NCT00551356

Brief Summary

In patients with type 2 diabetes who have not been on insulin therapy before the study will achieve better glycemic control by the treatment regiment consisting of two times daily insulin lispro mix 25 than by the treatment regiment with consisting of one time daily injection of insulin glargine. Improved glycemic control will be compared by the fasting plasma glucose and blood glucose excursions 2 hours after breakfast.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at below P25 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Nov 2002

Shorter than P25 for phase_3 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

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
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2007

Completed
Last Updated

October 31, 2007

Status Verified

October 1, 2007

First QC Date

October 29, 2007

Last Update Submit

October 29, 2007

Conditions

Diabetes Mellitus Type 2

Keywords

DiabetesDiabeticInsulinHumalogLantusGlargineLispro

Outcome Measures

Primary Outcomes (1)

  • Change from baseline to endpoint in 2h postprandial blood glucose excursion after breakfast

    16 weeks or end of study.

Secondary Outcomes (7)

  • Hemoglobin A1c measured at endpoint

    16 weeks or end of study.

  • Change of hemoglobin A1c from baseline to endpoint

    16 weeks or end of study.

  • Glycemic control as determined by self-monitored blood glucose concentrations

    16 weeks or end of study.

  • The incidence and rate of self-reported hypoglycemic episodes

    16 weeks or end of study.

  • Body mass index (BMI)

    16 weeks or end of study.

  • +2 more secondary outcomes

Study Arms (2)

2

ACTIVE COMPARATOR

Insulin glargine given SC once-daily in conjunction with oral antidiabetic medications.

Drug: Glargine

1

ACTIVE COMPARATOR

Lispro mix 25 SC twice-daily in conjunction with oral antidiabetic medications.

Drug: Insulin lispro mix 25

Interventions

Insulin lispro mix 25DRUG

Insulin lispro mix 25 given SC twice-daily in conjunction with oral antidiabetic medications.

Also known as: Humalog Mix25
1
GlargineDRUG

Insulin glargine given SC once-daily in conjunction with oral antidiabetic medications.

Also known as: Lantus
2

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females who have type 2 diabetes between 1 and 10 years
  • Have used diet and/or maximum doses of oral antidiabetic agents (combination) for the treatment of their diabetes
  • Have not been on insulin treatment within 3 months before entry into the study
  • Have a hemoglobin A1c in the range of 8.0 to 12.5% according to a local laboratory within 4 weeks prior to or at Visit 1
  • Have a body mass index below 40 kg/m²

You may not qualify if:

  • Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to Visit 1
  • Have a known allergy to insulin
  • Have serum creatinine greater than or equal to 1.5 mg/dl as determined by a local laboratory
  • Have known proliferative retinopathy
  • Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to entering the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Mexico City, Mexico

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusInsulin Resistance

Interventions

insulin lispro, isophane insulin lispro drug combination (25:75)Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 29, 2007

First Posted

October 31, 2007

Study Start

November 1, 2002

Study Completion

July 1, 2003

Last Updated

October 31, 2007

Record last verified: 2007-10

Locations

ME(1)