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Efficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients

NCT01798706 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2017-04-18

Study results available
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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.

Conditions

Interventions

DRUG

Lixisenatide (AVE0010)

Pharmaceutical form: Solution for injection in pre-filled pen administered 30 to 60 minutes before breakfast in the morning Route of administration: Subcutaneous injection

DRUG

Placebo

Pharmaceutical form: Solution for injection in pre-filled pen administered 30 to 60 minutes before breakfast in the morning Route of administration: Subcutaneous injection

DRUG

Antidiabetic background therapy

Participants received a stable regimen of anti-diabetic background therapy for at least 3 months prior to screening, during the placebo run-in period and the 24 week treatment period. Allowed background antidiabetic therapy included metformin, sulfonylurea (except glibenclamide \>10 mg, gliclazide \>160 mg), meglitinides (except repaglinide \>6 mg), pioglitazone and basal insulin. Insulin glargine, neutral protamine hagedorn (NPH) insulin, detemir, lente and ultralente were considered as basal insulin.

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States
  • Australia
  • Bulgaria
  • Canada
  • Denmark
  • Germany
  • Norway
  • Peru
  • Poland
  • South Africa
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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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 NCT01798706 on ClinicalTrials.gov