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Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients

NCT01476475 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 323

Last updated 2017-02-10

Study results available
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Summary

Primary Objective:

* The purpose of this study was to compare insulin glargine/ lixisenatide fixed ratio combination (FRC) versus insulin glargine on glycemic control over 24 weeks, as evaluated by glycosylated hemoglobin (HbA1c) reduction in type 2 diabetic participants treated with metformin.

Secondary Objectives:

* To compare insulin glargine/lixisenatide FRC versus insulin glargine over 24 weeks on:

* Glycemic control in relation to a meal as evaluated by post-prandial plasma glucose and glucose excursions during a standardized meal test;
* Percentage of participants reaching HbA1c \<7% or ≤6.5%;
* 7-point Self-Monitored Plasma Glucose (SMPG) profile;
* Body weight;
* Insulin glargine dose
* Fasting Plasma Glucose (FPG);
* Percentage of participants requiring rescue therapy during the 24-week open label treatment period;
* To assess safety and tolerability of insulin glargine/lixisenatide FRC.

Conditions

Interventions

DRUG

Insulin glargine /lixisenatide Fixed Ratio Combination

FRC was self-administered by subcutaneous (SC) injection within 1 hour before breakfast using pen-type injector (Tactipen®): 100 U/ml insulin glargine and 50 mcg Lixisenatide (ratio of 2 U/1 mcg). The initial dose was 10 U/5 mcg and then dose was adjusted weekly to reach and maintain fasting self-monitored plasma glucose (SMPG) of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L.

DRUG

Insulin glargine

Insulin glargine (100 U/ml) was self-administered by SC injection before breakfast using pen-type injector (Lantus® Solostar®). The initial daily dose of insulin glargine was 10 U and then dose was adjusted weekly to reach and maintain fasting SMPG of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L).

DRUG

Metformin (Background drug)

Pharmaceutical form: Tablet; Route of administration: oral administration. To be kept at stable dose (≥1.5 g/day) throughout the study.

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States
  • Chile
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Lithuania
  • Mexico
  • Poland
  • Romania
  • Slovakia
  • Sweden

Study Locations

More Related Trials

Entities

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 NCT01476475 on ClinicalTrials.gov