MedDataX Logo

Lispro Mix 25 vs. Glargine in Type 2 Diabetics

NCT ID: NCT00551356

Last Updated: 2007-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2003-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The objective of this study is to investigate which type of insulin regimen is the best way to achieve best glycemic control in early type 2 diabetes. Patients with diabetes mellitus type 2 with a duration of diabetes between 1 and 10 years without previous insulin therapy will be randomized on insulin lispro mix 25 or insulin glargine therapy. Glycemic control will be compared by the between treatment difference in fasting plasma glucose and 2h postprandial blood glucose excursions (preprandial -postprandial excursions) after breakfast.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus Type 2

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Diabetes Diabetic Insulin Humalog Lantus Glargine Lispro

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

2

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

Group Type ACTIVE_COMPARATOR

Glargine

Intervention Type DRUG

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

1

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

Group Type ACTIVE_COMPARATOR

Insulin lispro mix 25

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Insulin lispro mix 25

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

Intervention Type DRUG

Glargine

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Humalog Mix25 Lantus

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Mexico

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

F3Z-ME-IOOL

Identifier Type: -

Identifier Source: secondary_id

7354

Identifier Type: -

Identifier Source: org_study_id