Health Assessment, Patient Treatment Satisfaction and Quality-of-Life in Insulin-Naive Type 2 Diabetes Patients

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Insulin Glargine (HOE901)/NPH Insulin

• Registration Number: NCT00941369
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To investigate the impact of insulin glargine versus Neutral Protamine Hagedorn basal insulin on a composite diabetes related quality of life score (DRQoL).

Secondary Objective:

A comparison of combination therapy with insulin glargine versus Neutral Protamine Hagedorn basal insulin from baseline to endpoint in terms of:

* Glycaemic parameters: 7 blood glucose profiles

* Incidence of confirmed symptomatic hypoglycemia as well as confirmed severe hypoglycemia

* Change in lipid status

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-16
• Study First Submitted QC: 2009-07-16
• Study First Posted: 2009-07-17
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-21
• Last Update Posted: 2012-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 345

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Insulin Glargine (HOE901)/NPH Insulin	Neutral Protamine Hagedorn basal insulin: Insuman® Basal (100 I.U./ml) in TactiPen® re-usable pen
1	Insulin Glargine (HOE901)/NPH Insulin	Insulin glargine: Lantus® (100 U/ml) in TactiPen® re-usable pen

Primary Outcome Measures

Name	Time	Method
Health Assessment, Patient treatment satisfaction and Quality-of-Life	At baseline (visit 2: randomization), at 24 weeks after the randomization (visit 7: cross over visit) and 48 weeks after the randomization (visit 12: endpoint)

Secondary Outcome Measures

Name	Time	Method
Glycaemic parameters assessment	At baseline (visit 2: randomization), 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint)
Anteropometric data (Weight, waist circumference) assessment	At baseline (visit 2: randomization), 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint)
Lipid assessment	At 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint)
Hypoglycemia assessment	Throughout the study from starting until the week 48

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇩🇪 Berlin, Germany