NCT00540709

Brief Summary

Whether a once-daily basal injection of insulin glargine with mealtime injections of insulin lispro achieves equivalent glycaemic control (HbA1c) to administration of insulin lispro by continuous subcutaneous insulin infusion in Type 1 diabetic patients.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_4 diabetes-mellitus

Timeline
Completed

Started Nov 2002

Shorter than P25 for phase_4 diabetes-mellitus

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 8, 2007

Completed
Last Updated

February 17, 2012

Status Verified

February 1, 2012

Enrollment Period

10 months

First QC Date

October 5, 2007

Last Update Submit

February 15, 2012

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Primary efficacy data was HbA1c.

    At week 24 (the last day of the treatment period).

Secondary Outcomes (1)

  • Secondary efficacy data included HbA1c.

    At Week 8 and Week 16 after starting study medication and selfmonitored blood glucose (SMBG) measurements.

Interventions

Insulin GlargineDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of type 1 diabetes mellitus for at least one year.
  • Subjects with no previous experience with Continuous Subcutaneous Insulin Infusion (CSII) or insulin glargine,
  • capable of managing a basal-bolus regimen and meeting glycaemic targets in accordance with the protocol.
  • HbA1c \> than or = to 6.5 \< than or = to 9.0% at screening visit with evidence of lack of insulin secretion (e.g. fasting C-peptide concentration is \< 0.1 nmol/l with fasting blood glucose(FBG) \> 126 mg/dl).

You may not qualify if:

  • Previous therapy using insulin glargine or continuous subcutaneous insulin infusion.
  • Lipodystrophy preventing adequate use of CSII.
  • Unwilling or unlikely to be able to use MiniMedr insulin pump with insulin lispro for CSII.
  • Unwilling or unlikely to be able to use an MDI regimen with insulin glargine and insulin lispro in accordance with the protocol (for instance, subjects who routinely use a twice-daily mixed insulin regimen should not be included).
  • History of more than two severe hypoglycaemic episodes in the past 6 months.
  • Acute infection which, in the opinion of the investigator, could lead to increased insulin resistance.
  • Acute or chronic metabolic acidosis.
  • Episode of DKA (diabetic ketoacidosis) within the last three months.
  • Active, uncontrolled, advanced diabetic retinopathy.
  • Impaired hepatic function, as shown by \> 2.5 times the upper limit of normal range for AST.
  • Impaired renal function, as shown by serum creatinine \> 1.5mg/dl.
  • History of gastroparesis. Congestive heart failure requiring ongoing pharmacological treatment.
  • Stroke, myocardial infarction (MI), coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months.
  • Treatment with a non-selective beta blocker.
  • Treatment with inhaled or systemic steroids.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bolli GB, Kerr D, Thomas R, Torlone E, Sola-Gazagnes A, Vitacolonna E, Selam JL, Home PD. Comparison of a multiple daily insulin injection regimen (basal once-daily glargine plus mealtime lispro) and continuous subcutaneous insulin infusion (lispro) in type 1 diabetes: a randomized open parallel multicenter study. Diabetes Care. 2009 Jul;32(7):1170-6. doi: 10.2337/dc08-1874. Epub 2009 Apr 23.

    PMID: 19389820DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 5, 2007

First Posted

October 8, 2007

Study Start

November 1, 2002

Primary Completion

September 1, 2003

Study Completion

September 1, 2003

Last Updated

February 17, 2012

Record last verified: 2012-02