Clinical Trial Details
| Trial ID: | L5947 |
| Source ID: | NCT01798706 |
| Associated Drug: | Lixisenatide (Ave0010) |
| Title: | Efficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients |
| Acronym: | GetGoal-O |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT01798706/results |
| Conditions: | Type 2 Diabetes |
| Interventions: | DRUG: Lixisenatide (AVE0010)|DRUG: Placebo|DRUG: Antidiabetic background therapy |
| Outcome Measures: | Primary: Absolute 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 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., Baseline, Week 24 | Secondary: Change in 2-Hour PPG From Baseline to Week 24, 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., Baseline, 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 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., 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., 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., Baseline, Week 24|Percentage of Participants Requiring Rescue Therapy During 24 Week Treatment Period, 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%., Baseline up to Week 24|Change in Plasma Glucose Excursions From Baseline to Week 24, 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., Baseline, Week 24|Change in Total Daily Basal Insulin Dose From Baseline to Week 24 (in Participants Who Took Basal Insulin as Background Therapy), 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., Baseline, Week 24|Percentage of Participants With Symptomatic and Severe Symptomatic Hypoglycemia, 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., First dose of study drug up to 3 days after the last dose administration (maximum of 171 days)|Percentage of Participants With HbA1c Reduction >0.5% at Week 24 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia, 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., Week 24|Percentage of Participants With Gastrointestinal Disorders, Up to Day 171 |
| Sponsor/Collaborators: | Sponsor: Sanofi |
| Gender: | ALL |
| Age: | OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 350 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2013-06 |
| Completion Date: | 2015-02 |
| Results First Posted: | 2016-10-14 |
| Last Update Posted: | 2017-04-18 |
| Locations: | Investigational Site Number 840010, La Jolla, California, 92037, United States|Investigational Site Number 840015, Norwalk, California, 90650, United States|Investigational Site Number 840003, Miami, Florida, 33156, United States|Investigational Site Number 840012, Miami, Florida, 33156, United States|Investigational Site Number 840002, Des Moines, Iowa, 50314, United States|Investigational Site Number 840008, Oxon Hill, Maryland, 20745, United States|Investigational Site Number 840004, Rockville, Maryland, 20852, United States|Investigational Site Number 840017, Biloxi, Mississippi, 39531, United States|Investigational Site Number 840009, Omaha, Nebraska, 68131, United States|Investigational Site Number 840016, Salisbury, North Carolina, 28144, United States|Investigational Site Number 840006, Fargo, North Dakota, 58103, United States|Investigational Site Number 840014, Canal Fulton, Ohio, 44614, United States|Investigational Site Number 840011, St. George, Utah, 84790, United States|Investigational Site Number 840007, Milwaukee, Wisconsin, 53209, United States|Investigational Site Number 036002, Box Hill, 3128, Australia|Investigational Site Number 036006, Brookvale, 2100, Australia|Investigational Site Number 036004, Camperdown, 2050, Australia|Investigational Site Number 036005, Gosford, 2250, Australia|Investigational Site Number 036001, Heidelberg, 3081, Australia|Investigational Site Number 036003, Parkville, 3050, Australia|Investigational Site Number 100002, Plovdiv, 4002, Bulgaria|Investigational Site Number 100005, Plovdiv, 4002, Bulgaria|Investigational Site Number 100003, Sofia, 1632, Bulgaria|Investigational Site Number 100004, Stara Zagora, 6000, Bulgaria|Investigational Site Number 100001, Varna, 9000, Bulgaria|Investigational Site Number 124003, Hamilton, L8L 5G8, Canada|Investigational Site Number 124007, London, N6B 2E3, Canada|Investigational Site Number 124002, Sherbrooke, J1H 5N4, Canada|Investigational Site Number 124001, St-Romuald, G6W 5M6, Canada|Investigational Site Number 124005, Vancouver, V5Z 1M9, Canada|Investigational Site Number 124006, Vancouver, V5Z 1M9, Canada|Investigational Site Number 124008, Westmount, H3Z 1E5, Canada|Investigational Site Number 124004, Winnipeg, R3E 3P4, Canada|Investigational Site Number 208005, Esbjerg, 6700, Denmark|Investigational Site Number 208001, København Nv, 2400, Denmark|Investigational Site Number 208004, København S, 2300, Denmark|Investigational Site Number 208002, Slagelse, 4200, Denmark|Investigational Site Number 208003, Svendborg, 5700, Denmark|Investigational Site Number 276005, Dresden, 01307, Germany|Investigational Site Number 276004, Essen, 45359, Germany|Investigational Site Number 276002, München, 80639, Germany|Investigational Site Number 276001, Münster, 48145, Germany|Investigational Site Number 276006, Pirna, 01796, Germany|Investigational Site Number 276007, Pohlheim, 35415, Germany|Investigational Site Number 276008, Potsdam, 14469, Germany|Investigational Site Number 276003, Saarlouis, 66740, Germany|Investigational Site Number 578001, Hønefoss, 3515, Norway|Investigational Site Number 578005, Kongsvinger, 2212, Norway|Investigational Site Number 578003, Oslo, Norway|Investigational Site Number 578006, Stavanger, 4095, Norway|Investigational Site Number 578004, Trondheim, 7012, Norway|Investigational Site Number 604001, Arequipa, Peru|Investigational Site Number 604011, Lima, 27, Peru|Investigational Site Number 604005, Lima, LIMA 10, Peru|Investigational Site Number 604003, Lima, LIMA 14, Peru|Investigational Site Number 604006, Lima, LIMA 31, Peru|Investigational Site Number 604002, Lima, Peru|Investigational Site Number 604007, Lima, Peru|Investigational Site Number 604008, Piura, Peru|Investigational Site Number 616004, Gdansk, 80-858, Poland|Investigational Site Number 616003, Krakow, 31-024, Poland|Investigational Site Number 616001, Poznan, 61-665, Poland|Investigational Site Number 616002, Ruda Slaska, 41-709, Poland|Investigational Site Number 616006, Szczecin, 70-506, Poland|Investigational Site Number 710003, Cape Town, 7500, South Africa|Investigational Site Number 710002, Cape Town, 7530, South Africa|Investigational Site Number 710004, Somerset West, 7130, South Africa|Investigational Site Number 724001, Alcira, 46600, Spain|Investigational Site Number 724005, Barcelona, 08035, Spain|Investigational Site Number 724006, Hostalets De Balenyà, 08550, Spain|Investigational Site Number 724003, Madrid, 28046, Spain|Investigational Site Number 724002, Sanlúcar De Barrameda, 11540, Spain|Investigational Site Number 724004, Santiago De Compostela, 15706, Spain|Investigational Site Number 752006, Göteborg, 405 45, Sweden|Investigational Site Number 752007, Härnösand, 871 82, Sweden|Investigational Site Number 752002, Lund, 22221, Sweden|Investigational Site Number 752004, Malmö, 211 52, Sweden|Investigational Site Number 752003, Stockholm, 111 57, Sweden|Investigational Site Number 752001, Stockholm, 171 76, Sweden|Investigational Site Number 826003, Bexhill-On-Sea, TN39 4SP, United Kingdom|Investigational Site Number 826001, Glasgow, United Kingdom|Investigational Site Number 826002, Irvine, KA12 0AY, United Kingdom|Investigational Site Number 826004, Trowbridge, BA14 8QA, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT01798706 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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