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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01169818
First received: July 22, 2010
Last updated: July 5, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Insulin Glargine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change (decrease) in mean hemoglobin glycosylated (HbA1c) level [ Time Frame: from week 0 (baseline) to week 24 (end of study) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients achieving HbA1c levels < 7.0% without experiencing severe hypoglycemia [ Time Frame: from week 0 (baseline) to week 24 (end of study) ] [ Designated as safety issue: No ]
  • Percentage of patients achieving target HbA1c levels (< 7.0% and <6.5%) [ Time Frame: from week 0 (baseline) to week 24 (end of study) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Evolution of Blood Glucose profiles [ Time Frame: from week 0 (baseline) to week 24 (end of study) ] [ Designated as safety issue: No ]
  • Incidence of symptomatic hypoglycemia [ Time Frame: from week 0 (baseline) to week 24 (end of study) ] [ Designated as safety issue: Yes ]
  • Incidence of nocturnal hypoglycemia [ Time Frame: from week 0 (baseline) to week 24 (end of study) ] [ Designated as safety issue: Yes ]
  • Incidence of asymptomatic hypoglycemia [ Time Frame: from week 0 (baseline) to week 24 (end of study) ] [ Designated as safety issue: Yes ]
  • Mean change in body weight in patients [ Time Frame: from week 0 (baseline) to week 24 (end of study) ] [ Designated as safety issue: No ]
  • Mean insulin dose [ Time Frame: from week 0 (baseline) to week 24 (end of study) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 555
Study Start Date: August 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention group
Initiation on a fixed dose of insulin glargine, then subjects will self-adjusted their basal insulin dose every 3 days
Drug: Insulin Glargine

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

Other Name: Solostar
Active Comparator: Usual standard of care group
Initiation on a fixed dose of insulin glargine, then basal insulin dose is adjusted at each visit by a physician
Drug: Insulin Glargine

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

Other Name: Solostar

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

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

Exclusion criteria:

  1. Diabetes other than type 2 diabetes (e.g. secondary to pancreatic disorders, drug or chemical agent intake),
  2. Current or previous use of insulin (except for previous treatment of gestational diabetes or brief treatment with insulin for < 1 week),
  3. Current treatment with thiazolidinediones,
  4. Current or previous use (within the last 3 months) of GLP-1 receptor agonists or GLP-1 analogues,
  5. Current or previous (within the last 3 months) use of any treatment for weight lost,
  6. Active proliferative diabetic retinopathy,
  7. Patient without any history of eye examination in the past 6 months,
  8. Treatment with systemic corticosteroids in the 3 months prior to study entry,
  9. Currently receiving treatment with monoamine oxidase inhibitors,
  10. Currently receiving treatment with non-selective -blockers,
  11. Treatment with any investigational product and/or device in the 2 months prior to study entry,
  12. Likelihood of requiring treatment during the study period with drugs not permitted by the clinical trial protocol,
  13. History of ketoacidosis or hyperosmolar hyperglycemic state,
  14. History of stroke, myocardial infarction, angina pectoris, coronary artery bypass graft or percutaneous transluminal coronary angioplasty within the previous 12 months,
  15. History of congestive heart failure,
  16. History of hypoglycemia unawareness,
  17. Unexplained hypoglycemia in the past 6 months,
  18. 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),
  19. Active liver disease (alanine transaminase ALAT greater than two times the upper limit of the reference range, as defined by the local laboratory),
  20. Have any condition (including known substance or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the study protocol,
  21. Had a blood transfusion or severe blood loss within the 3 months before screening, or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia,
  22. Known hypersensitivity / intolerance to insulin glargine or any of its excipients,
  23. History of pancreatitis,
  24. 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),
  25. Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method),
  26. 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01169818

Locations
China
Administrative office
Shanghai, China
India
Administrative office
Mumbai, India
Japan
Administrative office
Tokyo, Japan
Pakistan
Administrative office
Karachi, Pakistan
Philippines
Administrative office
Makati City, Philippines
Russian Federation
Administrative office
Moscow, Russian Federation
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Publications:
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01169818     History of Changes
Other Study ID Numbers: LANTU_R_04889, U1111-1116-2247
Study First Received: July 22, 2010
Last Updated: July 5, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014