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Diabetes Mellitus, Type 2Phase 4ATLASNCT01169818

Evaluation of the Effectiveness and Safety of Physician Versus Patient-led of Insulin Glargine Initiation and Titration in Type 2 Diabetes Mellitus

A Phase 4 study testing Insulin Glargine in people with Diabetes Mellitus, Type 2, run by Sanofi at 6 sites in 6 countries.

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 compare patient-led titration (intervention group) versus physician-led titration (usual standard of care) in optimizing the clinical use of insulin glargine in an Asian population of patients with Type 2 diabetes mellitus (T2DM) uncontrolled on oral antidiabetic drugs (OADs). Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Insulin Glargine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
555 participants
Where
6 sitesin 6 countries
Study dates
Aug 2010to Jun 2012
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 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with T2DM duration of T2DM > 2 years
  • Insulin naïve
  • Continuous treatment with stable doses of 2 OADs (sulphonylureas, biguanides, alpha-glucosidase inhibitors, DPP-IV inhibitors, and glinides) for > three months prior to randomization
  • HbA1c levels 7% and 11 %
  • Body mass index (BMI) 20 and 40 kg/m2
  • Willing and able to perform blood glucose monitoring using a blood glucose meter

Who cannot join

  • Diabetes other than type 2 diabetes (e.g. secondary to pancreatic disorders, drug or chemical agent intake),
  • Current or previous use of insulin (except for previous treatment of gestational diabetes or brief treatment with insulin for < 1 week),
  • Current treatment with thiazolidinediones,
  • Current or previous use (within the last 3 months) of GLP-1 receptor agonists or GLP-1 analogues,
  • Current or previous (within the last 3 months) use of any treatment for weight lost,
  • Active proliferative diabetic retinopathy,
Show all 27Show fewer
  • Patient without any history of eye examination in the past 6 months,
  • Treatment with systemic corticosteroids in the 3 months prior to study entry,
  • Currently receiving treatment with monoamine oxidase inhibitors,
  • Currently receiving treatment with non-selective -blockers,
  • Treatment with any investigational product and/or device in the 2 months prior to study entry,
  • Likelihood of requiring treatment during the study period with drugs not permitted by the clinical trial protocol,
  • History of ketoacidosis or hyperosmolar hyperglycemic state,
  • History of stroke, myocardial infarction, angina pectoris, coronary artery bypass graft or percutaneous transluminal coronary angioplasty within the previous 12 months,
  • History of congestive heart failure,
  • History of hypoglycemia unawareness,
  • Unexplained hypoglycemia in the past 6 months,
  • Impaired renal function defined as, but not limited to, serum creatinine 1.5 mg/dL (133 mol/L) males or 1.4 mg/dL (124 mol/L) females or presence of macroproteinuria (>2gr/day),
  • Active liver disease (alanine transaminase ALAT greater than two times the upper limit of the reference range, as defined by the local laboratory),
  • Have any condition (including known substance or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the study protocol,
  • Had a blood transfusion or severe blood loss within the 3 months before screening, or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia,
  • Known hypersensitivity / intolerance to insulin glargine or any of its excipients,
  • History of pancreatitis,
  • Currently undergoing therapy or planned radiological examinations requiring the administration of contrasting agents for malignancy (other than non-metastatic / early stage basal cell or squamous cell carcinoma),
  • Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method),
  • Any medical condition that may have an influence on HbA1c rate.
  • 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

6 sites in 6 countries.

6 sites in 6 countries

China1 site

  • Administrative office

    Shanghai

Other trials in China

India1 site

  • Administrative office

    Mumbai

Other trials in India

Japan1 site

  • Administrative office

    Tokyo

Other trials in Japan

Pakistan1 site

  • Administrative office

    Karachi

Other trials in Pakistan

Philippines1 site

  • Administrative office

    Makati City

Other trials in Philippines

Russia1 site

  • Administrative office

    Moscow

Other trials in Russia

About this study

Official title: Asian Treat to Target Lantus Study: A Randomized, Multicentre, Multinational, Open-Label, Parallel-Group, 24-Week Phase IV Study Evaluating the Effectiveness and Safety of Physician Versus Patient-led Initiation and Titration of Insulin Glargine in Type 2 Diabetes Mellitus

Primary Objective:

To compare patient-led titration (intervention group) versus physician-led titration (usual standard of care) in optimizing the clinical use of insulin glargine in an Asian population of patients with Type 2 diabetes mellitus (T2DM) uncontrolled on oral antidiabetic drugs (OADs).

Secondary Objectives:

To determine the difference in glycemic control, safety, quality of life and treatment satisfaction between patient-led titration and usual care.

Being tested
Insulin Glargine
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 GlargineDrug

    Also called Solostar

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous

    Dose regimen: initial: once a day in the evening at bedtime. Titration will occur each time the middle FPG (Fasting Plasma Glucose) value is above target

Study groups in NCT01169818
Study groupRoleWhat they receive
Intervention groupExperimentalInitiation on a fixed dose of insulin glargine, then subjects will self-adjusted their basal insulin dose every 3 days
Receives: Drug: Insulin Glargine
Usual standard of care groupActive comparatorInitiation on a fixed dose of insulin glargine, then basal insulin dose is adjusted at each visit by a physician
Receives: Drug: Insulin Glargine

What is being measured

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

  1. Change (decrease) in mean hemoglobin glycosylated (HbA1c) level

    Measured: from week 0 (baseline) to week 24 (end of study)

Secondary outcomes (11)

  1. Percentage of patients achieving HbA1c levels < 7.0% without experiencing severe hypoglycemia

    Measured: from week 0 (baseline) to week 24 (end of study)

  2. Percentage of patients achieving target HbA1c levels (< 7.0% and <6.5%)

    Measured: from week 0 (baseline) to week 24 (end of study)

  3. Number of patients having a drop of 1% in HbA1c levels and/or a drop of at least 0.5%.

    Measured: from week 0 (baseline) to week 24 (end of study)

  4. Mean change in Fasting Plasma glucose (FPG) and Post Prandial blood Glucose (PPG)

    Measured: from week 0 (baseline) to week 24 (end of study)

  5. Evolution of Blood Glucose profiles

    Measured: from week 0 (baseline) to week 24 (end of study)

  6. Incidence of symptomatic hypoglycemia

    Measured: from week 0 (baseline) to week 24 (end of study)

  7. Incidence of nocturnal hypoglycemia

    Measured: from week 0 (baseline) to week 24 (end of study)

  8. Incidence of asymptomatic hypoglycemia

    Measured: from week 0 (baseline) to week 24 (end of study)

  9. Mean change in body weight in patients

    Measured: from week 0 (baseline) to week 24 (end of study)

  10. Mean insulin dose

    Measured: from week 0 (baseline) to week 24 (end of study)

  11. PROMs (patient reported outcome measures) scores from the DTSQs/c (diabetes treatment satisfaction questionnaire status) and EQ-5D (European quality of life - 5 dimensions)

    Measured: from week 0 (baseline) to week 24 (end of study)

Timeline

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

  1. First posted26 Jul 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionJun 2012
  4. Study completionJun 2012

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
555 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01169818
Sponsor's protocol ID
LANTU_R_04889
Other IDs
U1111-1116-2247
Acronym
ATLAS
Status last verified
Jul 2013
First submitted
22 Jul 2010
Last updated
8 Jul 2013
Results posted
No

Publications

  • ATLAS Study Group. Titration of Insulin Glargine in Patients with Type 2 Diabetes Mellitus in Asia: Physician- Versus Patient-Led? Rationale of the Asian Treat to Target Lantus Study (ATLAS). Diabetes Technol Ther. 2011 Jan;13(1):67-72. doi: 10.1089/dia.2010.0170.

    PubMed 21175274

  • Garg SK, Admane K, Freemantle N, Odawara M, Pan CY, Misra A, Jarek-Martynowa IR, Abbas-Raza S, Mirasol RC, Perfetti R. Patient-led versus physician-led titration of insulin glargine in patients with uncontrolled type 2 diabetes: a randomized multinational ATLAS study. Endocr Pract. 2015 Feb;21(2):143-57. doi: 10.4158/EP14079.OR.

    PubMed 25297660

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Insulin Glargine in people with Diabetes Mellitus, Type 2, run by Sanofi at 6 sites in 6 countries.

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 27 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 8 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China, India, Japan, Pakistan, Philippines and 1 more country. 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?

Change (decrease) in mean hemoglobin glycosylated (HbA1c) level (time frame: from week 0 (baseline) to week 24 (end of study)). 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 NCT01169818, which also lists 2 linked publications.

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 8 Jul 2013.

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