Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
| Group | Value (percentage of hemoglobin) | Spread |
|---|---|---|
| Placebo (Combined) | -0.19 | 0.121 |
| Lixisenatide (Two-Step Titration) | -0.73 | 0.116 |
| Lixisenatide (One-Step Titration) | -0.85 | 0.119 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataShort name GETGOAL-MONO
United States, Belgium, India, Israel, Japan, Mexico, Poland, Romania, Russia, South Korea, Tunisia, 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, used in a 2-step dose titration regimen in monotherapy, over a period of 12 weeks of treatment. The primary objective is to assess the effects of lixisenatide, in comparison to placebo, on glycemic control using a 2-step dose titration regimen in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 12. Secondary objectives are to assess the effects of lixisenatide, in comparison to placebo, on glycemic control in terms of HbA1c reduction when it is used in a one-step dose titration regimen over a period of 12 weeks, body weight, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (PPG) after a standardized meal, to assess the safety and tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.
Placebo comparator
Placebo (Two-Step Titration)
2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12.
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 Week 12.
Experimental
Lixisenatide (Two-Step Titration)
2-step initiation regimen of lixisenatide: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12.
Experimental
Lixisenatide (One-Step Titration)
1-step initiation regimen of lixisenatide: 10 mcg QD for 2 weeks, then 20 mcg QD up to Week 12.
Outcomes the sponsor listed as primary.
Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
Time frame · Baseline, Week 12
Absolute change = HbA1c value at Week 12 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. 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 2-Hour Postprandial Plasma Glucose (PPG) at Week 12
Time frame · Baseline, Week 12
The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal (performed in selected sites). Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. 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 12
Time frame · Baseline, Week 12
Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. 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 12
Time frame · Baseline, Week 12
Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. 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 12
Time frame · Week 12
The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. 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 12
Time frame · Week 12
The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. 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 the Double-Blind Treatment Period
Time frame · Baseline up to Week 12
Routine fasting self monitored plasma glucose (SMPG) and central laboratory FPG 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 was performed. Threshold values for fasting SMPG/FPG: from baseline to Week 8: \>270 milligram/deciliter (mg/dL) (15 mmol/L) and from Week 8 to Week 12: \>240 mg/dL (13.3 mmol/L). 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) | -0.19 | 0.121 |
| Lixisenatide (Two-Step Titration) | -0.73 | 0.116 |
| Lixisenatide (One-Step Titration) | -0.85 | 0.119 |
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Placebo (Combined) | -0.65 | 0.563 |
| Lixisenatide (Two-Step Titration) | -4.51 | 0.572 |
| Lixisenatide (One-Step Titration) | -5.47 | 0.549 |
| Group | Value (kilogram) | Spread |
|---|---|---|
| Placebo (Combined) | -1.98 | 0.341 |
| Lixisenatide (Two-Step Titration) | -1.96 | 0.326 |
| Lixisenatide (One-Step Titration) | -1.92 | 0.338 |
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Placebo (Combined) | 0.19 | 0.255 |
| Lixisenatide (Two-Step Titration) | -0.68 | 0.247 |
| Lixisenatide (One-Step Titration) | -0.89 | 0.254 |
| Group | Value (percentage of participants) |
|---|---|
| Placebo (Combined) | 26.8 |
| Lixisenatide (Two-Step Titration) | 52.2 |
| Lixisenatide (One-Step Titration) | 46.5 |
| Group | Value (percentage of participants) |
|---|---|
| Placebo (Combined) | 12.5 |
| Lixisenatide (Two-Step Titration) | 31.9 |
| Lixisenatide (One-Step Titration) | 25.4 |
| Group | Value (percentage of participants) |
|---|---|
| Placebo (Combined) | 2.5 |
| Lixisenatide (Two-Step Titration) | 1.7 |
| Lixisenatide (One-Step Titration) | 0.8 |
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Placebo (Combined) | -0.67 | 0.447 |
| Lixisenatide (Two-Step Titration) | -3.77 | 0.454 |
| Lixisenatide (One-Step Titration) | -4.36 | 0.436 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Placebo (Two-Step Titration)2-step initiation regimen of volume matching placebo. | – | 3 / 61 | 11 / 61 |
| Placebo (One-Step Titration)1-step initiation regimen of volume matching placebo. | – | 2 / 61 | 8 / 61 |
| Placebo (Combined)Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo. | – | 5 / 122 | 19 / 122 |
| Lixisenatide (Two-Step Titration)2-step initiation regimen of lixisenatide. | – | 1 / 120 | 35 / 120 |
| Lixisenatide (One-Step Titration)1-step initiation regimen of lixisenatide. | – | 0 / 119 | 31 / 119 |
| Lixisenatide (Combined)Included all patients who received 2-step initiation regimen of lixisenatide and 1-step initiation regimen of lixisenatide. | – | 1 / 239 | 66 / 239 |
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.
1 study on this page
Indexing hint: Meta-analysis (pooled) · 2024
Natale et al. 2024The Cochrane database of systematic reviewscited by 32
PMID 38770818PMC11106805DOI 10.1002/14651858.cd015588.pub2PUB-38770818
Indexing hint: Randomized controlled trial · 2012
Fonseca et al. 2012Diabetes carecited by 167
PMID 22432104PMC3357248DOI 10.2337/dc11-1935PUB-22432104
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