A Comparison Study of Basal Bolus Therapies Together With Lispro Insulin in Type 2 Diabetes Patients

This study has been completed.

Study NCT00666718 Information provided by Eli Lilly and Company

First Received on April 23, 2008. Last Updated on May 11, 2011 History of Changes

Results First Received: February 18, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Diabetes Mellitus, Type 2
Interventions:	Drug: Insulin Glargine Drug: Insulin Lispro Protamine Suspension (ILPS) Drug: Insulin Lispro

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Glargine	Glargine plus Insulin Lispro (2-3 injections) plus metformin
ILPS	Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin

Participant Flow: Overall Study

	Glargine	ILPS
STARTED	187	187
COMPLETED	175	169
NOT COMPLETED	12	18
Adverse Event	0	1
Death	1	0
Lost to Follow-up	1	0
Entry Criteria Not Met	2	0
Protocol Violation	1	3
Withdrawal by Subject	7	12
Physician Decision	0	2

Baseline Characteristics

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Reporting Groups

	Description
Glargine	Glargine plus Insulin Lispro (2-3 injections) plus metformin
ILPS	Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin

Baseline Measures

	Glargine	ILPS	Total
Number of Participants [units: participants]	187	187	374
Age [units: years] Mean ± Standard Deviation	60.3 ± 8.07	59.3 ± 8.36	59.8 ± 8.22
Gender [units: participants]
Female	101	111	212
Male	86	76	162
Race/Ethnicity, Customized [units: Participants]
Caucasian	186	186	372
African	0	1	1
Hispanic	1	0	1
Region of Enrollment [units: participants]
Belgium	5	2	7
Czech Republic	42	35	77
Germany	22	20	42
United Kingdom	10	2	12
Greece	12	15	27
Italy	19	26	45
Poland	32	43	75
Romania	15	25	40
Slovakia	22	12	34
Turkey	8	7	15
Number of Insulin Injections/Inhalations Per Day ^[1] [units: Participants]
1 Insulin Injection/Inhalation per day	104	106	210
2 Insulin Injections/Inhalations per day	31	34	65
3 Insulin Injections/Inhalations per day	30	32	62
4 Insulin Injections/Inhalations per day	16	14	30
>=5 Insulin Injections/Inhalations per day	6	0	6
Missing Data	0	1	1
Body Weight [units: kilograms (kg)] Mean ± Standard Deviation	93.53 ± 17.168	90.60 ± 17.075	92.06 ± 17.161
Body Mass Index (BMI) ^[2] [units: kilograms per square meter (kg/m^2)] Mean ± Standard Deviation	33.27 ± 5.040	33.00 ± 5.004	33.13 ± 5.017
Hemoglobin A1c (HbA1c) [units: Percent of glycosylated hemoglobin] Mean ± Standard Deviation	8.83 ± 0.896	8.82 ± 0.895	8.82 ± 0.894
Duration of Diabetes [units: Years] Mean ± Standard Deviation	12.7 ± 7.04	11.8 ± 6.66	12.3 ± 6.86
Previous Insulin Treatment ^[3] [units: Units (IU)] Mean ± Standard Deviation	36.9 ± 25.65	37.6 ± 25.75	37.3 ± 25.67

[1]	The number of insulin injections/inhalations is calculated as the sum of injections per day from the most recently applied insulins before randomization.
[2]	Body mass index is an estimate of body fat based on body weight divided by height squared.
[3]	The dose is calculated as the total dose from the most recently applied previous insulins before randomization.

Outcome Measures

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1. Primary:

Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24 [ Time Frame: Baseline, Week 24 ]

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2. Secondary:

Change From Baseline in HbA1c at Week 12 and Week 24 [ Time Frame: Baseline, Week 12, Week 24 ]

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3. Secondary:

Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint [ Time Frame: Week 24 ]

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4. Secondary:

7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint [ Time Frame: 24 weeks ]

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5. Secondary:

Glycemic Variability at Endpoint [ Time Frame: Week 24 ]

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6. Secondary:

Rate Of All Self-reported Hypoglycemic Episodes [ Time Frame: Baseline through Week 24 ]

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7. Secondary:

Percentage of Participants With Self-Reported Hypoglycemic Episodes [ Time Frame: Baseline through Week 24 ]

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8. Secondary:

Number of Participants With Adverse Events (AE) [ Time Frame: Baseline through Week 24 ]

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9. Secondary:

Change in Body Weight From Baseline to Week 24 [ Time Frame: Baseline, Week 24 ]

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10. Secondary:

Total Daily Insulin Dose at Endpoint [ Time Frame: Week 24 ]

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11. Secondary:

Number of Injections of Insulin at Week 24 [ Time Frame: Week 24 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00666718 History of Changes
Other Study ID Numbers:	12047, F3Z-EW-IOPJ
Study First Received:	April 23, 2008
Results First Received:	February 18, 2011
Last Updated:	May 11, 2011
Health Authority:	Greece: Ethics Committee; Greece: National Organization of Medicines; Turkey: Ministry of Health; Czech Republic: Ethics Committee; Czech Republic: State Institute for Drug Control; Belgium: Federal Agency for Medicinal Products and Health Products; Belgium: Institutional Review Board; Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committee; Romania: National Medicines Agency; Poland: Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Italy: Ethics Committee; Italy: Ministry of Health