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Trial record 23 of 61 for:    Lixisenatide

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy (GETGOAL-MONO Japan LTS) (GETGOAL-MONO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00905255
Recruitment Status : Completed
First Posted : May 20, 2009
Results First Posted : December 21, 2016
Last Update Posted : December 21, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Drug: Lixisenatide (AVE0010)
Device: Pen auto-injector
Enrollment 69
Recruitment Details The study was conducted at 9 centers in Japan between May 09, 2009 and January 22, 2011. The overall duration of treatment was at least 76 weeks (52-week open-label treatment; 24-week open-label extension treatment).
Pre-assignment Details A total of 75 patients were screened of which 6(8.0%) were screen failures; main reasons for screen failure:glycosylated hemoglobin being out of defined protocol range (>=7% and <=10%) and use of an antidiabetic agent other than a sulfonylurea or alpha-glucosidase inhibitor within 3 months prior to screening. A total of 69 patients were randomized.
Arm/Group Title Lixisenatide (Two-step Titration) Lixisenatide (One-step Titration)
Hide Arm/Group Description 2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment. 1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to end of treatment.
Period Title: Overall Study
Started 33 [1] 36
Safety Population 33 [2] 36
Modified Intent-to-Treat(mITT)Population 33 [3] 36
Completed 20 27
Not Completed 13 9
Reason Not Completed
Adverse Event             7             5
Withdrawal by Subject             5             4
Familial and Personal Reasons             1             0
[1]
Randomized.
[2]
All patients who were exposed to at least 1 dose, regardless of amount of treatment administered.
[3]
All patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment.
Arm/Group Title Lixisenatide (Two-step Titration) Lixisenatide (One-step Titration) Total
Hide Arm/Group Description 2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment. 1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to end of treatment. Total of all reporting groups
Overall Number of Baseline Participants 33 36 69
Hide Baseline Analysis Population Description
Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 36 participants 69 participants
56.9  (9.0) 60.4  (8.2) 58.7  (8.7)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 36 participants 69 participants
Female
3
   9.1%
8
  22.2%
11
  15.9%
Male
30
  90.9%
28
  77.8%
58
  84.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants 36 participants 69 participants
Race: Asian/Oriental 33 36 69
Ethnicity: Non Hispanic 33 36 69
Glycosylated Hemoglobin (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percentage of hemoglobin
Number Analyzed 33 participants 36 participants 69 participants
8.35  (0.82) 8.12  (0.68) 8.23  (0.76)
Fasting Plasma Glucose (FPG)  
Mean (Standard Deviation)
Unit of measure:  Millimole per liter (mmol/L)
Number Analyzed 33 participants 36 participants 69 participants
9.91  (1.91) 9.16  (1.92) 9.52  (1.94)
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 33 participants 36 participants 69 participants
70.75  (19.21) 66.74  (11.14) 68.66  (15.54)
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 33 participants 36 participants 69 participants
25.16  (5.27) 24.81  (3.68) 24.98  (4.48)
[1]
Measure Description: BMI was calculated by dividing body weight by the height squared.
Duration of Diabetes   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 36 participants 69 participants
8.05  (6.38) 9.03  (7.87) 8.56  (7.16)
[1]
Measure Description: Duration of diabetes is reported at screening.
1.Primary Outcome
Title Overview of Adverse Event Profile (Treatment Emergent Adverse Events) of the One-Step and Two-Step Titration Arms Assessed Through Adverse Events Collection and Vital Signs, Electrocardiogram (ECG) and Laboratory Monitoring
Hide Description Overview of adverse event profile is reported in terms of percentage of patients with treatment emergent adverse events (TEAEs) during the 24-week treatment period: any TEAE; any serious TEAE; any TEAE leading to death; and any TEAE leading to permanent treatment discontinuation.
Time Frame First dose of study drug up to 3 days after the last dose of study drug at Week 24 or early withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
Arm/Group Title Lixisenatide (Two-step Titration) Lixisenatide (One-step Titration)
Hide Arm/Group Description:
2-step initiation regimen of lixisenatide.
1-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 33 36
Measure Type: Number
Unit of Measure: percentage of participants
Any TEAE 81.8 88.9
Any Serious TEAE 6.1 0
Any TEAE Leading to Death 0 0
Any TEAE Leading to Treatment Discontinuation 9.1 11.1
2.Secondary Outcome
Title Overview of Adverse Event Profile (Treatment Emergent Adverse Events) of All Patients During On-Treatment Period Assessed Through Adverse Events Collection and Vital Signs, ECG and Laboratory Monitoring
Hide Description Overview of adverse event profile is reported in terms of percentage of patients with TEAEs during the on-treatment period: any TEAE; any serious TEAE; any TEAE leading to death; any TEAE leading to permanent treatment discontinuation. The on-treatment period was the time from the first dose of study drug up to 3 days after the last dose at Week 76.
Time Frame First dose of study drug up to 3 days after the last dose of study drug at Week 76 or early withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified
Arm/Group Title Lixisenatide (Combined)
Hide Arm/Group Description:
Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 69
Measure Type: Number
Unit of Measure: percentage of participants
Any TEAE 91.3
Any Serious TEAE 4.3
Any TEAE Leading to Death 0
Any TEAE Leading to Treatment Discontinuation 14.5
3.Secondary Outcome
Title Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) for All Patients at Week 52 and 76
Hide Description Absolute change = HbA1c value at week of assessment (Week 52/Week 76) 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.
Time Frame Baseline, Week 52, 76
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period and “n” = patients with HbA1c assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified
Arm/Group Title Lixisenatide (Combined)
Hide Arm/Group Description:
Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: percentage of hemoglobin
Week 52 (n=47, observed cases) -0.83  (0.96)
Week 76 (n=33, observed cases) -0.72  (1.20)
4.Secondary Outcome
Title Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 52 and 76
Hide Description 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.
Time Frame Week 52, 76
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period and “n” = patients with HbA1c assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified
Arm/Group Title Lixisenatide (Combined)
Hide Arm/Group Description:
Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: percentage of participants
Week 52 (n=47, observed cases) 40.4
Week 76 (n=33, observed cases) 27.3
5.Secondary Outcome
Title Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 52 and 76
Hide Description 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.
Time Frame Week 52, 76
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period and “n” = patients with HbA1c assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified
Arm/Group Title Lixisenatide (Combined)
Hide Arm/Group Description:
Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: percentage of participants
Week 52 (n=47, observed cases) 14.9
Week 76 (n=33, observed cases) 18.2
6.Secondary Outcome
Title Change From Baseline in Body Weight for All Patients at Week 52 and 76
Hide Description Change was calculated by subtracting baseline value from value at week of assessment (Week 52/Week 76). 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.
Time Frame Baseline, Week 52, 76
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Number of patients analyzed=patients with baseline and at least 1 post-baseline weight assessment during on-treatment period and “n” = patients with weight assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified
Arm/Group Title Lixisenatide (Combined)
Hide Arm/Group Description:
Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: kilogram
Week 52 (n=47, observed cases) -1.67  (2.10)
Week 76 (n=33, observed cases) -1.58  (2.15)
7.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) for All Patients at Week 52 and 76
Hide Description Change was calculated by subtracting baseline value from value at week of assessment (Week 52/Week 76). 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.
Time Frame Baseline, Week 52, 76
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Number of patients analyzed=patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period and “n” = patients with FPG assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified
Arm/Group Title Lixisenatide (Combined)
Hide Arm/Group Description:
Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: mmol/L
Week 52 (n=47, observed cases) -0.96  (1.54)
Week 76 (n=33, observed cases) -0.46  (2.08)
8.Other Pre-specified Outcome
Title Percentage of Patients Requiring Rescue Therapy
Hide Description Routine fasting self-monitored 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 Week 4 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%, from Week 24 to end of treatment (Week 76): fasting SMPG/FPG >180 mg/dL (10.0 mmol/L) or HbA1c >8%. 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.
Time Frame Baseline up to Week 52, Baseline up to Week 76
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified
Arm/Group Title Lixisenatide (Combined)
Hide Arm/Group Description:
Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 69
Measure Type: Number
Unit of Measure: percentage of participants
Baseline up to Week 52 17.4
Baseline up to Week 76 23.2
9.Other Pre-specified Outcome
Title Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia for the One-Step and Two-Step Titration Arms During 24-Week Treatment Period
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 patient required the assistance of another person and was associated with either a plasma glucose less than 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 of study drug at Week 24 or early withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
Arm/Group Title Lixisenatide (Two-step Titration) Lixisenatide (One-step Titration)
Hide Arm/Group Description:
2-step initiation regimen of lixisenatide.
1-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 33 36
Measure Type: Number
Unit of Measure: participants
Symptomatic Hypoglycemia 2 1
Severe Symptomatic Hypoglycemia 0 0
10.Other Pre-specified Outcome
Title Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia for All Patients During On-Treatment Period
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 patient required the assistance of another person and was associated with either a plasma glucose less than 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.The on-treatment period was the time from the first dose of study drug up to 3 days after the last dose.
Time Frame First dose of study drug up to 3 days after the last dose of study drug at Week 76 or early withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified
Arm/Group Title Lixisenatide (Combined)
Hide Arm/Group Description:
Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 69
Measure Type: Number
Unit of Measure: participants
Symptomatic hypoglycemia 5
Severe symptomatic hypoglycemia 0
Time Frame First dose of study drug up to 3 days after the last dose administration up to week 76
Adverse Event Reporting Description Median exposure to study treatment was 531 and 533 days in lixisenatide two-step titration and lixisenatide one-step titration arms, respectively. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
 
Arm/Group Title Lixisenatide (Two-step Titration) Lixisenatide (One-step Titration)
Hide Arm/Group Description 2-step initiation regimen of lixisenatide. 1-step initiation regimen of lixisenatide.
All-Cause Mortality
Lixisenatide (Two-step Titration) Lixisenatide (One-step Titration)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lixisenatide (Two-step Titration) Lixisenatide (One-step Titration)
Affected / at Risk (%) Affected / at Risk (%)
Total   2/33 (6.06%)   1/36 (2.78%) 
Eye disorders     
Cataract * 1  0/33 (0.00%)  1/36 (2.78%) 
Infections and infestations     
Gastroenteritis * 1  1/33 (3.03%)  0/36 (0.00%) 
Injury, poisoning and procedural complications     
Skin laceration * 1  1/33 (3.03%)  0/36 (0.00%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion * 1  0/33 (0.00%)  1/36 (2.78%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lixisenatide (Two-step Titration) Lixisenatide (One-step Titration)
Affected / at Risk (%) Affected / at Risk (%)
Total   24/33 (72.73%)   34/36 (94.44%) 
Eye disorders     
Diabetic retinopathy * 1  2/33 (6.06%)  1/36 (2.78%) 
Gastrointestinal disorders     
Abdominal discomfort * 1  5/33 (15.15%)  6/36 (16.67%) 
Abdominal distension * 1  3/33 (9.09%)  0/36 (0.00%) 
Abdominal pain upper * 1  1/33 (3.03%)  3/36 (8.33%) 
Constipation * 1  2/33 (6.06%)  3/36 (8.33%) 
Dental caries * 1  1/33 (3.03%)  2/36 (5.56%) 
Diarrhoea * 1  1/33 (3.03%)  3/36 (8.33%) 
Dyspepsia * 1  4/33 (12.12%)  1/36 (2.78%) 
Nausea * 1  12/33 (36.36%)  18/36 (50.00%) 
Toothache * 1  3/33 (9.09%)  0/36 (0.00%) 
Vomiting * 1  4/33 (12.12%)  1/36 (2.78%) 
General disorders     
Early satiety * 1  1/33 (3.03%)  4/36 (11.11%) 
Fatigue * 1  2/33 (6.06%)  2/36 (5.56%) 
Infections and infestations     
Nasopharyngitis * 1  9/33 (27.27%)  13/36 (36.11%) 
Pharyngitis * 1  1/33 (3.03%)  2/36 (5.56%) 
Injury, poisoning and procedural complications     
Contusion * 1  2/33 (6.06%)  3/36 (8.33%) 
Investigations     
Neutrophil count decreased * 1  1/33 (3.03%)  2/36 (5.56%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  6/33 (18.18%)  7/36 (19.44%) 
Hypoglycaemia * 1 [1]  4/33 (12.12%)  2/36 (5.56%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/33 (3.03%)  2/36 (5.56%) 
Back pain * 1  2/33 (6.06%)  1/36 (2.78%) 
Periarthritis * 1  0/33 (0.00%)  2/36 (5.56%) 
Nervous system disorders     
Headache * 1  0/33 (0.00%)  2/36 (5.56%) 
Respiratory, thoracic and mediastinal disorders     
Yawning * 1  2/33 (6.06%)  0/36 (0.00%) 
Skin and subcutaneous tissue disorders     
Cold sweat * 1  0/33 (0.00%)  2/36 (5.56%) 
Heat rash * 1  1/33 (3.03%)  2/36 (5.56%) 
Urticaria * 1  1/33 (3.03%)  2/36 (5.56%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
[1]
Hypoglycaemia adverse event is based on investigator reported hypoglycaemia.
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: NCT00905255     History of Changes
Other Study ID Numbers: LTS10888
First Submitted: May 14, 2009
First Posted: May 20, 2009
Results First Submitted: August 18, 2016
Results First Posted: December 21, 2016
Last Update Posted: December 21, 2016