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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00941369
First received: July 16, 2009
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

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

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Insulin Glargine (HOE901)/NPH Insulin
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Health Assessment, Patient treatment satisfaction and Quality-of-Life [ Time Frame: 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glycaemic parameters assessment [ Time Frame: At baseline (visit 2: randomization), 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint) ] [ Designated as safety issue: No ]
  • Anteropometric data (Weight, waist circumference) assessment [ Time Frame: At baseline (visit 2: randomization), 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint) ] [ Designated as safety issue: No ]
  • Lipid assessment [ Time Frame: At 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint) ] [ Designated as safety issue: No ]
  • Hypoglycemia assessment [ Time Frame: Throughout the study from starting until the week 48 ] [ Designated as safety issue: No ]

Enrollment: 345
Study Start Date: June 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Insulin glargine: Lantus® (100 U/ml) in TactiPen® re-usable pen
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.

Active Comparator: 2
Neutral Protamine Hagedorn basal insulin: Insuman® Basal (100 I.U./ml) in TactiPen® re-usable pen
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.


  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941369

Locations
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Heinz Riederer Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00941369     History of Changes
Other Study ID Numbers: LANTU_L_04079, 2009-019013-59(EudraCT)
Study First Received: July 16, 2009
Last Updated: November 21, 2012
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on April 23, 2014