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Type 2 Diabetes MellitusPhase 4EASENCT02954692

A Study to Evaluate the Effectiveness and Safety Initiation and Titration of Insulin Glargine (U300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus (T2DM) Controlled on Oral Antidiabetic Drug Treatment in Turkey

A Phase 4 study testing INSULIN GLARGINE (U300), metformin and sulfonylurea in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in Turkey (Türkiye).

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 assess the mean change in HbA1c (glycated haemoglobin). Secondary Objectives: To evaluate the efficacy and safety of the titration of insulin glargine U300 in terms of: Targeted HbA1c; Targeted fasting self- monitoring blood glucose (SMBG); Hypoglycemic events; Adverse events; Quality of life… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
INSULIN GLARGINE (U300), metformin and sulfonylurea
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Nov 2016to 22 Dec 2017
Phase
Phase 4
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients with type 2 diabetes mellitus (≥18 years of age).
  • Type 2 diabetes mellitus diagnosis ≥1 year.
  • Treated with ≥1 oral antidiabetics (±glucagon like peptid-1 (GLP-1) analogue) without insulin, for at least 6 months and HbA1c level between 8-11% (insulin-naïve).
  • Stable antidiabetic treatment for at least 3 months.
  • Willingness to adherence to treatment and titration (including self-injection, self- monitoring blood glucose [SMBG]).
  • Signed informed consent obtained.

Who cannot join

  • Age <18 years old.
  • Type 1 diabetes mellitus.
  • Having secondary type 2 diabetes mellitus.
  • Use of any insulin therapy including premix, basal plus/basal bolus regimen from the diagnosis.
  • History of hypoglycemia unawareness.
  • Known hypersensitivity/intolerance to insulin glargine or any of its excipients.
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  • Have any condition (including known substance or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the study protocol.
  • Use of systemic glucocorticoids for two weeks or more within 12 weeks prior to the time of screening.
  • Pregnant or lactating women.
  • Participation in another clinical trial.
  • 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

1 site in 1 country.

Turkey (Türkiye)1 site

  • Study site

    Turkey

Other trials in Turkey (Türkiye)

About this study

Official title: A National, Multicenter, Prospective, Interventional, Open-label, Single-arm, 24-Week Phase IV Study to Evaluate the Effectiveness and Safety of Initiation and Titration of Insulin Glargine U300 in Insulin-naïve Patients With T2DM Inadequately Controlled on OAD Treatment in Turkey

Primary Objective:

To assess the mean change in HbA1c (glycated haemoglobin).

Secondary Objectives:

To evaluate the efficacy and safety of the titration of insulin glargine U300 in terms of:

  • Targeted HbA1c;
  • Targeted fasting self- monitoring blood glucose (SMBG);
  • Hypoglycemic events;
  • Adverse events;
  • Quality of life assessment by DTSQs (Diabetes Treatment Satisfaction Questionnaire status) and DTSQc (Diabetes Treatment Satisfaction Questionnaire change);
  • Blood glucose fluctuation by using continuous glucose monitoring system (CGMS) in subgroup patients.
Read the detailed description

The total study duration per patient will be 27 weeks (2 weeks of screening, 24 weeks on treatment, and 1 week follow-up period).

Being tested
INSULIN GLARGINE (U300), metformin, sulfonylurea, meglitinides, thiazolidinediones
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 (U300)Drug

    Also called HOE901

    Pharmaceutical form: pen for injection

    Route of administration: subcutaneous

  • metforminDrug

    Pharmaceutical form: tablet

    Route of administration: oral

  • sulfonylureaDrug

    Pharmaceutical form: tablet

    Route of administration: oral

  • meglitinidesDrug

    Pharmaceutical form: tablet

    Route of administration: oral

  • thiazolidinedionesDrug

    Pharmaceutical form: tablet

    Route of administration: oral

  • alpha-glucosidase inhibitorsDrug

    Pharmaceutical form: tablet

    Route of administration: oral

  • GLP1 Receptor AgonistDrug

    Pharmaceutical form: pen for injection

    Route of administration: subcutaneous

  • Dipeptidyl peptidase-IV (DPP-IV) inhibitorsDrug

    Pharmaceutical form: tablet

    Route of administration: oral

  • Sodium-glucose transport-2 (SGLT-2) inhibitorsDrug

    Pharmaceutical form: tablet

    Route of administration: oral

Study groups in NCT02954692
Study groupRoleWhat they receive
Insulin glargine (U300)ExperimentalInsulin glargine (U300) will be administered daily through subcutaneous injection, and thereafter, dose will be titrated weekly (preferably 3-4 days) as needed. Background non-insulin anti-diabetic drugs approved for use in combination with insulin according to local labelling, will be permitted, with the exception of Thiazolidinediones (TZDs), which must be stopped at the time of basal insulin initiation.
Receives: Drug: INSULIN GLARGINE (U300); Drug: metformin; Drug: sulfonylurea; Drug: meglitinides; Drug: thiazolidinediones; Drug: alpha-glucosidase inhibitors; Drug: GLP1 Receptor Agonist; Drug: Dipeptidyl peptidase-IV (DPP-IV) inhibitors; Drug: Sodium-glucose transport-2 (SGLT-2) inhibitors

What is being measured

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

  1. Mean change from baseline in HbA1c

    Measured: Baseline, Week 24

Secondary outcomes (7)

  1. Percentage of patients achieving targeted fasting self-monitored blood glucose (SMBG) without experiencing severe and/or confirmed hypoglycemia ≤70mg/dL and <54 mg/dL

    Measured: At Weeks 12 and 24

  2. Percentage of patients reaching targeted fasting SMBG (80-130 mg/dL)

    Measured: At Weeks 12 and 24

  3. Duration to reach target pre-breakfast SMBG

    Measured: Baseline, Week 24

  4. Mean change from baseline in HbA1c

    Measured: Baseline, Week 12

  5. Mean change from baseline in SMBG

    Measured: Baseline, Weeks 12, and 24

  6. Mean change from baseline in fasting plasma glucose (FPG)

    Measured: Baseline, Weeks 12, and 24

  7. Mean change from baseline in Diabetes Treatment Satisfaction Questionnaire (DTSO) scores

    Measured: Baseline, 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 posted3 Nov 2016 (estimated)
  2. Study start30 Nov 2016
  3. Primary completion22 Dec 2017
  4. Study completion22 Dec 2017

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02954692
Sponsor's protocol ID
GLARGL07921
Other IDs
U1111-1183-8755
Acronym
EASE
Status last verified
Jan 2019
First submitted
2 Nov 2016
Last updated
14 Jan 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing INSULIN GLARGINE (U300), metformin and sulfonylurea in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in Turkey (Türkiye).

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 11 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 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Mean change from baseline in HbA1c (time frame: Baseline, 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 NCT02954692.

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 14 Jan 2019.

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