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

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ClinicalTrials.gov Identifier: NCT00941369
Recruitment Status : Completed
First Posted : July 17, 2009
Last Update Posted : November 22, 2012
Sponsor:
Information provided by (Responsible Party):
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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 345 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : June 2009
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. Lipid assessment [ Time Frame: At 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint) ]
  4. Hypoglycemia assessment [ Time Frame: Throughout the study from starting until the week 48 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00941369


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00941369     History of Changes
Other Study ID Numbers: LANTU_L_04079
2009-019013-59(EudraCT)
First Posted: July 17, 2009    Key Record Dates
Last Update Posted: November 22, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Isophane insulin, beef
Insulin
Insulin Glargine
Insulin, Isophane
Isophane Insulin, Human
Hypoglycemic Agents
Physiological Effects of Drugs