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Efficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients (GetGoal-O)

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ClinicalTrials.gov Identifier: NCT01798706
Recruitment Status : Completed
First Posted : February 26, 2013
Results First Posted : October 14, 2016
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Type 2 Diabetes
Interventions Drug: Lixisenatide (AVE0010)
Drug: Placebo
Drug: Antidiabetic background therapy
Enrollment 350
Recruitment Details The study was conducted at 83 centers in 13 countries. A total of 786 participants were screened between June 10, 2013 and July 09, 2014.
Pre-assignment Details A total of 426 participants underwent 4 week placebo run–in period. 436 participants were screen failures and 76 were run-in failures; the most frequent reason for screen and run-in failure was glycosylated hemoglobin (HbA1c) criteria not met at end of the run-in phase. A total of 350 participants were randomized.
Arm/Group Title Lixisenatide Placebo
Hide Arm/Group Description Lixisenatide 10 mcg subcutaneously once daily (QD) for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg. Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
Period Title: Overall Study
Started 176 174
Completed 155 153
Not Completed 21 21
Reason Not Completed
Adverse Event             15             10
Lack of Efficacy             0             2
Poor compliance to protocol             1             0
Other than specified above             5             9
Arm/Group Title Lixisenatide Placebo Total
Hide Arm/Group Description Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg. Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks. Total of all reporting groups
Overall Number of Baseline Participants 176 174 350
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 176 participants 174 participants 350 participants
74  (4) 74.4  (3.8) 74.2  (3.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 176 participants 174 participants 350 participants
Female
84
  47.7%
84
  48.3%
168
  48.0%
Male
92
  52.3%
90
  51.7%
182
  52.0%
Race  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 176 participants 174 participants 350 participants
Caucasian/white 128 122 250
Black 3 0 3
Asian/Oriental 5 11 16
Other 40 41 81
Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 176 participants 174 participants 350 participants
Hispanic 51 48 99
Not Hispanic 125 126 251
Number of Participants with Categorical BMI  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 176 participants 174 participants 350 participants
<30 kg/m^2 102 96 198
≥30 kg/m^2 74 78 152
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 176 participants 174 participants 350 participants
29.91  (3.7) 30.09  (4.53) 30.00  (4.13)
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 176 participants 174 participants 350 participants
80.81  (14.54) 80.08  (16.76) 80.45  (15.66)
HbA1c  
Mean (Standard Deviation)
Unit of measure:  Percentage of HbA1c
Number Analyzed 176 participants 174 participants 350 participants
8.04  (0.72) 8.05  (0.69) 8.04  (0.71)
Fasting Plasma Glucose (FPG)  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 176 participants 174 participants 350 participants
8.83  (2.38) 8.89  (2.26) 8.86  (2.32)
2-Hour Postprandial Plasma Glucose (PPG)   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 176 participants 174 participants 350 participants
15.18  (3.78) 14.87  (3.69) 15.03  (3.74)
[1]
Measure Description: 347 participants (174 in lixisenatide arm and 173 in placebo arm) were included for PPG analysis.
Glucose Excursion   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 176 participants 174 participants 350 participants
6.51  (3.15) 6.02  (3.17) 6.26  (3.16)
[1]
Measure Description: 345 participants (173 in lixisenatide arm and 172 in placebo arm) were included for glucose excursion analysis.
7-Point Self-monitored Plasma Glucose (SMPG)   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 176 participants 174 participants 350 participants
9.79  (2.02) 9.97  (1.98) 9.87  (2.00)
[1]
Measure Description: 333 participants (171 in lixisenatide arm and 162 in placebo arm) were included for 7 point SMPG analysis.
Duration of Diabetes  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 176 participants 174 participants 350 participants
13.63  (7.34) 14.63  (7.87) 14.13  (7.62)
1.Primary Outcome
Title Absolute Change in HbA1c From Baseline to Week 24
Hide Description Change in HbA1c was calculated by subtracting baseline value from Week 24 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.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (mITT) population: all randomized participants who received at least one dose of study drug; and had both baseline and at least one post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures.
Arm/Group Title Lixisenatide Placebo
Hide Arm/Group Description:
Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
Overall Number of Participants Analyzed 172 172
Least Squares Mean (Standard Error)
Unit of Measure: percentage of hemoglobin
-0.57  (0.075) 0.06  (0.072)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lixisenatide, Placebo
Comments Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of Week -1 HbA1c (<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 glomerular filtration rate (eGFR) (≥30 to <60, ≥60 ml/min/1.73 m^2), and country as fixed effects and baseline HbA1c value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.05 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square (LS) Mean Difference
Estimated Value -0.64
Confidence Interval (2-Sided) 95%
-0.81 to -0.464
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.088
Estimation Comments Lixisenatide vs Placebo
2.Secondary Outcome
Title Change in 2-Hour PPG From Baseline to Week 24
Hide Description The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 24 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.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline 2-hour PPG assessment during on-treatment period.
Arm/Group Title Lixisenatide Placebo
Hide Arm/Group Description:
Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
Overall Number of Participants Analyzed 147 144
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-5.12  (0.392) -0.07  (0.393)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lixisenatide, Placebo
Comments Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -1 HbA1c (<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 eGFR (≥30 to <60, ≥60 ml/min/1.73 m^2), and country as fixed effects and baseline 2-hour PPG value as a covariate. Hierarchical testing procedure was used to control type I error at 0.05. Testing was then performed sequentially in the order the endpoints were reported.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.05 level. Testing sequence continued only when previous endpoint was statistically significant at 0.05.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -5.05
Confidence Interval (2-Sided) 95%
-5.96 to -4.132
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.464
Estimation Comments Lixisenatide vs Placebo
3.Secondary Outcome
Title Change in Average 7-point SMPG Profiles From Baseline to Week 24
Hide 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 24 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.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period.
Arm/Group Title Lixisenatide Placebo
Hide Arm/Group Description:
Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
Overall Number of Participants Analyzed 138 125
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-1.15  (0.186) -0.19  (0.189)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lixisenatide, Placebo
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -1 HbA1c (<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 eGFR (≥30 to <60, ≥60 ml/min/1.73 m^2), and country as fixed effects and baseline 7-point SMPG value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.05 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.96
Confidence Interval (2-Sided) 95%
-1.39 to -0.527
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.219
Estimation Comments Lixisenatide vs Placebo
4.Secondary Outcome
Title Change in Body Weight From Baseline to Week 24
Hide Description Change in body weight was calculated by subtracting baseline value from Week 24 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.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline body weight assessment during on-treatment period.
Arm/Group Title Lixisenatide Placebo
Hide Arm/Group Description:
Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
Overall Number of Participants Analyzed 174 173
Least Squares Mean (Standard Error)
Unit of Measure: kg
-1.47  (0.241) -0.16  (0.228)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lixisenatide, Placebo
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -1 HbA1c (<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 eGFR (≥30 to <60, ≥60 ml/min/1.73 m^2), and country as fixed effects and baseline body weight value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Threshold for significance at 0.05 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.32
Confidence Interval (2-Sided) 95%
-1.862 to -0.769
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.278
Estimation Comments Lixisenatide vs Placebo
5.Secondary Outcome
Title Change in FPG From Baseline to Week 24
Hide Description Change in FPG was calculated by subtracting baseline value from Week 24 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.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline FPG assessment during on-treatment period.
Arm/Group Title Lixisenatide Placebo
Hide Arm/Group Description:
Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
Overall Number of Participants Analyzed 171 168
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.3  (0.224) 0.01  (0.218)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lixisenatide, Placebo
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -1 HbA1c (<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 eGFR (≥30 to <60, ≥60 ml/min/1.73 m^2), and country as fixed effects and baseline FPG value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2347
Comments Threshold for significance at 0.05 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.31
Confidence Interval (2-Sided) 95%
-0.828 to 0.204
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.262
Estimation Comments Lixisenatide vs Placebo
6.Secondary Outcome
Title Percentage of Participants Requiring Rescue Therapy During 24 Week Treatment Period
Hide Description Routine fasting 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 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 >9%.
Time Frame Baseline up to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Lixisenatide Placebo
Hide Arm/Group Description:
Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
Overall Number of Participants Analyzed 175 173
Measure Type: Number
Unit of Measure: percentage of participants
2.9 10.4
7.Secondary Outcome
Title Change in Plasma Glucose Excursions From Baseline to Week 24
Hide Description Plasma glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the liquid standardized breakfast meal test, before study drug administration. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 24 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.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population. Here, number of participants=participants with baseline and at least one post-baseline plasma glucose excursion assessment during on-treatment period.
Arm/Group Title Lixisenatide Placebo
Hide Arm/Group Description:
Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
Overall Number of Participants Analyzed 145 143
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-4.71  (0.331) -0.25  (0.331)
8.Secondary Outcome
Title Change in Total Daily Basal Insulin Dose From Baseline to Week 24 (in Participants Who Took Basal Insulin as Background Therapy)
Hide Description Change in basal insulin dose was calculated by subtracting baseline value from Week 24 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.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline basal insulin dose assessment during on-treatment period.
Arm/Group Title Lixisenatide Placebo
Hide Arm/Group Description:
Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
Overall Number of Participants Analyzed 54 55
Least Squares Mean (Standard Error)
Unit of Measure: units
-2.97  (1.145) -1.3  (1.076)
9.Secondary Outcome
Title Percentage of Participants With Symptomatic and Severe Symptomatic Hypoglycemia
Hide Description Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. 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.
Time Frame First dose of study drug up to 3 days after the last dose administration (maximum of 171 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety population defined as all randomized participants who received any amount of study drug.
Arm/Group Title Lixisenatide Placebo
Hide Arm/Group Description:
Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
Overall Number of Participants Analyzed 176 174
Measure Type: Number
Unit of Measure: percentage of participants
Symptomatic hypoglycemia 7.4 5.7
Severe symptomatic hypoglycemia 0.57 0
10.Secondary Outcome
Title Percentage of Participants With HbA1c Reduction >0.5% at Week 24 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia
Hide 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.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population. Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one symptomatic hypoglycemia. Otherwise, they were counted as missing.
Arm/Group Title Lixisenatide Placebo
Hide Arm/Group Description:
Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
Overall Number of Participants Analyzed 172 172
Measure Type: Number
Unit of Measure: percentage of participants
57.6 21.5
11.Secondary Outcome
Title Percentage of Participants With Gastrointestinal Disorders
Hide Description [Not Specified]
Time Frame Up to Day 171
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety population.
Arm/Group Title Lixisenatide Placebo
Hide Arm/Group Description:
Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
Overall Number of Participants Analyzed 176 174
Measure Type: Number
Unit of Measure: percentage of participants
40.3 20.7
Time Frame All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (Day 171) regardless of seriousness or relationship to investigational medicinal product (IMP).
Adverse Event Reporting Description Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the ‘on treatment period’ (time from the first dose of study drug up to 3 days after the last dose of study drug).
 
Arm/Group Title Lixisenatide Placebo
Hide Arm/Group Description Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.(Median exposure: 169 days) Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks. (Median exposure: 169 days)
All-Cause Mortality
Lixisenatide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lixisenatide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   8/176 (4.55%)   10/174 (5.75%) 
Cardiac disorders     
Acute myocardial infarction  1  0/176 (0.00%)  1/174 (0.57%) 
Angina unstable  1  1/176 (0.57%)  0/174 (0.00%) 
Bradycardia  1  0/176 (0.00%)  1/174 (0.57%) 
Gastrointestinal disorders     
Abdominal pain lower  1  0/176 (0.00%)  1/174 (0.57%) 
Pancreatitis  1  0/176 (0.00%)  1/174 (0.57%) 
General disorders     
Fatigue  1  1/176 (0.57%)  0/174 (0.00%) 
Infections and infestations     
Bronchitis  1  0/176 (0.00%)  1/174 (0.57%) 
Injury, poisoning and procedural complications     
Fall  1  1/176 (0.57%)  0/174 (0.00%) 
Hip fracture  1  1/176 (0.57%)  0/174 (0.00%) 
Skull fracture  1  1/176 (0.57%)  0/174 (0.00%) 
Spinal compression fracture  1  0/176 (0.00%)  1/174 (0.57%) 
Traumatic intracranial haemorrhage  1  1/176 (0.57%)  0/174 (0.00%) 
Musculoskeletal and connective tissue disorders     
Systemic lupus erythematosus  1  1/176 (0.57%)  0/174 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lentigo maligna  1  1/176 (0.57%)  0/174 (0.00%) 
Nervous system disorders     
Cerebrovascular accident  1  0/176 (0.00%)  1/174 (0.57%) 
Epilepsy  1  0/176 (0.00%)  1/174 (0.57%) 
Hypoglycaemic unconsciousness  1  1/176 (0.57%)  0/174 (0.00%) 
Loss of consciousness  1  0/176 (0.00%)  1/174 (0.57%) 
Transient ischaemic attack  1  0/176 (0.00%)  1/174 (0.57%) 
Renal and urinary disorders     
Renal failure acute  1  0/176 (0.00%)  1/174 (0.57%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  0/176 (0.00%)  1/174 (0.57%) 
Vascular disorders     
Aortic aneurysm  1  0/176 (0.00%)  1/174 (0.57%) 
Hypertensive crisis  1  1/176 (0.57%)  0/174 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lixisenatide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   89/176 (50.57%)   58/174 (33.33%) 
Gastrointestinal disorders     
Diarrhoea  1  19/176 (10.80%)  13/174 (7.47%) 
Nausea  1  44/176 (25.00%)  13/174 (7.47%) 
Vomiting  1  10/176 (5.68%)  1/174 (0.57%) 
Infections and infestations     
Nasopharyngitis  1  15/176 (8.52%)  22/174 (12.64%) 
Metabolism and nutrition disorders     
Hypoglycaemia  1  30/176 (17.05%)  18/174 (10.34%) 
Nervous system disorders     
Headache  1  10/176 (5.68%)  8/174 (4.60%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Name/Title: Trial Transparency Team
Organization: Sanofi
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01798706     History of Changes
Other Study ID Numbers: EFC12703
2012-003292-19 ( EudraCT Number )
U1111-1132-9156 ( Other Identifier: UTN )
First Submitted: February 22, 2013
First Posted: February 26, 2013
Results First Submitted: August 22, 2016
Results First Posted: October 14, 2016
Last Update Posted: April 18, 2017