Primary outcomeLeast squares mean· Baseline, Week 26
Change in HbA1c From Baseline to Week 26
| Group | Value (percentage of hemoglobin) | Spread |
|---|---|---|
| Lixisenatide | -0.63 | 0.054 |
| Insulin Glulisine QD | -0.58 | 0.054 |
| Insulin Glulisine TID | -0.84 | 0.053 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataEfficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients
Short name GetGoal-Duo-2
NCTNCT01768559 (opens ClinicalTrials.gov in a new tab)Other idEFC12626Other id2012-004096-38Other idU1111-1131-4936
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 894 participants (actual)
- Sponsor
- Sanofi · Industry
- Design
- Randomized · Open label (no masking)
- Countries
18 countries
United States, Canada, Chile, Czechia, Estonia, France, Germany, Hungary, Italy, Latvia, Lithuania, Mexico, Poland, Romania, Russia, Spain, Ukraine, United Kingdom
- Start
- Jan 2013
- Primary completion
- Dec 2014
- Completion
- Dec 2014
- First posted
- 15 Jan 2013 (estimated)
- Last update posted
- 4 Jan 2017 (estimated)
- Conditions
- Type 2 Diabetes
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201320142015
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Primary Objective: \- To compare lixisenatide versus insulin glulisine in terms of glycosylated hemoglobin (HbA1c) reduction and body weight change at Week 26 in type 2 diabetic participants not adequately controlled on insulin glargine ± metformin. Secondary Objectives: \- To compare the treatments/regimens on: * The percentage of participants reaching the target of HbA1c \<7% or ≤6.5%, * Body weight, * Self-Monitored Glucose profiles, * Fasting Plasma Glucose (FPG), * Post-prandial plasma glucose (PPG) /glucose excursions during a standardized meal test (subset of participants), * Daily doses of insulins, * Safety and tolerability.
Interventions
- Lixisenatide (AVE0010)Drug
- Insulin glulisine QDDrug
- Insulin glulisine TIDDrug
- Insulin Glargine (Mandatory background drug)Drug
- Metformin (Background drug)Drug
Arms3
Experimental
Lixisenatide
Lixisenatide 10 mcg once daily (QD) for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
Active comparator
Insulin Glulisine QD
Insulin glulisine QD from randomization up to Week 26 on top of Insulin glargine with or without metformin.
Active comparator
Insulin Glulisine TID
Insulin glulisine thrice daily (TID) from randomization up to Week 26 on top of Insulin glargine with or without metformin.
Primary outcomes2
Outcomes the sponsor listed as primary.
Change in HbA1c From Baseline to Week 26
Time frame · Baseline, Week 26
Registry description
Change in HbA1C was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last on-treatment observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.
Change in Body Weight From Baseline to Week 26
Time frame · Baseline, Week 26
Registry description
Primary outcome was the comparison between Lixisenatide versus Insulin Glulisine TID. Change in body weight was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug.
Secondary outcomes(13)
Percentage of Participants With HbA1c Level <7% and ≤6.5% at Week 26
Time frame · Week 26
Registry description
The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Missing data was imputed using LOCF.
Percentage of Participants With no Weight Gain at Week 26
Time frame · Week 26
Registry description
The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 3 days after the last dose of study drug.
Change in Average 7-point SMPG Profiles From Baseline to Week 26
Time frame · Baseline, Week 26
Registry description
Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime three times in a week before baseline, before visit Week 12 and before visit week 26 and the average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug.
Change in FPG From Baseline to Week 26
Time frame · Baseline, Week 26
Registry description
Change in FPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug.
Change in PPG From Baseline to Week 26 (in Participants Who Had an Injection of Investigational Medicinal Product [IMP] Before Breakfast)
Time frame · Baseline, Week 26
Registry description
The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.
Change in Glucose Excursions From Baseline to Week 26 (in Participants Who Had an Injection of IMP Before Breakfast)
Time frame · Baseline, Week 26
Registry description
Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change in glucose excursions was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.
Change in Insulin Glargine Dose From Baseline to Week 26
Time frame · Baseline, Week 26
Registry description
Change in Insulin glargine dose was calculated by subtracting the baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.
Insulin Glulisine Dose at Week 26
Time frame · Week 26
Registry description
The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF.
Total Insulin Dose at Week 26
Time frame · Week 26
Registry description
The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF. The outcome is reporting results of total insulin (amounts of Insulin Glargine plus Insulin Glulisine ) only for the arms in which Insulin Glulisine was administered and is not applicable for the lixisenatide arm in which only Insulin Glargine is administered. Change in dose of the insulin used by patients in the Lixisenatide arm (i.e. Insulin Glargine) is reported in the secondary Outcome Measure 9.
Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia
Time frame · First dose of study drug up to 3 days after the last dose administration (maximum of 185 days)
Registry description
Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<60 mg/dL (3.3 mmol/L). Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the participant required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.
Percentage of Participants Who Reached the Target of HbA1c <7% at Week 26 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26 Week Treatment Period
Time frame · Week 26
Registry description
The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug.
Percentage of Participants Who Reached the Target of HbA1c <7% and Had no Weight Gain at Week 26
Time frame · Week 26
Registry description
The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug.
Percentage of Participants Who Reached the Target of HbA1c <7%, Had no Weight Gain at Week 26, and Did Not Experience Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26-Week Treatment Period
Time frame · Week 26
Registry description
The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug. Participants without post-baseline on-treatment values (HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed non-response, or if they experienced at least one documented symptomatic hypoglycemia during the on-treatment period. Otherwise, they were counted as missing data.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeLeast squares mean· Baseline, Week 26
Change in Body Weight From Baseline to Week 26
| Group | Value (kg) | Spread |
|---|---|---|
| Lixisenatide | -0.63 | 0.276 |
| Insulin Glulisine QD | 1.03 | 0.276 |
| Insulin Glulisine TID | 1.37 | 0.271 |
Secondary and other outcome results(6)
Secondary outcomeNumber· Week 26
Percentage of Participants With HbA1c Level <7% and ≤6.5% at Week 26
| Group | Value (percentage of participants) |
|---|---|
| Lixisenatide | 20.5 |
| Insulin Glulisine QD | 17.8 |
| Insulin Glulisine TID | 30.8 |
Secondary outcomeNumber· Week 26
Percentage of Participants With no Weight Gain at Week 26
| Group | Value (percentage of participants) |
|---|---|
| Lixisenatide | 64.7 |
| Insulin Glulisine QD | 36.6 |
| Insulin Glulisine TID | 30.5 |
Secondary outcomeLeast squares mean· Baseline, Week 26
Change in Average 7-point SMPG Profiles From Baseline to Week 26
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Lixisenatide | -0.784 | 0.1141 |
| Insulin Glulisine QD | -0.782 | 0.1133 |
| Insulin Glulisine TID | -1.053 | 0.1105 |
Secondary outcomeLeast squares mean· Baseline, Week 26
Change in FPG From Baseline to Week 26
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Lixisenatide | -0.23 | 0.143 |
| Insulin Glulisine QD | -0.21 | 0.142 |
| Insulin Glulisine TID | -0.06 | 0.14 |
Secondary outcomeMean· Baseline, Week 26
Change in PPG From Baseline to Week 26 (in Participants Who Had an Injection of Investigational Medicinal Product [IMP] Before Breakfast)
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Lixisenatide | -3.93 | 4.29 |
| Insulin Glulisine QD | -1.62 | 4.01 |
| Insulin Glulisine TID | -1.87 | 3.18 |
Secondary outcomeMean· Baseline, Week 26
Change in Glucose Excursions From Baseline to Week 26 (in Participants Who Had an Injection of IMP Before Breakfast)
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Lixisenatide | -3.42 | 4.13 |
| Insulin Glulisine QD | -1.59 | 3.42 |
| Insulin Glulisine TID | -1.56 | 2.52 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| LixisenatideLixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin (Median exposure of 182 days). | – | 11 / 298 | 183 / 298 |
| Insulin Glulisine QDInsulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin (Median exposure of 182 days). | – | 11 / 301 | 186 / 301 |
| Insulin Glulisine TIDInsulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin (Median exposure of 182 days). | – | 14 / 294 | 195 / 294 |
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
Studies3
Studies that cite this trial.
Studies with results
1 study on this page
PubMed tag: none · 2020
Efficacy and Safety of iGlarLixi, Fixed-Ratio Combination of Insulin Glargine and Lixisenatide, Compared with Basal-Bolus Regimen in Patients with Type 2 Diabetes: Propensity Score Matched Analysis.
ÁG et al. 2020Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 20
PMID 31848983PMC6965545DOI 10.1007/s13300-019-00735-7PUB-31848983
Free to read · publisher termsCC BY-NC
Indexing hint: Randomized controlled trial · 2016
6 results
Prandial Options to Advance Basal Insulin Glargine Therapy: Testing Lixisenatide Plus Basal Insulin Versus Insulin Glulisine Either as Basal-Plus or Basal-Bolus in Type 2 Diabetes: The GetGoal Duo-2 Trial.
Rosenstock et al. 2016Diabetes carecited by 105
PMID 27222510DOI 10.2337/dc16-0014PUB-27222510
Rights unknown6 results
More studies
1 study on this page
Indexing hint: Observational study · 2018
Propensity-score-matched comparative analyses of simultaneously administered fixed-ratio insulin glargine 100 U and lixisenatide (iGlarLixi) vs sequential administration of insulin glargine and lixisenatide in uncontrolled type 2 diabetes.
Rosenstock et al. 2018Diabetes, obesity & metabolismcited by 14
PMID 29974618PMC6282993DOI 10.1111/dom.13462PUB-29974618
Free to read · publisher termsCC BY-NC-ND
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion criteria :
* Participants with type 2 diabetes mellitus diagnosed at least 1 year before screening visit (V1).
* Participants treated with basal insulin for at least 6 months.
* Participants treated for at least 3 months prior to visit 1 with a stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection). The insulin dose should be stable (± 20%) and ≥20 U/day for at least 2 months prior to visit 1.
* Participants treated with basal insulin alone or in combination with 1 to 3 oral anti-diabetic drugs (OADs) that could be: metformin (≥1.5 g/day or maximal tolerated dose), a sulfonylurea (SU), a dipeptidyl-peptidase-4 (DPP-4) inhibitor, a glinide. The dose of OADs should be stable for at least 3 months prior to visit 1.
Exclusion criteria:
* At screening: age \< legal age of majority.
* At screening, HbA1c: \<7.5% and \>10.0% for participants treated with basal insulin alone or in combination with metformin only; \< 7.0% and \> 10.0% for participants treated with basal insulin and a combination of oral anti-diabetic drugs which included a SU and/or a DPP-4 inhibitor and/or a glinide.
* Women of childbearing potential with no effective contraceptive method, pregnancy or lactation.
* Type 1 diabetes mellitus.
* Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 3 months prior to screening.
* Previous treatment with short or rapid acting insulin other than in relation to hospitalization or an acute illness.
* Any previous treatment with lixisenatide, or any discontinuation from another glucagon-like peptide 1 (GLP-1) receptor agonist due to safety/tolerability issue or lack of efficacy.
* At screening, Body Mass Index (BMI) ≤20 or \>40 kg/m\^2.
* Weight change of more than 5 kg during the 3 months prior to the screening visit; use of weight loss drugs within 3 months prior to screening.
* Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures.
* History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery.
* At screening resting systolic blood pressure \>180 mmHg or diastolic blood pressure \>95 mmHg.
* Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposed to MTC (e.g. multiple endocrine neoplasia syndromes).
* Contraindication related to metformin (for participant receiving this treatment), insulin glargine, insulin glulisine or lixisenatide.
* Participants with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease.
* At screening, amylase and/or lipase \>3 times the upper limit of the normal laboratory range (ULN).
* At screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 ULN.
* At screening calcitonin ≥20 pg/ml (5.9 pmol/L).
Exclusion Criteria for randomization at the end of the screening period before randomization:
* HbA1c \<7.0% or \>9.0%.
* 7-day mean fasting SMPG \>140 mg/dl (7.8 mmol/L).
* Amylase and/or lipase \>3 times ULN.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
PepBank is a research reference. Talk to a doctor before you use any peptide.