NCT01169818

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
555

participants targeted

Target at P75+ for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Aug 2010

Typical duration for phase_4 diabetes-mellitus-type-2

Geographic Reach
6 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2010

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 8, 2013

Status Verified

July 1, 2013

Enrollment Period

1.8 years

First QC Date

July 22, 2010

Last Update Submit

July 5, 2013

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change (decrease) in mean hemoglobin glycosylated (HbA1c) level

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

Secondary Outcomes (11)

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

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

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

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

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

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

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

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

  • Evolution of Blood Glucose profiles

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

  • +6 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Initiation on a fixed dose of insulin glargine, then subjects will self-adjusted their basal insulin dose every 3 days

Drug: Insulin Glargine

Usual standard of care group

ACTIVE COMPARATOR

Initiation on a fixed dose of insulin glargine, then basal insulin dose is adjusted at each visit by a physician

Drug: Insulin Glargine

Interventions

Insulin GlargineDRUG

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

Also known as: Solostar
Intervention groupUsual standard of care group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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,
  • 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,
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Administrative office

Shanghai, China

Location

Administrative office

Mumbai, India

Location

Administrative office

Tokyo, Japan

Location

Administrative office

Karachi, Pakistan

Location

Administrative office

Makati City, Philippines

Location

Administrative office

Moscow, Russia

Location

Related Publications (2)

  • 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.

    PMID: 21175274BACKGROUND

  • 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.

    PMID: 25297660DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2010

First Posted

July 26, 2010

Study Start

August 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 8, 2013

Record last verified: 2013-07

Locations

RU(1)CN(1)JP(1)PA(1)IN(1)PH(1)