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AzTrials

Type 2 Diabetes MellitusPhase 3NCT03529123

Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes (LixiLan-India)

A Phase 3 study testing INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010), INSULIN GLARGINE (HOE901) and Metformin in people with Type 2 Diabetes Mellitus, run by Sanofi at 13 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Primary Objective: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine by demonstrating change in glycosylated hemoglobin (HbA1c). Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010), INSULIN GLARGINE (HOE901) and Metformin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
247 participants
Where
13 sitesIndia
Study dates
19 Jun 2018to 25 Nov 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year before the screening visit,
  • At screening:
  • Age should be ≥ 18 years of age to < 65 years;
  • Glycosylated hemoglobin (HbA1c) at screening visit ≥ 7.5% or ≤ 10%;
  • Body mass index (BMI) ≥ 19 kg/m2 and ≤ 40 kg/m2.
  • Patients who have been treated with a basal insulin for at least 6 months before the screening visit, and who have been on a stable basal insulin regimen (ie, type of insulin and time/frequency of the injection), for at least 3 months before the screening visit. The stable total daily dose should be within the range of 15-40 U, both inclusive, on the day of screening, but individual fluctuations of ± 20% within 2 months prior to screening are acceptable.

Who cannot join

  • Use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria in the 3 months before screening.
  • Previous use of insulin regimen other than basal insulin eg, prandial or pre-mixed insulin (Note: Short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the investigator).
  • For patients taking metformin, any contraindication to metformin use, according to local labeling.
  • For patient not treated with metformin at screening: severe renal function impairment with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 or end-stage renal disease.
  • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (eg, multiple endocrine neoplasia syndromes).
  • Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (ie, worsening) or not controlled (ie, prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening visit; or history of surgery affecting gastric emptying.
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  • History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy.
  • Average insulin glargine daily dose <20 U or >50 U calculated for the last 3 days before Visit 6.
  • Amylase and/or lipase >3 upper limit normal (ULN) at Visit 5 (Week -1).
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

India13 sites

  • Investigational Site Number 01

    Bangalore, 560092

  • Investigational Site Number 012

    Belagavi, 590010

  • Investigational Site Number 013

    Chennai, 600086

  • Investigational Site Number 017

    Coimbatore, 641009

  • Investigational Site Number 06

    Hyderabad, 500063

  • Investigational Site Number 07

    Hyderabad, 500072

  • Investigational Site Number 08

    Jaipur

  • Investigational Site Number 04

    Kolkata, 700107

  • Investigational Site Number 018

    Lucknow

  • Investigational Site Number 014

    Madurai, 625020

  • Investigational Site Number 05

    Nashik, 422002

  • Investigational Site Number 010

    New Delhi, 110029

  • Investigational Site Number 016

    Pune, 411040

Other trials in India

About this study

Official title: A Randomized, 24-week, Controlled, Open Label, Parallel Arm, Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Type 2 Diabetes Patients, Inadequately Controlled on Basal Insulin With or Without Metformin

Primary Objective:

To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine by demonstrating change in glycosylated hemoglobin (HbA1c).

Read more

Secondary Objectives:

  • To assess the effects of the FRC in comparison with insulin glargine on:
  • Percentage of patients reaching HbA1c targets (<7% );
  • Glycemic control in relation to a meal as evaluated by 2-hour Post-prandial Plasma Glucose; (PPG);
  • Body weight
  • Fasting Plasma Glucose (FPG);
  • Percentage of patients reaching HbA1c targets of <7% with no body weight gain and no hypoglycemia (as defined in the evaluation criteria);
  • 7-point Self-Monitoring Plasma Glucose (SMPG) profile;
  • Insulin glargine dose.
  • To assess the safety and tolerability in each treatment group.
Read the detailed description

The maximum study duration per patient is 33 weeks.

Being tested
INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010), INSULIN GLARGINE (HOE901), Metformin, Insulin Glulisine (HMR1964)
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010)Drug

    Also called Soliqua, Insulin Glargine/Lixisenatide Fixed Ratio Combination

    Pharmaceutical form: Injection

    Route of administration: Subcutaneous

  • INSULIN GLARGINE (HOE901)Drug

    Also called Lantus®

    Pharmaceutical form: Injection

    Route of administration: Subcutaneous

  • MetforminDrug

    Pharmaceutical form: Tablet

    Route of administration: Oral

  • Insulin Glulisine (HMR1964)Drug

    Also called Apidra

    Pharmaceutical form: Injection

    Route of administration: Subcutaneous

Study groups in NCT03529123
Study groupRoleWhat they receive
Tested DrugExperimentalInsulin glargine/lixisenatide fixed ratio combination (FRC)
Receives: Drug: INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010); Drug: Metformin; Drug: Insulin Glulisine (HMR1964)
Control DrugActive comparatorInsulin glargine (Lantus®)
Receives: Drug: INSULIN GLARGINE (HOE901); Drug: Metformin; Drug: Insulin Glulisine (HMR1964)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c

    Mean change in glycosylated hemoglobin (HbA1c) from baseline to Week 24

    Measured: From baseline to Week 24

Secondary outcomes (8)

  1. Patients with HbA1c <7%

    Number of patients reaching HbA1c <7 % at the end of Week 24

    Measured: At Week 24

  2. Change in 2-hour Post prandial glucose (PPG)

    Change in 2-hour PPG from baseline to Week 24

    Measured: From baseline to Week 24

  3. Change in body weight

    Change in body weight from baseline to Week 24

    Measured: From baseline to Week 24

  4. Patients with HbA1c <7% with no body weight gain and no hypoglycemia

    Number of patients reaching HbA1c <7% with no body weight gain and no hypoglycemia at the end of Week 24

    Measured: At Week 24

  5. Change in Fasting Plasma Glucose

    Mean change in FPG from baseline to Week 24

    Measured: From baseline to Week 24

  6. Adverse events (AE)

    Number of AEs

    Measured: Up to 33 weeks

  7. Patients with HbA1c <7% with no body weight gain

    Number of patients reaching HbA1c <7% with no body weight gain at the end of Week 24

    Measured: At Week 24

  8. Change in SMPG profiles

    Change in 7-point self-monitoring plasma glucose (SMPG) profiles from baseline to Week 24

    Measured: From baseline to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2018
  2. Study start19 Jun 2018
  3. Primary completion25 Nov 2019
  4. Study completion25 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
247 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03529123
Sponsor's protocol ID
INSLIL08556
Other IDs
U1111-1200-1162
Status last verified
Apr 2022
First submitted
7 May 2018
Last updated
25 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010), INSULIN GLARGINE (HOE901) and Metformin in people with Type 2 Diabetes Mellitus, run by Sanofi at 13 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (time frame: From baseline to Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03529123.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.

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