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NCT01798706 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 350
- Enrollment target
NCT01798706 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 350 participants.
The verdict
NCT01798706, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 350 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Lixisenatide (AVE0010)
- DRUG Antidiabetic background therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2013-06 |
| Est. Completion | 2015-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01798706
The ClinicalTrials.gov registry entry for NCT01798706 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01798706 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01798706 about?
NCT01798706 is a clinical study titled "Efficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients". 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 treatme...
What is the current status of trial NCT01798706?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 350 participants. The study started on 2013-06. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01798706?
The interventions under investigation include: Placebo (DRUG), Lixisenatide (AVE0010) (DRUG), Antidiabetic background therapy (DRUG).
Who is sponsoring clinical trial NCT01798706?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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