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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glargine
Insulin
Insulin, Globin Zinc
Insulin, Isophane
Insulin, Long-Acting
Isophane insulin, beef
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014