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

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

Study Description

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 Design

• 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

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• 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.

Contacts and Locations

Locations

Germany

Sanofi-Aventis Administrative Office

Berlin, Germany

Sponsors and Collaborators

Sanofi

Investigators

• Study Director: Heinz Riederer; Sanofi

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.

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.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT00941369
• Other Study ID Numbers: LANTU_L_04079; 2009-019013-59(EudraCT)
• First Posted: July 17, 2009
• 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; Insulin Glargine; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef; Hypoglycemic Agents; Physiological Effects of Drugs