Efficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients
Public ClinicalTrials.gov record NCT01798706. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter, 24 Week Study Assessing the Safety and Efficacy of Lixisenatide in Older Patients With Type 2 Diabetes Inadequately Controlled on Their Current Diabetes Treatment Regimen
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01798706
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 350 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 70 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2013 (Type not available)
- Primary completion
- Feb 2015 (Actual)
- Completion
- Feb 2015 (Actual)
- Last update posted
- Apr 18, 2017
2013 – 2015
United States locations
- U.S. sites
- 14
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840010 | La Jolla | California | 92037 | — |
| Investigational Site Number 840015 | Norwalk | California | 90650 | — |
| Investigational Site Number 840003 | Miami | Florida | 33156 | — |
| Investigational Site Number 840012 | Miami | Florida | 33156 | — |
| Investigational Site Number 840002 | Des Moines | Iowa | 50314 | — |
| Investigational Site Number 840008 | Oxon Hill | Maryland | 20745 | — |
| Investigational Site Number 840004 | Rockville | Maryland | 20852 | — |
| Investigational Site Number 840017 | Biloxi | Mississippi | 39531 | — |
| Investigational Site Number 840009 | Omaha | Nebraska | 68131 | — |
| Investigational Site Number 840016 | Salisbury | North Carolina | 28144 | — |
| Investigational Site Number 840006 | Fargo | North Dakota | 58103 | — |
| Investigational Site Number 840014 | Canal Fulton | Ohio | 44614 | — |
| Investigational Site Number 840011 | St. George | Utah | 84790 | — |
| Investigational Site Number 840007 | Milwaukee | Wisconsin | 53209 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 69 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01798706, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 18, 2017 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01798706 live on ClinicalTrials.gov.