Clinical Trial Details
| Trial ID: | L3884 |
| Source ID: | NCT01517412 |
| Associated Drug: | Lixisenatide (Ave0010) |
| Title: | Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT01517412/results |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: Lixisenatide (AVE0010)|DEVICE: Self-injector pen device (OptiClik®)|DRUG: Metformin |
| Outcome Measures: | Primary: Change in HbA1c From Baseline to Week 24, Change in HbA1C was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last 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., Baseline, Week 24 | Secondary: Percentage of Participants With HbA1c Level <7 % or ≤6.5% at Week 24, Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period., Week 24|Change in Average 7-point SMPG Profiles From Baseline to Week 24, Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime two times in a week before baseline, before visit Week 8, before visit Week 12 and before visit week 24. 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. Here, number of participants analyzed = participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period., Baseline, Week 24|Change in FPG From Baseline to Week 24, 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. Here, number of participants analyzed = participants with baseline and at least one post-baseline FPG assessment during on-treatment period., Baseline, Week 24|Change in Body Weight From Baseline to Week 24, 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. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period., Baseline, Week 24|Percentage of Participants Who Reached the Target of HbA1c <7% at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (Plasma Glucose [PG] <60 mg/dL [3.3 mmol/L]) During 24-Week Treatment Period, Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemic episode with an accompanying PG\<60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate if no PG measurement was available. On-treatment period for symptomatic hypoglycemia assessment was defined as time from first dose of study drug up to 1 day after last dose of study drug. 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., Week 24|Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24, Participants without post-baseline on-treatment values for (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 no response. Otherwise, they were counted as missing., Week 24|Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (PG<60 mg/dL [3.3 mmol/L]) During the 24-Week Treatment Period, Participants without post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart not more than 30-days apart were counted as non-responders if at least one of components (HbA1c and/or body weight) was available and showed no response. Otherwise, they were counted as missing., Week 24|Percentage of Participants Who Reached the Target of HbA1c <7% And Had a 2-hour Postprandial Plasma Glucose (PPG) <140mg/dL After Breakfast or Main Meal At Week 24, On-treatment period for 2-hour PPG assessment was defined as the time from the first dose of study drug up to the day of last dose of study drug. Participants without post-baseline on-treatment values (for HbA1c and 2-hour PPG) that were no more than 30-days apart were counted as non-responders if at least one of the components (HbA1cand/or 2-hour PPG) was available and showed no response. Otherwise, they were counted as missing., Week 24|Change in Diabetes Treatment Satisfaction Questionnaire Score (DTSQs) From Baseline to Week 24, DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1, 4, 5, 6, 7 and 8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. On-treatment period for treatment satisfaction assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. Missing data was imputed using LOCF. Here, number of participants analyzed = participants with both baseline and Week 24 DTSQ score assessment during on-treatment period., Baseline, Week 24 |
| Sponsor/Collaborators: | Sponsor: Sanofi |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 451 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2012-02 |
| Completion Date: | 2013-05 |
| Results First Posted: | 2016-10-14 |
| Last Update Posted: | 2016-10-14 |
| Locations: | Investigational Site Number 840112, Glendale, Arizona, 85306, United States|Investigational Site Number 840113, Mesa, Arizona, 85213, United States|Investigational Site Number 840105, Phoenix, Arizona, 85028, United States|Investigational Site Number 840102, Tempe, Arizona, 85282, United States|Investigational Site Number 840107, Tempe, Arizona, United States|Investigational Site Number 840116, Mission Viejo, California, 92691, United States|Investigational Site Number 840103, Northridge, California, 91325, United States|Investigational Site Number 840118, Redlands, California, 92374, United States|Investigational Site Number 840104, Temecula, California, 92591, United States|Investigational Site Number 840122, Chicago, Illinois, 60611, United States|Investigational Site Number 840119, Chicago, Illinois, 60616, United States|Investigational Site Number 840114, Springfield, Illinois, 62704, United States|Investigational Site Number 840120, Flint, Michigan, 48504, United States|Investigational Site Number 840115, Billings, Montana, 59103, United States|Investigational Site Number 840101, Sea Girt, New Jersey, 08750, United States|Investigational Site Number 840111, Fargo, North Dakota, 58103, United States|Investigational Site Number 840110, West Jordan, Utah, 84088, United States|Investigational Site Number 124102, Brampton, L6R 3J5, Canada|Investigational Site Number 124108, Coquitlam, V3K 3P4, Canada|Investigational Site Number 124106, Etobicoke, M9R 4E1, Canada|Investigational Site Number 124113, Kelowna, V1Y 1Z9, Canada|Investigational Site Number 124110, Laval, H7T 2P5, Canada|Investigational Site Number 124103, Newmarket, L3Y 5G8, Canada|Investigational Site Number 124101, Oakville, L6H 3P1, Canada|Investigational Site Number 124111, St-Romuald, G6W 5M6, Canada|Investigational Site Number 124104, Thornhill, L4J 8L7, Canada|Investigational Site Number 124105, Toronto, M9V 4B4, Canada|Investigational Site Number 124112, Vancouver, V5Z 1M9, Canada|Investigational Site Number 203104, Plzen, 32600, Czech Republic|Investigational Site Number 203102, Praha 10, 10000, Czech Republic|Investigational Site Number 203101, Praha 10, 10034, Czech Republic|Investigational Site Number 203105, Praha 2, 12808, Czech Republic|Investigational Site Number 203103, Trutnov, 54101, Czech Republic|Investigational Site Number 203106, Ujezd U Brna, 664 53, Czech Republic|Investigational Site Number 250108, Clermont Ferrand, 63000, France|Investigational Site Number 250102, Menton, 06500, France|Investigational Site Number 250103, Nanterre, 92014, France|Investigational Site Number 250105, Rennes, 35700, France|Investigational Site Number 276103, Asslar, 35614, Germany|Investigational Site Number 276102, Bad Mergentheim, 97980, Germany|Investigational Site Number 276107, Berlin, 13125, Germany|Investigational Site Number 276101, Heidelberg, 69115, Germany|Investigational Site Number 276104, Künzing, 94550, Germany|Investigational Site Number 276105, Pirna, 01796, Germany|Investigational Site Number 276108, St. Ingbert-Oberwürzbach, 66386, Germany|Investigational Site Number 616106, Bytom, 41-902, Poland|Investigational Site Number 616102, Gdansk, 80-858, Poland|Investigational Site Number 616101, Krakow, 31-450, Poland|Investigational Site Number 616103, Lublin, 20-538, Poland|Investigational Site Number 616108, Oswiecim, 32-600, Poland|Investigational Site Number 616105, Wroclaw, 50-127, Poland|Investigational Site Number 616104, Wroclaw, 50-306, Poland|Investigational Site Number 616107, Wroclaw, 50-403, Poland|Investigational Site Number 642101, Bucuresti, 050538, Romania|Investigational Site Number 642105, Oradea, 410169, Romania|Investigational Site Number 642102, Ploiesti, 100097, Romania|Investigational Site Number 642104, Resita, 320076, Romania|Investigational Site Number 642103, Timisoara, 300456, Romania|Investigational Site Number 643103, Moscow, 119435, Russian Federation|Investigational Site Number 643101, Moscow, 125367, Russian Federation|Investigational Site Number 643106, Nizhny Novgorod, 603018, Russian Federation|Investigational Site Number 643102, Samara, 443067, Russian Federation|Investigational Site Number 643107, St-Petersburg, 194291, Russian Federation|Investigational Site Number 643105, St-Petersburg, 194354, Russian Federation|Investigational Site Number 643110, St-Petersburg, 195257, Russian Federation|Investigational Site Number 643108, Vladimir, 600023, Russian Federation|Investigational Site Number 643104, Voronezh, 394018, Russian Federation|Investigational Site Number 724104, Barcelona, 08020, Spain|Investigational Site Number 724103, Barcelona, 08041, Spain|Investigational Site Number 724102, El Ferrol, 15403, Spain|Investigational Site Number 724101, Hostalets De Balenyà, 08550, Spain|Investigational Site Number 724107, La Coruña, 15006, Spain|Investigational Site Number 724106, Málaga, 29010, Spain|Investigational Site Number 724108, Segovia, 40002, Spain|Investigational Site Number 724105, Sevilla, 41014, Spain|Investigational Site Number 804108, Kharkiv, 61002, Ukraine|Investigational Site Number 804105, Kharkov, 61022, Ukraine|Investigational Site Number 804102, Kiev, 2091, Ukraine|Investigational Site Number 804103, Kyiv, 04114, Ukraine|Investigational Site Number 804104, Mykolaiv, 54003, Ukraine|Investigational Site Number 804106, Poltava, 36011, Ukraine|Investigational Site Number 804101, Zaporozhie, 69600, Ukraine |
| URL: | https://clinicaltrials.gov/show/NCT01517412 |
