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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Health Assessment, Patient Treatment Satisfaction and Quality-of-Life in Insulin-naive Type 2 Diabetes Patients Uncontrolled on Oral Hypoglycemic Agent Treatment Initiating Basal Insulin Therapy With Either Insulin Glargine or NPH Insulin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00941369
• Other study ID #: LANTU_L_04079
• Secondary ID: 2009-019013-59(E
• Status: Completed
• Phase: Phase 4
• First received: July 16, 2009
• Last updated: November 21, 2012
• Start date: June 2009
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria:

• Patients with type 2 diabetes mellitus (no history of ketoacidosis) according to ADA criteria.

• Treatment with a combination of maximum 2 substance classes on a stable dosage during the last 3 months: metformin and/or sulfonylurea.

• No pre-treatment with any insulin in the last 3 months before the study.

• Glycated Haemoglobin A1c (HbA1c) value between > or = 7.0 and > or = 9.5%

• Fasting Blood Glucose (FBG) > or = 120 mg/dl (6.7 mmol/l).

• Body mass index < 40 kg/m.

• Ability to read and understand German language.

• Ability and willingness to follow a tight antidiabetic therapy and to perform blood glucose self monitoring on a regular basis.

• Women of childbearing potential who will take adequate contraceptive protection.

Exclusion criteria:

• Patients with type 1 diabetes mellitus.

• Any history of ketoacidosis.

• Pregnancy.

• Prior treatment with insulin.

• Treatment with more than two oral agents within the last 3 months or continuous treatment with thiazolidinediones, GLP-1 receptor agonists or with Dipeptidyl-Peptidase IV (DPP-IV) inhibitors.

• History of drug or alcohol abuse.

• Diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) in the last 3 months prior to study entry or which may require surgical treatment within 3 months of study entry.

• Following pancreatectomy.

• Impaired hepatic function.

• Impaired renal function.

• Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study.

• Evidence of an uncooperative attitude, including poor compliance to any (antidiabetic) treatment.

• Inability to attend follow-up visits.

• Current treatment because of a mental disorder according to ICD 10(F 5 Diagnoses).

• Patients that are in a relationship of dependance with the investigator(s) and/or the sponsor.

• Systemic corticoids > 7,5 mg prednisolon equivalent or <or=7,5 mg prednisolon equivalent for less than 2 months.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin Glargine (HOE901)/NPH Insulin
Arm 1: Subcutaneous injection of Insulin Glargine with the TactiPen® injector pen once daily at any time, but each day at the same time Arm 2: Subcutaneous injection of Protamine Hagedorn basal insulin with the TactiPen® injector pen once or twice daily at the discretion of the treating physician The starting dose is 10 I.U. (NPH basal insulin) resp. 10 U (insulin glargine) per day. The dose adjustments will be based on the results of self-monitoring.

Locations

Country	Name	City	State
Germany	Sanofi-Aventis Administrative Office	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Glycaemic parameters assessment		At baseline (visit 2: randomization), 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint)	No
Secondary	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)	No
Secondary	Lipid assessment		At 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint)	No
Secondary	Hypoglycemia assessment		Throughout the study from starting until the week 48	No