Phase 3 · Liraglutide

LEAD-3 trial results

Liraglutide Effect and Action in Diabetes (LEAD-3): Effect on Glycemic Control of Liraglutide Versus Glimepiride in Type 2 Diabetes

Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (percentage point of total HbA1c), week 0, week 52. Lira 1.8: -1.14; Lira 1.2: -0.84; Glimepiride: -0.51.

Participants
746
Status
terminated
Completed
2008-11
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT00294723), updated at source Mar 7, 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-3 measured first

Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52percentage point of total HbA1c · week 0, week 52 · least squares mean
Lira 1.8n=234Lira 1.2n=236Glimepiriden=241
-1.14(0.08)-0.84(0.08)-0.51(0.08)
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104percentage point of total HbA1c · week 0, week 104 · least squares mean
Lira 1.8n=234Lira 1.2n=236Glimepiriden=241
-0.88(0.09)-0.59(0.09)-0.28(0.09)
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156percentage point of total HbA1c · week 0, week 156 · least squares mean
Lira 1.8n=234Lira 1.2n=236Glimepiriden=241
-0.71(0.09)-0.44(0.09)-0.16(0.08)
Side effects by arm

Side effects in LEAD-3

Percent of participants affected, The adverse events were collected in a time span of 195 weeks.. The most common events the registry lists.

EventLira 1.8 (Weeks 0-104)Lira 1.2 (Weeks 0-104)Glimepiride (Weeks 0-104)Lira 1.8 (Weeks 104-195)Lira 1.2 (Weeks 104-195)Glimepiride (Weeks 104-195)
Any serious event8.9%9.2%8.1%8.1%1.9%7.1%
Nausea30.5%28.7%8.5%0%0%0%
Diarrhoea19.5%17.5%9.3%8.1%5.7%3.6%
Upper respiratory tract infection13%14.3%8.9%12.9%15.1%3.6%
Vomiting10.2%13.1%4%0%0%0%
Constipation11.8%8.4%4.8%0%0%0%
Hypertension4.5%5.6%6.9%3.2%11.3%7.1%
Headache7.3%11.2%9.3%1.6%3.8%10.7%
Influenza11%9.2%8.5%4.8%9.4%7.1%
Urinary tract infection5.7%10.4%5.2%9.7%7.5%0%
Nasopharyngitis6.5%9.2%7.3%0%0%0%
Sinusitis7.3%8.4%7.3%6.5%1.9%0%
Dizziness7.7%5.2%5.2%0%0%0%
Back pain6.9%7.2%6.9%4.8%7.5%3.6%
Gastritis0%0%0%4.8%3.8%7.1%
Bronchitis3.7%6%4.4%6.5%3.8%0%
Pharyngitis0%0%0%6.5%3.8%3.6%
Pain in extremity6.1%3.6%3.2%1.6%5.7%0%
Arthralgia2.4%4.4%6%0%0%0%
Cough5.7%2%4.4%3.2%5.7%0%
Depression5.7%3.2%2%0%0%0%
Flatulence5.3%1.6%2%0%0%0%
Fatigue5.3%3.2%3.6%0%0%0%
Secondary outcomes

What else it measured

Change in Body Weight at Week 52kg · week 0, week 52 · least squares mean
Lira 1.8n=240Lira 1.2n=245Glimepiriden=248
-2.45(0.28)-2.05(0.28)1.12(0.27)
Change in Body Weight at Week 104kg · week 0, week 104 · least squares mean
Lira 1.8n=240Lira 1.2n=245Glimepiriden=248
-2.70(0.32)-1.89(0.31)0.95(0.30)
Change in Body Weight at Week 156kg · week 0, week 156 · least squares mean
Lira 1.8n=240Lira 1.2n=245Glimepiriden=248
-2.43(0.32)-1.68(0.32)1.05(0.31)
Change in Fasting Plasma Glucose at Week 52mg/dL · week 0, week 52 · least squares mean
Lira 1.8n=230Lira 1.2n=234Glimepiriden=242
-25.57(3.50)-15.21(3.50)-5.29(3.33)
Change in Fasting Plasma Glucose at Week 104mg/dL · week 0, week 104 · least squares mean
Lira 1.8n=230Lira 1.2n=234Glimepiriden=242
-15.82(3.85)-9.36(3.85)1.97(3.66)
Change in Fasting Plasma Glucose at Week 156mg/dL · week 0, week 156 · least squares mean
Lira 1.8n=230Lira 1.2n=234Glimepiriden=242
-12.06(3.8)-5.45(3.8)4.57(3.62)
Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52mg/dL · week 0, week 52 · least squares mean
Lira 1.8n=191Lira 1.2n=187Glimepiriden=182
-37.4(3.37)-30.8(3.40)-24.5(3.32)
Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104mg/dL · week 0, week 104 · least squares mean
Lira 1.8n=191Lira 1.2n=187Glimepiriden=183
-37.15(3.64)-27.34(3.68)-24.85(3.58)
Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156mg/dL · week 0, week 156 · least squares mean
Lira 1.8n=191Lira 1.2n=187Glimepiriden=183
-34.83(3.65)-25.68(3.69)-23.84(3.59)
Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52mg/dL · week 0, week 52 · least squares mean
Lira 1.8n=191Lira 1.2n=187Glimepiriden=182
-9.6(2.07)-8.4(2.10)-5.6(2.04)
Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104mg/dL · week 0, week 104 · least squares mean
Lira 1.8n=191Lira 1.2n=187Glimepiriden=183
-11.76(2.11)-8.28(2.14)-7.95(2.08)
Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156mg/dL · week 0, week 156 · least squares mean
Lira 1.8n=191Lira 1.2n=187Glimepiriden=183
-11.01(2.11)-7.53(2.14)-7.97(2.07)
The trial

How LEAD-3 was run

This trial is conducted in North America (the United States of America (USA) and Mexico). The trial is designed to evaluate the effects of treatment with liraglutide versus glimepiride in subjects with type 2 diabetes. The trial is a 52-week randomised, double-blind trial period plus a 52-week open-label extension (week 104) followed by an additional 156-week continued open-label extension. The total duration of the treatment period is planned to be 260 weeks (5 years).

  • Lira 1.8: Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195).
  • Lira 1.2: Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195).
  • Glimepiride - 1: Glimepiride 8 mg once daily + liraglutide placebo 200 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195).
  • Glimepiride - 2: Glimepiride 8 mg once daily + liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195).
Who could join the trial

Inclusion Criteria: * Type 2 diabetes * TTreatment with diet/exercise or with not more than half maximal dose of oral anti-diabetic drugs alone for at least 2 months * Diet/exercise treated subjects with HbA1c between 7.0% and 11%, inclusive * OAD (oral anti-diabetic drug) treated subjects with HbA1c between 7.0% and 10%, inclusive * Body Mass Index (BMI) less than or equal to 45 kg/m\^2 Exclusion Criteria: * Treatment with insulin for the last 3 months, except short-term treatment for intercurrent illness * Treatment with any drug that could interfere with the glucose level (besides use of a single anti-diabetic compound) * Any serious medical condition

Published papers

Papers from LEAD-3

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

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