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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02058147




Registration number
NCT02058147
Ethics application status
Date submitted
6/02/2014
Date registered
7/02/2014
Date last updated
9/05/2017

Titles & IDs
Public title
Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin in Patients With T2DM
Scientific title
A Randomized, 30 Week, Active-controlled, Open-label, 3-treatment Arm, Parallel-group Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination to Insulin Glargine Alone and to Lixisenatide Alone on Top of Metformin in Patients With Type 2 Diabetes Mellitus (T2DM)
Secondary ID [1] 0 0
2013-003131-30
Secondary ID [2] 0 0
EFC12404
Universal Trial Number (UTN)
Trial acronym
LixiLan-O
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Insulin glargine/lixisenatide Fixed Ratio Combination
Treatment: Drugs - Insulin glargine (HOE901)
Treatment: Drugs - Lixisenatide (AVE0010)
Treatment: Drugs - Metformin

Experimental: Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) - FRC once daily (QD) for 30 weeks. Dose individually adjusted.

Active comparator: Insulin Glargine - Insulin glargine QD for 30 weeks. Dose individually adjusted.

Active comparator: Lixisenatide - Lixisenatide 10 mcg QD for 2 weeks, then 20 mcg QD (maintenance dose).


Treatment: Drugs: Insulin glargine/lixisenatide Fixed Ratio Combination
Insulin glargine/Lixisenatide FRC was self-administered by subcutaneous (SC) injection in the morning within one hour before breakfast using one of the 2 prefilled disposable SoloStar® pen-injectors: Pen A containing 100 U/mL insulin glargine (Lantus, 100 U/mL) and 50 mcg/mL lixisenatide in a ratio of 2 U:1 mcg, used for administration of doses from 10 U to 40 U (10 U/5mcg to 40 U/20mcg). Pen B containing 100 U/mL insulin glargine (Lantus, 100 U/mL) and 33 mcg/mL lixisenatide in a ratio of 3 U:1 mcg, used to administer doses from 41 U to 60 U (41 U/13 mcg to 60 U/20 mcg). The starting dose was 10 U/5 mcg. Dose was then adjusted individually 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) while avoiding hypoglycemia.

Treatment: Drugs: Insulin glargine (HOE901)
Insulin glargine (100 U/mL) was self-administered by SC injection at approximately the same time every day. Dose was adjusted individually to reach and maintain fasting SMPG of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L) while avoiding hypoglycemia.

Treatment: Drugs: Lixisenatide (AVE0010)
Lixisenatide was self-administered by SC injection within 0 to 60 minutes before breakfast or evening meal. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.

Treatment: Drugs: Metformin
Pharmaceutical form: Tablet; Route of administration: Oral administration.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in HbA1c From Baseline to Week 30
Timepoint [1] 0 0
Baseline, Week 30
Secondary outcome [1] 0 0
Percentage of Participants With HbA1c <7.0% or =6.5% at Week 30
Timepoint [1] 0 0
Week 30
Secondary outcome [2] 0 0
Change in Plasma Glucose Excursion From Baseline to Week 30
Timepoint [2] 0 0
Baseline, Week 30
Secondary outcome [3] 0 0
Change in Body Weight From Baseline to Week 30
Timepoint [3] 0 0
Baseline, Week 30
Secondary outcome [4] 0 0
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 30
Timepoint [4] 0 0
Baseline, Week 30
Secondary outcome [5] 0 0
Mean Change in 7-point Self-monitored Plasma Glucose (SMPG) Profile From Baseline to Week 30
Timepoint [5] 0 0
Baseline, Week 30
Secondary outcome [6] 0 0
Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30
Timepoint [6] 0 0
Week 30
Secondary outcome [7] 0 0
Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30 and No Documented Symptomatic Hypoglycemia (Plasma Glucose [PG] = 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period
Timepoint [7] 0 0
Baseline up to Week 30
Secondary outcome [8] 0 0
Average Daily Insulin Glargine Dose at Week 30
Timepoint [8] 0 0
Week 30
Secondary outcome [9] 0 0
Change in 2-Hour Postprandial Plasma Glucose (PPG) From Baseline to Week 30
Timepoint [9] 0 0
Baseline, Week 30
Secondary outcome [10] 0 0
Percentage of Participants Reaching HbA1c <7.0% at Week 30 With No Documented Symptomatic Hypoglycemia (PG = 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period
Timepoint [10] 0 0
Baseline up to Week 30
Secondary outcome [11] 0 0
Percentage of Participants Requiring Rescue Therapy During 30-Week Treatment Period
Timepoint [11] 0 0
Baseline up to Week 30
Secondary outcome [12] 0 0
Number of Documented Symptomatic Hypoglycemia Events Per Subject-Year
Timepoint [12] 0 0
First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)
Secondary outcome [13] 0 0
Percentage of Participants With Documented Symptomatic Hypoglycemia
Timepoint [13] 0 0
First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)
Secondary outcome [14] 0 0
Percentage of Participants With Severe Symptomatic Hypoglycemia
Timepoint [14] 0 0
First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)

Eligibility
Key inclusion criteria
Inclusion criteria:

* Participants with type 2 diabetes mellitus diagnosed for at least 1 year before the screening visit, treated for at least 3 months prior to visit 1 with metformin alone or metformin and a second oral anti-diabetic treatment that could be a sulfonylurea, a glinide, a sodium glucose co-transporter-2 inhibitor or a di-peptidyl peptidase 4 (DPP-4) inhibitors, and who were not adequately controlled with this treatment.
* Signed written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* HbA1c at screening visit:

* less than 7.5% or more than 10% for participants previously treated with metformin alone,
* less than 7.0% or more than 9% for participants previously treated with metformin and a second oral anti-diabetic treatment.
* Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
* Use of oral glucose-lowering agents other than those stated in the inclusion criteria or any injectable glucose-lowering agents during the 3 months before screening.
* Previous Treatment with insulin (except for short-term treatment due to intercurrent illness including gestational diabetes, at the discretion of the trial physician).
* History of discontinuation of a previous treatment with a glucagon-like peptide (GLP-1) receptor agonist (GLP-1 RA) due to safety/tolerability issue or lack of efficacy.
* Participant who previously participated in any clinical trial with lixisenatide or the insulin glargine/lixisenatide fixed ratio combination or had previously received lixisenatide.
* Any contraindication to metformin use, according to local labeling.
* Use of weight loss drugs within 3 months prior to screening visit.
* Within the last 6 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period.
* History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy was already performed), chronic pancreatitis, pancreatitis during a previous treatment with incretin therapies, pancreatectomy, stomach/gastric surgery.
* Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g, multiple endocrine neoplasia syndromes).
* Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 95 mmHg) at screening visit.
* At screening visit, Body Mass Index (BMI) less than or equal to 20 or above 40 kg/m^2.
* At screening visit amylase and/or lipase more than 3 times the upper limit of the normal (ULN) laboratory range.
* At screening visit alanine aminotransferase (ALT) or alkaline phosphatase (AST) more than 3 ULN.
* At screening visit calcitonin above or equal to 20 pg/mL (5.9 pmol/L).

Exclusion Criteria for randomization at the end of the screening period:

* HbA1c less than 7% or above 10%;
* Fasting Plasma glucose above 250 mg/dL (13.9 mmol/L);
* Metformin maximal tolerated dose less than 1500 mg/day;
* Amylase and/or lipase more than 3 ULN.

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2015
Sample size
Target
Accrual to date
Final
1170
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 036005 - Box Hill
Recruitment hospital [2] 0 0
Investigational Site Number 036001 - Camperdown
Recruitment hospital [3] 0 0
Investigational Site Number 036006 - Kippa Ring
Recruitment hospital [4] 0 0
Investigational Site Number 036007 - Logan Central
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [4] 0 0
4114 - Logan Central
Recruitment outside Australia
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Norwich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Rosenstock J, Aronson R, Grunberger G, Hanefeld M,... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT02058147