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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Insulin Glargine

• Registration Number: NCT01169818
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-22
• Study First Submitted QC: 2010-07-23
• Study First Posted: 2010-07-26
• Study Start: 2010-08
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-05
• Last Update Posted: 2013-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 555

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual standard of care group	Insulin Glargine	Initiation on a fixed dose of insulin glargine, then basal insulin dose is adjusted at each visit by a physician
Intervention group	Insulin Glargine	Initiation on a fixed dose of insulin glargine, then subjects will self-adjusted their basal insulin dose every 3 days

Primary Outcome Measures

Name	Time	Method
Change (decrease) in mean hemoglobin glycosylated (HbA1c) level	from week 0 (baseline) to week 24 (end of study)

Secondary Outcome Measures

Name	Time	Method
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)
Incidence of symptomatic hypoglycemia	from week 0 (baseline) to week 24 (end of study)
Incidence of nocturnal hypoglycemia	from week 0 (baseline) to week 24 (end of study)
Incidence of asymptomatic hypoglycemia	from week 0 (baseline) to week 24 (end of study)
Mean change in body weight in patients	from week 0 (baseline) to week 24 (end of study)
Mean insulin dose	from week 0 (baseline) to week 24 (end of study)
PROMs (patient reported outcome measures) scores from the DTSQs/c (diabetes treatment satisfaction questionnaire status) and EQ-5D (European quality of life - 5 dimensions)	from week 0 (baseline) to week 24 (end of study)

Trial Locations

Locations (1)

Administrative office; 🇷🇺 Moscow, Russian Federation