Back to resultsEvaluation of the Effectiveness and Safety of Physician Versus Patient-led of Insulin Glargine Initiation and Titration in Type 2 Diabetes Mellitus (ATLAS)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Insulin Glargine
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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,
- 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.
Sites / Locations
- Administrative office
- Administrative office
- Administrative office
- Administrative office
- Administrative office
- Administrative office
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Usual standard of care group
Arm Description
Initiation on a fixed dose of insulin glargine, then subjects will self-adjusted their basal insulin dose every 3 days
Initiation on a fixed dose of insulin glargine, then basal insulin dose is adjusted at each visit by a physician
Outcomes
Primary Outcome Measures
Change (decrease) in mean hemoglobin glycosylated (HbA1c) level
Secondary Outcome Measures
Percentage of patients achieving HbA1c levels < 7.0% without experiencing severe hypoglycemia
Percentage of patients achieving target HbA1c levels (< 7.0% and <6.5%)
Number of patients having a drop of 1% in HbA1c levels and/or a drop of at least 0.5%.
Mean change in Fasting Plasma glucose (FPG) and Post Prandial blood Glucose (PPG)
Evolution of Blood Glucose profiles
Incidence of symptomatic hypoglycemia
Incidence of nocturnal hypoglycemia
Incidence of asymptomatic hypoglycemia
Mean change in body weight in patients
Mean insulin dose
PROMs (patient reported outcome measures) scores from the DTSQs/c (diabetes treatment satisfaction questionnaire status) and EQ-5D (European quality of life - 5 dimensions)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01169818
Brief Title
Evaluation of the Effectiveness and Safety of Physician Versus Patient-led of Insulin Glargine Initiation and Titration in Type 2 Diabetes Mellitus
Acronym
ATLAS
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
555 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Initiation on a fixed dose of insulin glargine, then subjects will self-adjusted their basal insulin dose every 3 days
Arm Title
Usual standard of care group
Arm Type
Active Comparator
Arm Description
Initiation on a fixed dose of insulin glargine, then basal insulin dose is adjusted at each visit by a physician
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine
Other Intervention Name(s)
Solostar
Intervention Description
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
Primary Outcome Measure Information:
Title
Change (decrease) in mean hemoglobin glycosylated (HbA1c) level
Time Frame
from week 0 (baseline) to week 24 (end of study)
Secondary Outcome Measure Information:
Title
Percentage of patients achieving HbA1c levels < 7.0% without experiencing severe hypoglycemia
Time Frame
from week 0 (baseline) to week 24 (end of study)
Title
Percentage of patients achieving target HbA1c levels (< 7.0% and <6.5%)
Time Frame
from week 0 (baseline) to week 24 (end of study)
Title
Number of patients having a drop of 1% in HbA1c levels and/or a drop of at least 0.5%.
Time Frame
from week 0 (baseline) to week 24 (end of study)
Title
Mean change in Fasting Plasma glucose (FPG) and Post Prandial blood Glucose (PPG)
Time Frame
from week 0 (baseline) to week 24 (end of study)
Title
Evolution of Blood Glucose profiles
Time Frame
from week 0 (baseline) to week 24 (end of study)
Title
Incidence of symptomatic hypoglycemia
Time Frame
from week 0 (baseline) to week 24 (end of study)
Title
Incidence of nocturnal hypoglycemia
Time Frame
from week 0 (baseline) to week 24 (end of study)
Title
Incidence of asymptomatic hypoglycemia
Time Frame
from week 0 (baseline) to week 24 (end of study)
Title
Mean change in body weight in patients
Time Frame
from week 0 (baseline) to week 24 (end of study)
Title
Mean insulin dose
Time Frame
from week 0 (baseline) to week 24 (end of study)
Title
PROMs (patient reported outcome measures) scores from the DTSQs/c (diabetes treatment satisfaction questionnaire status) and EQ-5D (European quality of life - 5 dimensions)
Time Frame
from week 0 (baseline) to week 24 (end of study)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
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
Exclusion criteria:
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,
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Administrative office
City
Shanghai
Country
China
Facility Name
Administrative office
City
Mumbai
Country
India
Facility Name
Administrative office
City
Tokyo
Country
Japan
Facility Name
Administrative office
City
Karachi
Country
Pakistan
Facility Name
Administrative office
City
Makati City
Country
Philippines
Facility Name
Administrative office
City
Moscow
Country
Russian Federation
12. IPD Sharing Statement
Citations:
PubMed Identifier
21175274
Citation
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.
Results Reference
background
PubMed Identifier
25297660
Citation
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.
Results Reference
derived
Learn more about this trial
Evaluation of the Effectiveness and Safety of Physician Versus Patient-led of Insulin Glargine Initiation and Titration in Type 2 Diabetes Mellitus
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