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

Sanofi

Status and phase

Completed

Phase 4

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Insulin Glargine (HOE901)/NPH Insulin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00941369

2009-019013-59(EudraCT)

LANTU_L_04079

Details and patient eligibility

About

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

Enrollment

345 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.