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Comparison of Two Basal Insulin Therapies for Patients With Type 1 Diabetes

NCT ID: NCT00487240

Last Updated: 2010-11-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

387 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-08-31

Brief Summary

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The purpose of this study is to examine the efficacy and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin combined with mealtime insulin therapy in patients with type 1 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.

Detailed Description

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Phase 3b, randomized, multicenter, multinational, open-label, two-arm, active control, parallel study to determine safety, efficacy, and noninferiority of basal analog insulin lispro protamine suspension (ILPS, also referred to as NPL \[neutral protamine Hagedorn\]), injected two times a day, compared with basal analog insulin detemir, injected two times a day, as measured by change in hemoglobin A1c (HbA1c) from baseline (Visit 2) to 32 weeks in adult patients with type 1 diabetes when used in combination with bolus insulin lispro, injected three times a day.

Conditions

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Diabetes Mellitus, Type 1

Keywords

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diabetes type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Insulin Lispro Protamine Suspension

Insulin Lispro Protamine Suspension twice daily

Group Type EXPERIMENTAL

Insulin Lispro Protamine Suspension

Intervention Type DRUG

Patient specific dose, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks.

Detemir

Insulin Levemir (detemir) subcutaneous (SC) twice daily.

Group Type ACTIVE_COMPARATOR

Insulin Levemir

Intervention Type DRUG

Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks

Interventions

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Insulin Lispro Protamine Suspension

Patient specific dose, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks.

Intervention Type DRUG

Insulin Levemir

Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks

Intervention Type DRUG

Other Intervention Names

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ILPS NPL Humalog LY275585

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of type 1 diabetes for one year or more
* Age 18 years or older
* Body mass index (BMI) less than or equal to 35 kilograms per square meter (kg/m2)
* Have a hemoglobin A1c (HbA1c) 1.2 to 2.0 times the upper limit of the normal (ULN) reference range within 30 days prior to Visit 1 or collected and analyzed at a local laboratory at Visit 1
* As determined by the investigator, are capable and willing to do the following:

* perform self monitoring of blood glucose (SMBG),
* complete patient diaries as required for this protocol,
* use the insulin injection device(s) according to the instructions provided,
* are receptive to diabetes education,
* comply with the required study visits.

Exclusion Criteria

* Have taken any oral antihyperglycemic medications (OAMs) within 3 months prior to Visit 1.
* Have had more than one episode of severe hypoglycemia, as defined in the Abbreviations and Definitions section of the protocol, within 6 months prior to entry into the study
* Are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable or women who are breastfeeding
* Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, intraocular, and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding Visit 1.
* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Eli Lilly

Principal Investigators

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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

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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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Idaho Falls, Idaho, United States

Site Status

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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Springfield, Illinois, United States

Site Status

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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Topeka, Kansas, United States

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San Antonio, Texas, United States

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Buenos Aires, , Argentina

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La Plata, , Argentina

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Wollongong, New South Wales, Australia

Site Status

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Box Hill, Victoria, Australia

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Fortaleza, , Brazil

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São Paulo, , Brazil

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Athens, , Greece

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Thessaloniki, , Greece

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Budapest, , Hungary

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Mosonmagyaróvár, , Hungary

Site Status

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Pécs, , Hungary

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Szentes, , Hungary

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Zalaegerszeg, , Hungary

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Guadalajara, , Mexico

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Pachuca, , Mexico

Site Status

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Puebla City, , Mexico

Site Status

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Baia Mare, , Romania

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Brasov, , Romania

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Bucharest, , Romania

Site Status

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Iași, , Romania

Site Status

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Arkhangelsk, , Russia

Site Status

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Moscow, , Russia

Site Status

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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Rostov-on-Don, , Russia

Site Status

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Saint Petersburg, , Russia

Site Status

Countries

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United States Argentina Australia Brazil Greece Hungary Mexico Romania Russia

References

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Chacra AR, Kipnes M, Ilag LL, Sarwat S, Giaconia J, Chan J; COMPLETE T1D investigators. Comparison of insulin lispro protamine suspension and insulin detemir in basal-bolus therapy in patients with Type 1 diabetes. Diabet Med. 2010 May;27(5):563-9. doi: 10.1111/j.1464-5491.2010.02986.x.

Reference Type RESULT
PMID: 20536953 (View on PubMed)

Other Identifiers

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F3Z-MC-IOOZ

Identifier Type: OTHER

Identifier Source: secondary_id

10937

Identifier Type: -

Identifier Source: org_study_id