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Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes
Effect of Liraglutide or Glimepiride Added to Metformin on Glycaemic Control in Subjects With Type 2 Diabetes
Lead sponsor
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
50
Recruiting sites
—
Enrollment
929
actual
Study population
Type 2 diabetes
Key I/E criteria
•BMI ≤45•HbA1c 7-11%
Primary endpoint
•HbA1c, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Exclusion criteria
Endpoints (16)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
2 endpointsChange in Body Weight
Time frame:week 0, week 16
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (mean), kg | 95% CI |
|---|---|---|
| Lira 0.6 + Met | -1.8 | — |
| Lira 1.2 + Met | -2.3 | — |
| Lira 1.8 + Met | -2.4 | — |
| Glim + Met | 0.1 | — |
Change in Body Weight
Time frame:week 0, week 16
Body weight, absolute change (kg)
change from baseline, improvement
Glycemic / diabetes
8 endpointsChange in Glycosylated Haemoglobin A1c (HbA1c)
Time frame:week 0, week 16
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), percentage point of total HbA1c | 95% CI |
|---|---|---|
| Lira 0.6 + Met | -1.0 | — |
| Lira 1.2 + Met | -1.3 | — |
| Lira 1.8 + Met | -1.4 | — |
| Glim + Met | -1.3 | — |
Change in Glycosylated Haemoglobin A1c (HbA1c)
Time frame:week 0, week 16
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in Self-measured Fasting Plasma Glucose
Time frame:week 0, week 16
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (mean), mg/dL | 95% CI |
|---|---|---|
| Lira 0.6 + Met | -1.83 | — |
| Lira 1.2 + Met | -1.96 | — |
| Lira 1.8 + Met | -2.28 | — |
| Glim + Met | -2.13 | — |
7-point Self-measured Plasma Glucose Profiles
Time frame:week 0, 8, 12 and 16
Postprandial glucose
descriptive, improvement
Posted result
| Group | Value (mean), mg/dl | 95% CI |
|---|---|---|
| Lira 0.6 + MetWeek 0 - Before breakfast | 168.2 | — |
| Week 0 - 90 minutes after breakfast | 245.9 | — |
| Week 0 - Before lunch | 178.5 | — |
| Week 0 - 90 minutes after lunch | 234.2 | — |
| Week 0 - Before dinner | 194.8 | — |
| Week 0 - 90 minutes after dinner | 239.6 | — |
| Week 0 - Bedtime | 205.7 | — |
| Week 8 - Before breakfast | 137.0 | — |
| Week 8 - 90 minutes after breakfast | 198.5 | — |
| Week 8 - Before lunch | 144.8 | — |
| Week 8 - 90 minutes after lunch | 187.2 | — |
| Week 8 - Before dinner | 159.1 | — |
| Week 8 - 90 minutes after dinner | 193.7 | — |
| Week 8 - Bedtime | 169.1 | — |
| Week 12 - Before breakfast | 137.8 | — |
| Week 12 - 90 minutes after breakfast | 197.5 | — |
| Week 12 - Before lunch | 141.8 | — |
| Week 12 - 90 minutes after lunch | 183.7 | — |
| Week 12 - Before dinner | 156.4 | — |
| Week 12 - 90 minutes after dinner | 197.2 | — |
| Week 12 - Bedtime | 168.2 | — |
| Week 16 - Before breakfast | 137.3 | — |
| Week 16 - 90 minutes after breakfast | 195.6 | — |
| Week 16 - Before lunch | 140.5 | — |
| Week 16 - 90 minutes after lunch | 185.8 | — |
| Week 16 - Before dinner | 151.5 | — |
| Week 16 - 90 minutes after dinner | 195.0 | — |
| Week 16 - Bedtime | 166.4 | — |
| Lira 1.2 + MetWeek 0 - Before breakfast | 167.5 | — |
| Week 0 - 90 minutes after breakfast | 248.0 | — |
| Week 0 - Before lunch | 180.5 | — |
| Week 0 - 90 minutes after lunch | 232.3 | — |
| Week 0 - Before dinner | 184.8 | — |
| Week 0 - 90 minutes after dinner | 239.6 | — |
| Week 0 - Bedtime | 208.1 | — |
| Week 8 - Before breakfast | 130.4 | — |
| Week 8 - 90 minutes after breakfast | 190.1 | — |
| Week 8 - Before lunch | 136.5 | — |
| Week 8 - 90 minutes after lunch | 176.9 | — |
| Week 8 - Before dinner | 147.8 | — |
| Week 8 - 90 minutes after dinner | 187.1 | — |
| Week 8 - Bedtime | 161.6 | — |
| Week 12 - Before breakfast | 130.2 | — |
| Week 12 - 90 minutes after breakfast | 185.7 | — |
| Week 12 - Before lunch | 135.6 | — |
| Week 12 - 90 minutes after lunch | 174.7 | — |
| Week 12 - Before dinner | 143.4 | — |
| Week 12 - 90 minutes after dinner | 185.7 | — |
| Week 12 - Bedtime | 158.9 | — |
| Week 16 - Before breakfast | 132.9 | — |
| Week 16 - 90 minutes after breakfast | 188.7 | — |
| Week 16 - Before lunch | 137.0 | — |
| Week 16 - 90 minutes after lunch | 181.4 | — |
| Week 16 - Before dinner | 148.4 | — |
| Week 16 - 90 minutes after dinner | 183.3 | — |
| Week 16 - Bedtime | 159.8 | — |
| Lira 1.8 + MetWeek 0 - Before breakfast | 168.8 | — |
| Week 0 - 90 minutes after breakfast | 245.4 | — |
| Week 0 - Before lunch | 176.9 | — |
| Week 0 - 90 minutes after lunch | 234.4 | — |
| Week 0 - Before dinner | 190.9 | — |
| Week 0 - 90 minutes after dinner | 244.0 | — |
| Week 0 - Bedtime | 219.3 | — |
| Week 8 - Before breakfast | 133.7 | — |
| Week 8 - 90 minutes after breakfast | 178.5 | — |
| Week 8 - Before lunch | 138.0 | — |
| Week 8 - 90 minutes after lunch | 177.9 | — |
| Week 8 - Before dinner | 144.2 | — |
| Week 8 - 90 minutes after dinner | 183.3 | — |
| Week 8 - Bedtime | 155.8 | — |
| Week 12 - Before breakfast | 130.2 | — |
| Week 12 - 90 minutes after breakfast | 178.6 | — |
| Week 12 - Before lunch | 134.1 | — |
| Week 12 - 90 minutes after lunch | 173.7 | — |
| Week 12 - Before dinner | 144.5 | — |
| Week 12 - 90 minutes after dinner | 183.5 | — |
| Week 12 - Bedtime | 158.9 | — |
| Week 16 - Before breakfast | 128.6 | — |
| Week 16 - 90 minutes after breakfast | 177.6 | — |
| Week 16 - Before lunch | 137.8 | — |
| Week 16 - 90 minutes after lunch | 173.2 | — |
| Week 16 - Before dinner | 140.9 | — |
| Week 16 - 90 minutes after dinner | 173.2 | — |
| Week 16 - Bedtime | 151.6 | — |
| Glim + MetWeek 0 - Before breakfast | 163.8 | — |
| Week 0 - 90 minutes after breakfast | 238.5 | — |
| Week 0 - Before lunch | 175.8 | — |
| Week 0 - 90 minutes after lunch | 227.6 | — |
| Week 0 - Before dinner | 180.2 | — |
| Week 0 - 90 minutes after dinner | 231.6 | — |
| Week 0 - Bedtime | 202.7 | — |
| Week 8 - Before breakfast | 130.1 | — |
| Week 8 - 90 minutes after breakfast | 201.2 | — |
| Week 8 - Before lunch | 132.6 | — |
| Week 8 - 90 minutes after lunch | 184.3 | — |
| Week 8 - Before dinner | 143.3 | — |
| Week 8 - 90 minutes after dinner | 190.2 | — |
| Week 8 - Bedtime | 163.6 | — |
| Week 12 - Before breakfast | 128.5 | — |
| Week 12 - 90 minutes after breakfast | 200.8 | — |
| Week 12 - Before lunch | 129.3 | — |
| Week 12 - 90 minutes after lunch | 185.3 | — |
| Week 12 - Before dinner | 144.2 | — |
| Week 12 - 90 minutes after dinner | 188.5 | — |
| Week 12 - Bedtime | 159.9 | — |
| Week 16 - Before breakfast | 131.0 | — |
| Week 16 - 90 minutes after breakfast | 195.1 | — |
| Week 16 - Before lunch | 128.8 | — |
| Week 16 - 90 minutes after lunch | 182.2 | — |
| Week 16 - Before dinner | 144.9 | — |
| Week 16 - 90 minutes after dinner | 192.6 | — |
| Week 16 - Bedtime | 157.7 | — |
Change in Beta-cell Function
Time frame:week 0, week 16
change from baseline, improvement
Posted result
| Group | Value (mean), percentage point (%point) | 95% CI |
|---|---|---|
| Lira 0.6 + Met | 15.3 | — |
| Lira 1.2 + Met | 17.8 | — |
| Lira 1.8 + Met | 21.7 | — |
| Glim + Met | 21.8 | — |
Change in Self-measured Fasting Plasma Glucose
Time frame:week 0, week 16
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
7-point Self-measured Plasma Glucose Profiles
Time frame:week 0, 8, 12 and 16
Postprandial glucose
descriptive, improvement
Change in Beta-cell Function
Time frame:week 0, week 16
change from baseline, improvement
Cardiometabolic biomarkers
4 endpointsChange in Fasting Lipid Profile
Time frame:week 0, week 16
change from baseline, improvement
componentsTotal cholesterol, change, LDL-C, change, VLDL, change, HDL-C, change, Triglycerides, change, Free fatty acids, change
Posted result
| Group | Value (mean), mmol/L | 95% CI |
|---|---|---|
| Lira 0.6 + MetChange in TC (Absolute), N=221, 216, 216, 228 | 0.06 | — |
| Change in LDL-C (Absolute), N=221, 216, 216, 228 | 0.06 | — |
| Change in VLDL-C (Absolute), N=213, 210, 207, 220 | 0.03 | — |
| Change in HDL-C (Absolute), N=217, 212, 212, 220 | -0.02 | — |
| Change in TG (Absolute), N=220, 212, 213, 226 | -0.08 | — |
| Change in FFA (Absolute), N=218, 214, 216, 227 | -0.03 | — |
| Lira 1.2 + MetChange in TC (Absolute), N=221, 216, 216, 228 | -0.01 | — |
| Change in LDL-C (Absolute), N=221, 216, 216, 228 | -0.03 | — |
| Change in VLDL-C (Absolute), N=213, 210, 207, 220 | 0.05 | — |
| Change in HDL-C (Absolute), N=217, 212, 212, 220 | -0.05 | — |
| Change in TG (Absolute), N=220, 212, 213, 226 | -0.06 | — |
| Change in FFA (Absolute), N=218, 214, 216, 227 | -0.04 | — |
| Lira 1.8 + MetChange in TC (Absolute), N=221, 216, 216, 228 | -0.03 | — |
| Change in LDL-C (Absolute), N=221, 216, 216, 228 | 0.00 | — |
| Change in VLDL-C (Absolute), N=213, 210, 207, 220 | 0.01 | — |
| Change in HDL-C (Absolute), N=217, 212, 212, 220 | -0.05 | — |
| Change in TG (Absolute), N=220, 212, 213, 226 | -0.22 | — |
| Change in FFA (Absolute), N=218, 214, 216, 227 | -0.10 | — |
| Glim + MetChange in TC (Absolute), N=221, 216, 216, 228 | 0.02 | — |
| Change in LDL-C (Absolute), N=221, 216, 216, 228 | 0.04 | — |
| Change in VLDL-C (Absolute), N=213, 210, 207, 220 | 0.05 | — |
| Change in HDL-C (Absolute), N=217, 212, 212, 220 | -0.01 | — |
| Change in TG (Absolute), N=220, 212, 213, 226 | -0.07 | — |
| Change in FFA (Absolute), N=218, 214, 216, 227 | -0.02 | — |
Change in Fasting Lipid Profile, APO-B
Time frame:week 0, week 16
ApoB, change
change from baseline, improvement
Posted result
| Group | Value (median), g/L | 95% CI |
|---|---|---|
| Lira 0.6 + Met | 0.02 | — |
| Lira 1.2 + Met | 0.00 | — |
| Lira 1.8 + Met | -0.00 | — |
| Glim + Met | 0.01 | — |
Change in Fasting Lipid Profile
Time frame:week 0, week 16
change from baseline, improvement
componentsTotal cholesterol, change, LDL-C, change, VLDL, change, HDL-C, change, Triglycerides, change, Free fatty acids, change
Change in Fasting Lipid Profile, APO-B
Time frame:week 0, week 16
ApoB, change
change from baseline, improvement
Safety / tolerability / PK
2 endpointsHypoglycaemic Episodes
Time frame:weeks 0-16
Documented hypoglycemia
event count, event
Posted result
| Group | Value (number), episodes | 95% CI |
|---|---|---|
| Lira 0.6 + MetMajor | 0 | — |
| Minor | 6 | — |
| Symptoms only | 12 | — |
| Lira 1.2 + MetMajor | 0 | — |
| Minor | 0 | — |
| Symptoms only | 11 | — |
| Lira 1.8 + MetMajor | 0 | — |
| Minor | 5 | — |
| Symptoms only | 9 | — |
| Glim + MetMajor | 2 | — |
| Minor | 80 | — |
| Symptoms only | 86 | — |
Hypoglycaemic Episodes
Time frame:weeks 0-16
Documented hypoglycemia
event count, event
Publications (5)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Diabetes research and clinical practice2015 Apr (month)PMID25684604doi:10.1016/j.diabres.2015.01.001via CT.gov reference
- Diabetes research and clinical practice2012 Nov (month)PMID23010561doi:10.1016/j.diabres.2012.09.008via CT.gov reference
- The Journal of clinical endocrinology and metabolism2011 Jun (month)PMID21450987doi:10.1210/jc.2010-2822via clinicaltrials gov reference derived + pubmed nct search
- Diabetes, obesity & metabolism2011 Jan (month)PMID21114607doi:10.1111/j.1463-1326.2010.01323.xvia CT.gov reference
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.