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

Primary Purpose

Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Insulin Lispro Protamine Suspension

Insulin Levemir

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring diabetes, type 1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Insulin Lispro Protamine Suspension

Detemir

Arm Description

Insulin Lispro Protamine Suspension twice daily

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

Outcomes

Primary Outcome Measures

Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint

Secondary Outcome Measures

Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values

The summary statistics represents the mean of all subjects. Change from baseline is calculated for each individual subject for the specific visit and then the "mean change from baseline" is calculated by averaging out for all subjects. [Sum over all (i) {A1c at Week 8 for Subject(i) minus A1c Baseline for Subject (i)}/Total Subjects]. Therefore, for example, the Change from Baseline is not equal to the difference of Mean A1c for Week 8 minus Mean A1c for baseline.

Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5%

7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint

Actual daily mean blood glucose levels at endpoint. The SMBG excursion is the difference between the postprandial and preprandial blood glucose concentration taken at the morning, midday and evening meals.

Glycemic Variability at Endpoint

Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitored blood glucose [SMBG] profiles at endpoint); mean value (M-value), which was the mean of the intra-days self-monitored blood glucose values, and by the mean of daily difference (MODD), which was the mean of the between-days self-monitored blood glucose values.

Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint

Nocturnal: Defined as any hypoglycemic event that occurs between bedtime and waking. Non-Nocturnal: Defined as any hypoglycemic event that occurs between waking and bedtime. Severe: An episode with symptoms consistent with neuroglycopenia in which the patient requires the assistance of another person; associated with either a blood glucose level of <2.8 mmol/L (<50 mg/dL) or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.

1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint

30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint

Change From Baseline in Absolute Body Weight at 32 Week Endpoint

Insulin Dose Per Body Weight (Total and By Component [Basal and Bolus])

Total daily insulin dose adjusted for body weight (U/kg/day) was assessed.

Insulin Dose (Total and By Component [Basal and Bolus])

Total daily insulin dose (U/day) was assessed.

Full Information

NCT ID

NCT00487240

First Posted

June 14, 2007

Last Updated

October 20, 2010

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00487240

Brief Title

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

Acronym

IOOZ

Official Title

Comparison of Two Basal Insulin Analogs (Insulin Lispro Protamine Suspension and Insulin Detemir) in Basal-Bolus Therapy for Patients With Type 1 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

October 2010

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

Keywords

diabetes, type 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

387 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Insulin Lispro Protamine Suspension

Arm Type

Experimental

Arm Description

Insulin Lispro Protamine Suspension twice daily

Arm Title

Detemir

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Insulin Lispro Protamine Suspension

Other Intervention Name(s)

ILPS, NPL, Humalog, LY275585

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Insulin Levemir

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint

Time Frame

baseline and 32 weeks

Secondary Outcome Measure Information:

Title

Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values

Description

Time Frame

Baseline, 8,16, 24, 32 Weeks

Title

Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5%

Time Frame

32 Weeks

Title

7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint

Description

Time Frame

32 Weeks

Title

Glycemic Variability at Endpoint

Description

Time Frame

32 Weeks

Title

Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint

Description

Time Frame

Baseline to 32 Weeks

Title

1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint

Description

Time Frame

baseline to 32 weeks

Title

30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint

Time Frame

baseline to 32 weeks

Title

Change From Baseline in Absolute Body Weight at 32 Week Endpoint

Time Frame

Baseline, 32 Weeks

Title

Insulin Dose Per Body Weight (Total and By Component [Basal and Bolus])

Description

Total daily insulin dose adjusted for body weight (U/kg/day) was assessed.

Time Frame

32 Weeks

Title

Insulin Dose (Total and By Component [Basal and Bolus])

Description

Total daily insulin dose (U/day) was assessed.

Time Frame

32 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62704

Country

United States

Facility Name

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

City

Buenos Aires

ZIP/Postal Code

C1213AAH

Country

Argentina

Facility Name

City

La Plata

ZIP/Postal Code

B1902AWL

Country

Argentina

Facility Name

City

Wollongong

State/Province

New South Wales

Country

Australia

Facility Name

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

City

Fortaleza

ZIP/Postal Code

60120-020

Country

Brazil

Facility Name

City

São Paulo

ZIP/Postal Code

04020041

Country

Brazil

Facility Name

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

City

Thessaloniki

ZIP/Postal Code

56429

Country

Greece

Facility Name

City

Budapest

ZIP/Postal Code

1088

Country

Hungary

Facility Name

City

Mosonmagyarovar

ZIP/Postal Code

9200

Country

Hungary

Facility Name

City

Pecs

ZIP/Postal Code

7623

Country

Hungary

Facility Name

City

Szentes

ZIP/Postal Code

6600

Country

Hungary

Facility Name

City

Zalaegerszeg

ZIP/Postal Code

8900

Country

Hungary

Facility Name

City

Guadalajara

ZIP/Postal Code

44600

Country

Mexico

Facility Name

City

Pachuca

ZIP/Postal Code

42090

Country

Mexico

Facility Name

City

Puebla

ZIP/Postal Code

72160

Country

Mexico

Facility Name

City

Baia Mare

ZIP/Postal Code

430071

Country

Romania

Facility Name

City

Brasov

ZIP/Postal Code

500326

Country

Romania

Facility Name

City

Bucharest

ZIP/Postal Code

70266

Country

Romania

Facility Name

City

Iasi

ZIP/Postal Code

6600

Country

Romania

Facility Name

City

Arkhangelsk

ZIP/Postal Code

163045

Country

Russian Federation

Facility Name

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

City

Rostov-On-Don

ZIP/Postal Code

344022

Country

Russian Federation

Facility Name

City

Saint Petersburg

ZIP/Postal Code

193257

Country

Russian Federation

12. IPD Sharing Statement

Citations:

PubMed Identifier

20536953

Citation

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.

Results Reference

result

Learn more about this trial

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

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