Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
| Group | Value (percentage of hemoglobin) | Spread |
|---|---|---|
| Placebo (Combined) | -0.42 | 0.099 |
| Lixisenatide (Two-Step Titration) | -0.83 | 0.099 |
| Lixisenatide (One-Step Titration) | -0.92 | 0.101 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataShort name GETGOAL-F1
United States, Brazil, Chile, Colombia, Estonia, Germany, Italy, Lithuania, Malaysia, Mexico, Philippines, Poland, Romania, Slovakia, Ukraine
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 evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, 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 when added to metformin on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction when it is used in two steps dose titration regimen at Week 24. Secondary objectives are to assess the effects of lixisenatide when added to metformin on glycemic control in comparison to placebo in terms of HbA1c reduction when it is used in a one-step dose titration regimen, the percentage of patients with HbA1c less than 7 percent or less than or equal to 6.5%, body weight, fasting plasma glucose (FPG); to assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.
Experimental
Lixisenatide (Two-Step Titration)
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.
Experimental
Lixisenatide (One-Step Titration)
1-step initiation regimen of lixisenatide: 10 mcg QD for 2 weeks, then 20 mcg QD up to the end of treatment.
Placebo comparator
Placebo (Two-Step Titration)
2-step initiation regimen of volume matching placebo: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
Placebo comparator
Placebo (One-Step Titration)
1-step initiation regimen of volume matching placebo: 10 mcg QD for 2 weeks, then 20 mcg QD 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 12 (Week 24) or Day 169 if Visit 12 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. The "Placebo (Two-step Titration)" and "Placebo (One-step Titration)" Arms/Groups were combined as pre-specified in the study protocol
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 12 (Week 24) or Day 169 if Visit 12 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 12 (Week 24) or Day 169 if Visit 12 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 12 (Week 24) or Day 169 if Visit 12 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 12 (Week 24) or Day 169 if Visit 12 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-measured 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 |
|---|---|---|
| Placebo (Combined) | -0.42 | 0.099 |
| Lixisenatide (Two-Step Titration) | -0.83 | 0.099 |
| Lixisenatide (One-Step Titration) | -0.92 | 0.101 |
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Placebo (Combined) | 0.11 | 0.209 |
| Lixisenatide (Two-Step Titration) | -0.56 | 0.208 |
| Lixisenatide (One-Step Titration) | -0.53 | 0.212 |
| Group | Value (kilogram) | Spread |
|---|---|---|
| Placebo (Combined) | -1.63 | 0.385 |
| Lixisenatide (Two-Step Titration) | -2.68 | 0.385 |
| Lixisenatide (One-Step Titration) | -2.63 | 0.389 |
| Group | Value (percentage of participants) |
|---|---|
| Placebo (Combined) | 24.1 |
| Lixisenatide (Two-Step Titration) | 42.1 |
| Lixisenatide (One-Step Titration) | 47.4 |
| Group | Value (percentage of participants) |
|---|---|
| Placebo (Combined) | 7.6 |
| Lixisenatide (Two-Step Titration) | 20.4 |
| Lixisenatide (One-Step Titration) | 25.6 |
| Group | Value (percentage of participants) |
|---|---|
| Placebo (Combined) | 4.4 |
| Lixisenatide (Two-Step Titration) | 3.1 |
| Lixisenatide (One-Step Titration) | 1.3 |
| Group | Value (percentage of participants) |
|---|---|
| Placebo (Combined) | 15.2 |
| Lixisenatide (Two-Step Titration) | 25.8 |
| Lixisenatide (One-Step Titration) | 19.6 |
| Group | Value (participants) |
|---|---|
| Placebo (Combined) | 12 |
| Lixisenatide (Two-Step Titration) | 12 |
| Lixisenatide (One-Step Titration) | 6 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Placebo (Two-step Titration)2-step initiation regimen of volume matching placebo. | – | 13 / 79 | 51 / 79 |
| Placebo (One-step Titration)1-step initiation regimen of volume matching placebo. | – | 9 / 81 | 53 / 81 |
| Placebo (Combined)Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo. | – | 22 / 160 | 104 / 160 |
| Lixisenatide (Two-step Titration)2-step initiation regimen of lixisenatide. | – | 21 / 161 | 119 / 161 |
| Lixisenatide One-step Titration1-step initiation regimen of lixisenatide. | – | 16 / 161 | 101 / 161 |
| Lixisenatide (Combined)Included all patients who received 2-step initiation regimen of lixisenatide and 1-step initiation regimen of lixisenatide. | – | 37 / 322 | 220 / 322 |
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 · 2014
Bolli et al. 2014Diabetic medicine : a journal of the British Diabetic Associationcited by 108
PMID 24117597DOI 10.1111/dme.12328PUB-24117597
References listed at the registry that are not in PepBank. They link to PubMed.
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