Efficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients
- Conditions
- Type 2 Diabetes
- Interventions
- Registration Number
- NCT01798706
- Lead Sponsor
- Sanofi
- Brief Summary
Primary objective:
- To evaluate the effect of lixisenatide versus placebo over a period of 24 weeks on glycemic control, as evaluated by glycosylated hemoglobin (HbA1c) reduction, in older type 2 diabetes participants (T2DM) who are inadequately controlled with their current anti-diabetic treatment regimen.
Main secondary objective:
- To assess the safety and tolerability of lixisenatide compared to placebo in older T2DM participants (including occurrence of documented (Plasma Glucose PG \< 60 mg/dL) symptomatic hypoglycemia and gastrointestinal side effects).
Other secondary objectives:
* To assess the effect of lixisenatide compared to placebo after 24-week treatment on:
* Fasting plasma glucose (FPG);
* During liquid standardized breakfast meal challenge test : 2 hour- Postprandial Plasma Glucose (PPG) and Plasma Glucose Excursion;
* 7-point Self-monitored plasma glucose (SMPG) profile;
* Body weight;
* Change in total daily dose of basal insulin (if taken);
* Percentage of participants requiring rescue therapy
* Safety and tolerability;
* To assess lixisenatide pharmacokinetic profile;
* To assess anti-lixisenatide antibody development.
- Detailed Description
Approximately 31 weeks including 24 week treatment period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 350
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lixisenatide Lixisenatide (AVE0010) Lixisenatide 10 mcg once daily (QD) for 2 weeks, 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. Lixisenatide Antidiabetic background therapy Lixisenatide 10 mcg once daily (QD) for 2 weeks, 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 Placebo Placebo (matched to lixisenatide) QD for 24 Weeks. Placebo Antidiabetic background therapy Placebo (matched to lixisenatide) QD for 24 Weeks.
- Primary Outcome Measures
Name Time Method Absolute Change in HbA1c From Baseline to Week 24 Baseline, 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.
- Secondary Outcome Measures
Name Time Method Change in FPG From Baseline to Week 24 Baseline, 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.
Change in Plasma Glucose Excursions From Baseline to Week 24 Baseline, 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.
Change in Total Daily Basal Insulin Dose From Baseline to Week 24 (in Participants Who Took Basal Insulin as Background Therapy) Baseline, Week 24 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.
Change in Body Weight From Baseline to Week 24 Baseline, 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.
Percentage of Participants With Symptomatic and Severe Symptomatic Hypoglycemia First dose of study drug up to 3 days after the last dose administration (maximum of 171 days) 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.
Percentage of Participants With HbA1c Reduction >0.5% at Week 24 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia Week 24 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.
Change in 2-Hour PPG From Baseline to Week 24 Baseline, 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.
Change in Average 7-point SMPG Profiles From Baseline to Week 24 Baseline, 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.
Percentage of Participants Requiring Rescue Therapy During 24 Week Treatment Period Baseline up to Week 24 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%.
Percentage of Participants With Gastrointestinal Disorders Up to Day 171
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Trial Locations
- Locations (83)
Investigational Site Number 840010
🇺🇸La Jolla, California, United States
Investigational Site Number 840015
🇺🇸Norwalk, California, United States
Investigational Site Number 840003
🇺🇸Miami, Florida, United States
Investigational Site Number 840012
🇺🇸Miami, Florida, United States
Investigational Site Number 840002
🇺🇸Des Moines, Iowa, United States
Investigational Site Number 840008
🇺🇸Oxon Hill, Maryland, United States
Investigational Site Number 840004
🇺🇸Rockville, Maryland, United States
Investigational Site Number 840017
🇺🇸Biloxi, Mississippi, United States
Investigational Site Number 840009
🇺🇸Omaha, Nebraska, United States
Investigational Site Number 840016
🇺🇸Salisbury, North Carolina, United States
Scroll for more (73 remaining)Investigational Site Number 840010🇺🇸La Jolla, California, United States