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OpenTrials
Completed

NCT Number: NCT00941369

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

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

Berlin, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin Glargine (HOE901)/NPH Insulin

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 17, 2009
Registry last updated
Nov 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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