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

December 16, 2016 updated by: Sanofi

A Randomized, 24-week, Open-label, 2-arm Parallel-group, Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine on Top of Metformin in Type 2 Diabetic Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Approximately 27 weeks including a 24-week treatment period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
323

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile, 7500347
        • Investigational Site Number 152404
      • Santiago, Chile, 7500347
        • Investigational Site Number 152405
      • Santiago, Chile, 7500710
        • Investigational Site Number 152403
      • Santiago, Chile, 7980378
        • Investigational Site Number 152401
      • Santiago, Chile, 8320000
        • Investigational Site Number 152402
  • Czech Republic
      • Novy Jicin, Czech Republic, 74101
        • Investigational Site Number 203403
      • Plzen, Czech Republic, 32600
        • Investigational Site Number 203401
      • Praha 2, Czech Republic, 12808
        • Investigational Site Number 203402
      • Praha 8, Czech Republic, 18100
        • Investigational Site Number 203405
  • Denmark
      • København Nv, Denmark, 2400
        • Investigational Site Number 208401
      • Køge, Denmark, 4600
        • Investigational Site Number 208404
      • Slagelse, Denmark, 4200
        • Investigational Site Number 208402
      • Svendborg, Denmark, 5700
        • Investigational Site Number 208403
  • France
      • Narbonne, France, 11018
        • Investigational Site Number 250402
      • Poitiers Cedex, France, 86021
        • Investigational Site Number 250404
      • Vandoeuvre Les Nancy, France, 54511
        • Investigational Site Number 250401
  • Germany
      • Dresden, Germany, 01307
        • Investigational Site Number 276401
      • Ludwigshafen, Germany, 67059
        • Investigational Site Number 276402
      • Oberhausen, Germany, 46045
        • Investigational Site Number 276403
  • Hungary
      • Balatonfüred, Hungary, 8230
        • Investigational Site Number 348401
      • Budapest, Hungary, 1041
        • Investigational Site Number 348405
      • Budapest, Hungary, 1212
        • Investigational Site Number 348406
      • Debrecen, Hungary, 4043
        • Investigational Site Number 348404
      • Szeged, Hungary, 6720
        • Investigational Site Number 348402
      • Szeged, Hungary, 6722
        • Investigational Site Number 348403
  • Lithuania
      • Kaunas, Lithuania, LT-49456
        • Investigational Site Number 440401
      • Kaunas, Lithuania, LT-51270
        • Investigational Site Number 440402
      • Kedainiai, Lithuania, LT-57164
        • Investigational Site Number 440403
      • Klaipeda, Lithuania, LT-92304
        • Investigational Site Number 440404
  • Mexico
      • Acapulco, Mexico, 39670
        • Investigational Site Number 484404
      • Cuernavaca, Mexico, 62250
        • Investigational Site Number 484401
      • Durango, Mexico, 34270
        • Investigational Site Number 484405
      • Guadalajara, Mexico, 44210
        • Investigational Site Number 484402
      • Guadalajara, Mexico, 44656
        • Investigational Site Number 484403
  • Poland
      • Bialystok, Poland, 15-435
        • Investigational Site Number 616405
      • Gdansk, Poland, 80-847
        • Investigational Site Number 616406
      • Krakow, Poland, 31-548
        • Investigational Site Number 616403
      • Lodz, Poland, 94-074
        • Investigational Site Number 616407
      • Pulawy, Poland, 24-100
        • Investigational Site Number 616404
      • Szczecin, Poland, 70-506
        • Investigational Site Number 616402
      • Warszawa, Poland, 02-507
        • Investigational Site Number 616401
  • Romania
      • Brasov, Romania, 500365
        • Investigational Site Number 642402
      • Bucuresti, Romania, 020475
        • Investigational Site Number 642403
      • Iasi, Romania, 700547
        • Investigational Site Number 642405
      • Oradea, Romania, 410169
        • Investigational Site Number 642401
      • Targu Mures, Romania, 540142
        • Investigational Site Number 642406
      • Timisoara, Romania, 300133
        • Investigational Site Number 642404
  • Slovakia
      • Bratislava, Slovakia, 85101
        • Investigational Site Number 703402
      • Kosice, Slovakia, 04001
        • Investigational Site Number 703403
      • Kosice, Slovakia, 04013
        • Investigational Site Number 703406
      • Moldava Nad Bodvou, Slovakia, 04525
        • Investigational Site Number 703404
      • Nitra, Slovakia, 94911
        • Investigational Site Number 703405
      • Zilina, Slovakia, 01001
        • Investigational Site Number 703401
  • Sweden
      • Skellefteå, Sweden, 931 32
        • Investigational Site Number 752402
      • Stockholm, Sweden, 171 76
        • Investigational Site Number 752401
      • Växjö, Sweden, 351 85
        • Investigational Site Number 752403
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Investigational Site Number 840408
    • California
      • Paramount, California, United States, 90723
        • Investigational Site Number 840412
    • Georgia
      • Larenceville, Georgia, United States, 30045
        • Investigational Site Number 840401
      • Roswell, Georgia, United States, 30076
        • Investigational Site Number 840417
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Investigational Site Number 840403
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • Investigational Site Number 840404
      • Rockville, Maryland, United States, 20852
        • Investigational Site Number 840405
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Investigational Site Number 840411
    • New York
      • West Seneca, New York, United States, 14224
        • Investigational Site Number 840415
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Investigational Site Number 840402
    • Oregon
      • Medford, Oregon, United States, 97504
        • Investigational Site Number 840407
    • Pennsylvania
      • Durham, Pennsylvania, United States, 27713
        • Investigational Site Number 840413
    • Texas
      • Dallas, Texas, United States, 75230
        • Investigational Site Number 840410
    • Washington
      • Renton, Washington, United States, 98055
        • Investigational Site Number 840414

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Participants with type 2 diabetes mellitus diagnosed for at least 1 year.
  • Metformin treatment at a stable dose of at least 1.5 g/day for at least 3 months prior to screening.

Exclusion criteria:

  • Age < legal age of adulthood (18 years).
  • Screening HbA1c <7% or >10%.
  • Screening FPG >250 mg/dL (>13.9 mmol/L).
  • Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
  • Type 1 diabetes mellitus.
  • Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening.
  • Use of insulin within the last 6 months.
  • Previous use of insulin, except for episode(s) of short-term treatment (≤15 consecutive days) due to intercurrent illness.
  • Amylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN) at screening.
  • Calcitonin ≥20 pg/ml (5.9 pmol/l) at screening.
  • Alanine Transferase (ALT) >3 ULN at screening.
  • History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy.
  • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes).
  • Uncontrolled or inadequately controlled hypertension at the time of screening with a resting supine systolic or diastolic blood pressure >180 mmHg or >110 mmHg, respectively.
  • Within the last 6 months prior to screening: history of heart failure requiring hospitalization, myocardial infarction, or stroke. Planned coronary, carotid or peripheral artery revascularisation procedures.
  • Body Mass Index (BMI) ≤20 or >40 kg/m^2.
  • Any previous treatment with lixisenatide

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Insulin glargine/Lixisenatide Fixed Ratio Combination (FRC)
FRC injected once daily (QD) for 24 weeks. Dose individually adjusted.
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.
Other Names:
  • (HOE901/AVE0010)
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.
Active Comparator: Insulin glargine
Insulin glargine QD for 24 weeks. Dose individually adjusted.
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.
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).
Other Names:
  • Lantus

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in HbA1c From Baseline to Week 24
Time Frame: Baseline, Week 24
Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of investigational medicinal product (IMP).
Baseline, Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in 2-hour Postprandial Plasma Glucose (PPG) From Baseline to Week 24
Time Frame: Baseline, Week 24
The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.
Baseline, Week 24
Change in 2-hour Plasma Glucose Excursion From Baseline to Week 24
Time Frame: Baseline, Week 24
2-hour plasma glucose excursion = 2-hour PPG minus plasma glucose value obtained 30 minutes prior to the start of the meal and before IMP administration. Change in plasma glucose excursion was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.
Baseline, Week 24
Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profiles From Baseline to Week 24
Time Frame: Baseline, Week 24
Participants recorded a 7-point plasma glucose profile measured before and 2-hours after each meal and at bedtime, over a single day, once in a week before baseline, before visit Week 12 and before visit Week 24 and the average value across the profiles performed in the week before a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.
Baseline, Week 24
Change in Body Weight From Baseline to Week 24
Time Frame: Baseline, Week 24
Change in body weight was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 3 days after the last injection of IMP.
Baseline, Week 24
Average Daily Insulin Glargine Dose at Week 24
Time Frame: Week 24
Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.
Week 24
Change in FPG From Baseline to Week 24
Time Frame: Baseline, Week 24
Change in FPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 1 day after the last injection of IMP.
Baseline, Week 24
Percentage of Participants Requiring Rescue Therapy During 24-week Treatment Period
Time Frame: Baseline up to Week 24
Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceed the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) were performed. Threshold values from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 30: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8%.
Baseline up to Week 24
Percentage of Participants With HbA1c ≤6.5 % or <7.0 % at Week 24
Time Frame: Week 24
On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of IMP.
Week 24
Change in 30-minute and 1-hour PPG From Baseline to Week 24
Time Frame: Baseline, Week 24
The 30 minute and 1-hour PPG test measured blood glucose 30 minutes and 1-hour after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.
Baseline, Week 24
Change in 30 Minute and 1-hour Plasma Glucose Excursion From Baseline to Week 24
Time Frame: Baseline, Week 24
30-minute and 1-hour plasma glucose excursion = 30-minute and 1-hour PPG minus plasma glucose value obtained 30 minutes prior to the start of the meal and before IMP administration. Change in plasma glucose excursion was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.
Baseline, Week 24
Percentage of Participants Reaching HbA1c <7% at Week 24 With no Documented Symptomatic Hypoglycemia During 24-week Treatment Period
Time Frame: Baseline up to Week 24
Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L). Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one documented symptomatic hypoglycemia before the introduction of rescue medication and up to 1 day after the last injection of IMP. Otherwise, they were counted as missing data. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of IMP.
Baseline up to Week 24
Percentage of Participants Reaching HbA1c <7% With no Body Weight Gain at Week 24
Time Frame: Week 24
Participants without any post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (for HbA1c and body weight) was available and showed non-response. Otherwise, they were counted as missing data.
Week 24
Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia
Time Frame: First dose of study drug up to 3 days after the last dose administration (maximum of 219 days)
Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).Severe symptomatic hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes were associated with sufficient neuroglycopenia to induce seizure, unconsciousness or coma. All episodes in which neurological impairment was severe enough to prevent self-treatment and which were thought to place participants at risk for injury to themselves or others.
First dose of study drug up to 3 days after the last dose administration (maximum of 219 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ACT12374
  • 2011-002090-36 (EudraCT Number)
  • U1111-1121-7111 (Other Identifier: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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