hypoglycaemic unawareness

Published papers

Papers from LEAD-6

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

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