Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
| Group | Value (percentage of hemoglobin) | Spread |
|---|---|---|
| Lixisenatide | -0.79 | 0.053 |
| Exenatide | -0.96 | 0.054 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataShort name GETGOAL-X
United States, Argentina, Austria, Brazil, Colombia, Denmark, Finland, Germany, Greece, Hungary, Italy, Netherlands, Norway, Poland, Puerto Rico, Russia, Spain, Sweden
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to compare the benefits and risks of lixisenatide (AVE0010) in comparison to exenatide (Byetta®), as an add-on treatment to metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide in comparison to exenatide (Byetta®), as an add-on treatment to metformin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effects of lixisenatide on percentage of patients reaching HbA1c less than 7 percent (%) or HbA1c less than or equal to (\<=) 6.5%, fasting plasma glucose (FPG), body weight; to evaluate safety, tolerability and to assess the impact of gastrointestinal tolerance on quality of life (QoL) (patient assessment of upper gastrointestinal disorders - quality of life \[PAGI-QOL\]).
Experimental
Lixisenatide
2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
Active comparator
Exenatide
1-step initiation regimen of exenatide: 5 mcg twice daily (BID) for 4 weeks, followed by 10 mcg BID up to the end of treatment.
Outcomes the sponsor listed as primary.
Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
Time frame · Baseline, Week 24
Absolute Change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Time frame · Baseline, Week 24
Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
Change From Baseline in Body Weight at Week 24
Time frame · Baseline, Week 24
Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24
Time frame · Week 24
The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24
Time frame · Week 24
The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period
Time frame · Baseline up to Week 24
Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG \>270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG \>240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG \>200 mg/dL (11.1 mmol/L) or HbA1c \> 8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of hemoglobin) | Spread |
|---|---|---|
| Lixisenatide | -0.79 | 0.053 |
| Exenatide | -0.96 | 0.054 |
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Lixisenatide | -1.22 | 0.116 |
| Exenatide | -1.45 | 0.119 |
| Group | Value (kilogram) | Spread |
|---|---|---|
| Lixisenatide | -2.96 | 0.231 |
| Exenatide | -3.98 | 0.232 |
| Group | Value (percentage of participants) |
|---|---|
| Lixisenatide | 48.5 |
| Exenatide | 49.8 |
| Group | Value (percentage of participants) |
|---|---|
| Lixisenatide | 28.5 |
| Exenatide | 35.4 |
| Group | Value (percentage of participants) |
|---|---|
| Lixisenatide | 2.2 |
| Exenatide | 3.8 |
| Group | Value (percentage of participants) |
|---|---|
| Lixisenatide | 25.1 |
| Exenatide | 31.4 |
| Group | Value (participants) |
|---|---|
| Lixisenatide | 16 |
| Exenatide | 46 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Lixisenatide2-step initiation regimen of lixisenatide. | – | 26 / 318 | 204 / 318 |
| Exenatide1-step initiation regimen of exenatide. | – | 22 / 316 | 218 / 316 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
2 studies on this page
Indexing hint: Meta-analysis (pooled) · 2025
Natale et al. 2025The Cochrane database of systematic reviewscited by 8
PMID 39963952PMC11834151DOI 10.1002/14651858.cd015849.pub2PUB-39963952
Indexing hint: Randomized controlled trial · 2013
Rosenstock et al. 2013Diabetes carecited by 200
PMID 23698396PMC3781502DOI 10.2337/dc12-2709PUB-23698396
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