Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
| Group | Value (percentage of hemoglobin) | Spread |
|---|---|---|
| Placebo | -0.40 | 0.092 |
| Lixisenatide | -0.71 | 0.091 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataShort name GetGoal-Duo1
United States, Argentina, Brazil, Canada, Chile, Colombia, Czechia, Denmark, Estonia, France, Germany, Hungary, India, Israel, Italy, Malaysia, Mexico, Netherlands, Poland, Puerto Rico, Romania, Russia, South Africa, Sweden, Taiwan, 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 the study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to insulin glargine and metformin with or without thiazolidinediones (TZDs), over a period of 24 weeks of treatment. The primary objective is to assess the effects of lixisenatide in comparison to placebo, when added to insulin glargine and 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 the percentage of patients reaching HbA1c less than (\<) 7 percent (%) and less than or equal to (\<=) 6.5%, plasma glucose (fasting, postprandial during a standardized meal challenge test, 7-point self monitored profiles), body weight, insulin glargine doses, to evaluate safety and tolerability (including anti-lixisenatide antibody assessment), and to assess the impact on treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire (state) (DTSQs) in the participating countries where it is validated.
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 Week 24.
Placebo comparator
Placebo
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 Week 24.
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 the time from the first dose of study drug up to 14 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 24
Time frame · Baseline, Week 24
The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting baseline value from Week 24 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 Glucose Excursion at Week 24
Time frame · Baseline, Week 24
Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 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 Average 7-Point Self Monitored Plasma Glucose (SMPG) Profile at Week 24
Time frame · Baseline, Week 24
Patients recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime once in a week and the average value for the 7-time points was calculated. 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 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 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 Average Insulin Glargine Daily Dose at Week 24
Time frame · Baseline, Week 24
Change was calculated by subtracting the baseline value from Week 24 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 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 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 24
Time frame · Week 24
The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 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 24
Time frame · Week 24
The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 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 Period
Time frame · Baseline up to Week 24
Routine fasting SMPG, central laboratory FPG and HbA1c 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 were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG \>200 milligram/deciliter (mg/dL) (11.1 mmol/L) or HbA1c \>9%, from Week 8 to Week 24: fasting SMPG/FPG \>180 mg/dL (10.0 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.
Change From Baseline in Treatment Satisfaction Score (Sum of Items 1, 4, 5, 6, 7 and 8 of DTSQ) at Week 24
Time frame · Baseline, Week 24
Change was calculated by subtracting baseline value from Week 24 value. DTSQ: 8-item questionnaire to assess treatment satisfaction and patient perception of hyper and hypoglycemia. Each question (Q) scored on a Likert scale from 0 to 6. Six items (Q1 and 4-8; higher score = more satisfaction) measured treatment satisfaction and were summed to calculate treatment satisfaction score which ranged from 0 (very dissatisfied) to 36 (very satisfied). Two items (Q2 and 3), which were not included, measured perceived hyperglycemia and hypoglycemia, respectively and lower scores represented good perceived blood glucose control. 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.
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 | -0.40 | 0.092 |
| Lixisenatide | -0.71 | 0.091 |
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Placebo | 0.08 | 0.481 |
| Lixisenatide | -3.09 | 0.482 |
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Placebo | -0.33 | 0.461 |
| Lixisenatide | -3.42 | 0.462 |
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Placebo | -0.08 | 0.179 |
| Lixisenatide | -0.47 | 0.178 |
| Group | Value (kilogram) | Spread |
|---|---|---|
| Placebo | 1.16 | 0.330 |
| Lixisenatide | 0.28 | 0.331 |
| Group | Value (units per day) | Spread |
|---|---|---|
| Placebo | 5.34 | 1.256 |
| Lixisenatide | 3.10 | 1.260 |
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Placebo | 0.46 | 0.214 |
| Lixisenatide | 0.34 | 0.213 |
| Group | Value (percentage of participants) |
|---|---|
| Placebo | 3.2 |
| Lixisenatide | 5.1 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Placebo2-step initiation regimen of volume matching placebo. | – | 10 / 223 | 81 / 223 |
| Lixisenatide2-step initiation regimen of lixisenatide. | – | 17 / 223 | 127 / 223 |
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.
4 studies on this page
PubMed tag: none · 2023
Yao et al. 2023Diabetes therapy : research, treatment and education of diabetes and related disorders
PMID 36809495PMC10064411DOI 10.1007/s13300-023-01369-6PUB-36809495
PubMed tag: none · 2020
Davidson et al. 2020Clinical diabetes and endocrinologycited by 5
PMID 31956422PMC6961286DOI 10.1186/s40842-019-0088-5PUB-31956422
Indexing hint: Randomized controlled trial · 2013
Riddle et al. 2013Diabetes carecited by 217
PMID 23564915PMC3747901DOI 10.2337/dc12-2462PUB-23564915
Indexing hint: Randomized controlled trial · 2013
Riddle et al. 2013Diabetes carecited by 239
PMID 23628617PMC3747925DOI 10.2337/dc12-2454PUB-23628617
2 studies on this page
Indexing hint: Observational study · 2018
Rosenstock et al. 2018Diabetes, obesity & metabolismcited by 14
PMID 29974618PMC6282993DOI 10.1111/dom.13462PUB-29974618
Indexing hint: Meta-analysis (pooled) · 2014
Charbonnel et al. 2014Journal of diabetes and its complicationscited by 39
PMID 25130920DOI 10.1016/j.jdiacomp.2014.07.007PUB-25130920
Who could join, as posted.
PepBank is a research reference. Talk to a doctor before you use any peptide.
In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated