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

NCT00941369 | Completed Phase 4

• 2 other identifiers: LANTU_L_040792009-019013-59(EudraCT)
• Study Type: interventional
• Target: 345
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Health Assessment, Patient treatment satisfaction and Quality-of-Life

  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 (4)

• Glycaemic parameters assessment

  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

  At baseline (visit 2: randomization), 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint)

• Lipid assessment

  At 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint)

• Hypoglycemia assessment

  Throughout the study from starting until the week 48

Study Arms (2)

1

EXPERIMENTAL

Insulin glargine: Lantus® (100 U/ml) in TactiPen® re-usable pen

Drug: Insulin Glargine (HOE901)/NPH Insulin

2

ACTIVE COMPARATOR

Neutral Protamine Hagedorn basal insulin: Insuman® Basal (100 I.U./ml) in TactiPen® re-usable pen

Drug: Insulin Glargine (HOE901)/NPH Insulin

Interventions

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.

1; 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Berlin, Germany

Location

Related Publications (2)

• 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.

  PMID: 33166419 DERIVED

• 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.

  PMID: 26055391 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Heinz Riederer

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2009
• First Posted: July 17, 2009
• Study Start: June 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 22, 2012

Record last verified: 2012-11

Locations

DE (1)