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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

Tracking Information
First Submitted Date  ICMJE July 16, 2009
First Posted Date  ICMJE July 17, 2009
Last Update Posted Date November 22, 2012
Study Start Date  ICMJE June 2009
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2009)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00941369 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2009)
  • 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) ]
  • 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) ]
  • Lipid assessment [ Time Frame: At 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint) ]
  • Hypoglycemia assessment [ Time Frame: Throughout the study from starting until the week 48 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Health Assessment, Patient Treatment Satisfaction and Quality-of-Life in Insulin-Naive Type 2 Diabetes Patients
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE 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.

Study Arms  ICMJE
  • Experimental: 1
    Insulin glargine: Lantus® (100 U/ml) in TactiPen® re-usable pen
    Intervention: Drug: Insulin Glargine (HOE901)/NPH Insulin
  • Active Comparator: 2
    Neutral Protamine Hagedorn basal insulin: Insuman® Basal (100 I.U./ml) in TactiPen® re-usable pen
    Intervention: Drug: Insulin Glargine (HOE901)/NPH Insulin
Publications * Hermanns N, Kulzer B, Kohlmann T, Jacob S, Landgraf W, Theobald K, Haak T. Treatment satisfaction and quality-of-life between type 2 diabetes patients initiating long- vs. intermediate-acting basal insulin therapy in combination with oral hypoglycemic agents--a randomized, prospective, crossover, open clinical trial. Health Qual Life Outcomes. 2015 Jun 9;13:77. doi: 10.1186/s12955-015-0279-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 21, 2012)
345
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2009)
332
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00941369
Other Study ID Numbers  ICMJE LANTU_L_04079
2009-019013-59(EudraCT)
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Heinz Riederer Sanofi
PRS Account Sanofi
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP