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Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin

NCT01632163 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 447

Last updated 2015-06-15

No results posted yet for this study

Summary

Primary Objective:

\- To assess the effects on glycemic control of lixisenatide in comparison to placebo as an add-on treatment to basal insulin with or without metformin in terms of HbA1c reduction over a period of 24 weeks in insufficiently controlled type 2 diabetic patients.

Secondary Objectives:

* To assess the effects of lixisenatide over 24 weeks on :

* percentage of patients reaching HbA1c\<7% or ≤6.5%,
* 2-hour postprandial plasma glucose (PPG) and plasma glucose (PG) excursions during standardized meal challenge test,
* fasting plasma glucose (FPG),
* change in 7-point self-monitored plasma glucose (SMPG) profile),
* body weight,
* change in daily basal insulin dose.
* To assess lixisenatide safety and tolerability.
* To assess anti-lixisenatide antibody development.

Conditions

Interventions

DRUG

Lixisenatide (AVE0010)

Pharmaceutical form:solution Route of administration: subcutaneous injection

DRUG

Placebo

Pharmaceutical form:solution Route of administration: subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • China
  • India
  • Russia
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01632163 on ClinicalTrials.gov