Insulin Glargine Plus Insulin Glulisine Multiple Daily Injections (MDI) Versus Premix Insulin Treatment in Subjects With Diabetes Mellitus (Type 1 or Type 2)

June 2, 2009 updated by: Sanofi

Insulin Glargine Plus Insulin Glulisine MDI Versus Premix Insulin Treatment in Subjects With Diabetes Mellitus (Type 1 or Type 2) Evaluating Differences in Patient Reported Outcomes

The purpose of this study is to test for superiority in improvements from baseline in patient reported outcomes in subjects with type 1 or type 2 diabetes when treated with insulin glargine plus rapid acting insulin glulisine MDI versus treatment with premix insulin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

582

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Advanced Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent in writing at enrollment
  • Subjects with type 1 or type 2 diabetes mellitus for at least six months
  • Male or female 21 - 70 years of age
  • Employed, unpaid work or active lifestyle
  • Screening hemoglobin A1c (HbA1c) level of ≥ 7.0 and ≤ 9.0 %
  • Current (last 3 months) daily use of premix insulin 75/25, 70/30, or isophane insulin (NPH) or Lantus with short acting insulin, consisting of 2 or more injections per day with or without concomitant therapy consisting of metformin, thiazolidinedione, and/or alpha-glucosidase inhibitors.
  • Willing and able to inject insulin glargine and multi-day dosing of insulin glulisine.
  • Willing and able to perform self-monitoring of blood glucose (SMBG) four times a day and continuous glucose monitoring (CGMS) for 48 hours at three time periods during the study
  • Willing and able to use adequate contraception if of child bearing age
  • Able to read and understand English (at the sixth grade level) and comply with the study protocol

Exclusion Criteria:

  • Cardiac status New York Heart Association (NYHA) III-IV
  • Serum creatinine ≥ 1.5 mg/dl for males, or ≥ 1.4 mg/dl for females.
  • Clinical evidence of active liver disease or serum ALT or AST > 2.5 times the upper limit of normal range.
  • Subjects currently using an insulin pump
  • Subjects currently taking sulfonylureas, repaglinide, nateglinide, symlin (pramlintide acetate) or byetta (exenatide).
  • Planned pregnancy in next 6 months or pregnant or lactating females
  • Diagnosis of dementia or mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
  • Unable to obtain complete CGMS data prior to baseline, visit 2 (week 0)
  • Hypersensitivity to insulin glargine or insulin glulisine or premix insulin or any of their components
  • Any disease or condition (including abuse of illicit drugs, prescription medicines or alcohol) that in the opinion of the investigator or sponsor may interfere with the study compliance and completion of the study.
  • Treatment with intermittent doses of systemic steroids or intermittent large doses of inhaled steroids for the past one year (treatment with fixed doses for the past 6 months is acceptable providing there is no plan to change the dosage regimen)
  • Treatment with any investigational product in the last 3 months before study entry
  • Stroke, myocardial infarction (MI), coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA), or unstable angina pectoris within the last 12 months
  • Current malignancy, any previous breast cancer, any previous malignant melanoma or any cancer within the past 5 years (except adequately treated basal cell skin cancer)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Sequence 1 (Lantus + Apidra first, then Premix): Subjects randomized to this sequence will receive ApidraTM administered three times per day 0-15 minutes before main meals using a fixed bolus regimen following titration based on preprandial blood glucose values; as well as Lantus qd for 12 weeks. After the first 12 weeks, subjects will cross over to the premix insulin for a further treatment of 12 weeks.
Drug: insulin glargine
Sequence 1 (Lantus + Apidra first, then Premix): Subjects randomized to this sequence will receive ApidraTM administered three times per day 0-15 minutes before main meals using a fixed bolus regimen following titration based on preprandial blood glucose values; as well as Lantus qd for 12 weeks. After the first 12 weeks, subjects will cross over to the premix insulin for a further treatment of 12 weeks.
Experimental: 2
Sequence 2 (Premix first, then Lantus + Apidra): Subjects randomized to this sequence will receive premix insulin (either Humalog Mix 75/25 or Novolog Mix 70/30, depending on which insulin they were taking at entry into the study) once or twice per day for 12 weeks. After the first 12 weeks, subjects will cross over to the Lantus plus Apidra sequence for a further treatment of 12 weeks.
Drug: insulin glulisine
Sequence 2 (Premix first, then Lantus + Apidra): Subjects randomized to this sequence will receive premix insulin (either Humalog Mix 75/25 or Novolog Mix 70/30, depending on which insulin they were taking at entry into the study) once or twice per day for 12 weeks. After the first 12 weeks, subjects will cross over to the Lantus plus Apidra sequence for a further treatment of 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare improvements from baseline in patient reported outcomes (quality of life, treatment satisfaction) when aggressively treated with insulin glargine plus rapid acting insulin glulisine vs treatment with Premix insulin
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
change in A1c (baseline to week 24), reported hypo events (throughout the trials), correlation between patient reported outcomes and glucose variability as measured by CGMS (baseline, week 8 and week 20).
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Lisa Jean-Louis, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

August 23, 2005

First Submitted That Met QC Criteria

August 25, 2005

First Posted (Estimate)

August 26, 2005

Study Record Updates

Last Update Posted (Estimate)

June 4, 2009

Last Update Submitted That Met QC Criteria

June 2, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMR1964A_3508

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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