Trial · NCT01798706
Efficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients
NCT01798706, Phase 3, Completed, Sanofi; results first posted 2016-10-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients. Trials, record NCT01798706. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01798706
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients
- NCT number
- NCT01798706
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 350 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Type 2 Diabetes
- Interventions
- Lixisenatide (AVE0010), Placebo, Antidiabetic background therapy
- First posted
- 2013-02-26
- Last updated
- 2017-04-18
- Other registries' IDs
- eudract:2012-003292-19
- Results first posted
- 2016-10-14
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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%. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Change in HbA1c From Baseline to Week 24 | Baseline, Week 24 | 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. | percentage of hemoglobin | LEAST_SQUARES_MEAN |
| SECONDARY | Change in 2-Hour PPG From Baseline to Week 24 | Baseline, Week 24 | mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline 2-hour PPG assessment during on-treatment period. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Average 7-point SMPG Profiles From Baseline to Week 24 | Baseline, Week 24 | mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Body Weight From Baseline to Week 24 | Baseline, Week 24 | mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline body weight assessment during on-treatment period. | kg | LEAST_SQUARES_MEAN |
| SECONDARY | Change in FPG From Baseline to Week 24 | Baseline, Week 24 | mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline FPG assessment during on-treatment period. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Requiring Rescue Therapy During 24 Week Treatment Period | Baseline up to Week 24 | mITT population. | percentage of participants | NUMBER |
| SECONDARY | Change in Plasma Glucose Excursions From Baseline to Week 24 | Baseline, Week 24 | mITT population. Here, number of participants=participants with baseline and at least one post-baseline plasma glucose excursion assessment during on-treatment period. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Total Daily Basal Insulin Dose From Baseline to Week 24 (in Participants Who Took Basal Insulin as Background Therapy) | Baseline, Week 24 | mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline basal insulin dose assessment during on-treatment period. | units | LEAST_SQUARES_MEAN |
| SECONDARY | 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) | Analysis was performed on safety population defined as all randomized participants who received any amount of study drug. | percentage of participants | NUMBER |
| SECONDARY | 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 | 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. | percentage of participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Change in HbA1c From Baseline to Week 24 | Lixisenatide | -0.57 | Standard Error 0.075 | percentage of hemoglobin | |
| Absolute Change in HbA1c From Baseline to Week 24 | Placebo | 0.06 | Standard Error 0.072 | percentage of hemoglobin | |
| Change in 2-Hour PPG From Baseline to Week 24 | Lixisenatide | -5.12 | Standard Error 0.392 | mmol/L | |
| Change in 2-Hour PPG From Baseline to Week 24 | Placebo | -0.07 | Standard Error 0.393 | mmol/L | |
| Change in Average 7-point SMPG Profiles From Baseline to Week 24 | Lixisenatide | -1.15 | Standard Error 0.186 | mmol/L | |
| Change in Average 7-point SMPG Profiles From Baseline to Week 24 | Placebo | -0.19 | Standard Error 0.189 | mmol/L | |
| Change in Body Weight From Baseline to Week 24 | Lixisenatide | -1.47 | Standard Error 0.241 | kg | |
| Change in Body Weight From Baseline to Week 24 | Placebo | -0.16 | Standard Error 0.228 | kg | |
| Change in FPG From Baseline to Week 24 | Lixisenatide | -0.3 | Standard Error 0.224 | mmol/L | |
| Change in FPG From Baseline to Week 24 | Placebo | 0.01 | Standard Error 0.218 | mmol/L |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lixisenatide | 176 | |
| Overall Study | STARTED | Placebo | 174 | |
| Overall Study | COMPLETED | Lixisenatide | 155 | |
| Overall Study | COMPLETED | Placebo | 153 | |
| Overall Study | NOT COMPLETED | Lixisenatide | 21 | |
| Overall Study | NOT COMPLETED | Placebo | 21 |
Source ClinicalTrials.gov
Adverse events58
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Lixisenatide | 19 | 176 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 13 | 174 | |
| other | Nausea | Gastrointestinal disorders | Lixisenatide | 44 | 176 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 13 | 174 | |
| other | Vomiting | Gastrointestinal disorders | Lixisenatide | 10 | 176 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 1 | 174 | |
| other | Nasopharyngitis | Infections and infestations | Lixisenatide | 15 | 176 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 22 | 174 | |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Lixisenatide | 30 | 176 | |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Placebo | 18 | 174 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lixisenatide | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Lixisenatide | 89 | 176 |
| Total, other adverse events | Placebo | 58 | 174 |
| Total, serious adverse events | Lixisenatide | 8 | 176 |
| Total, serious adverse events | Placebo | 10 | 174 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Lixisenatide vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01798706
GET https://conductscience.org/api/trials/v1/NCT01798706/results?page=2