Insulin Glargine "All to Target" Trial

This study has been completed.

Study NCT00384085 Information provided by Sanofi-Aventis

First Received on October 3, 2006. Last Updated on May 4, 2011 History of Changes

Results First Received: March 31, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Diabetes Mellitus, Type 2
Interventions:	Drug: Insulin Glulisine Drug: Insulin Glargine Drug: Premixed Insulin

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 123 study sites were activated in the United States; 99 sites enrolled and randomized 588 patients from May 2006 to March 2010. 582 patients out of 588 patients were treated. Three sites (which included 26 patients) were found to be non Good Clinical Practices (GCP) compliant.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patient were considered enrolled after informed consent were obtained, and randomized after completion of the 4-week run-in phase and assessment of the randomization criteria.

Reporting Groups

	Description
Lantus/Apidra-3	Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
Lantus/Apidra-1	Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
Novolog Mix 70/30	Premixed insulin (Novolog® Mix 70/30) added to oral agents.

Participant Flow: Overall Study

	Lantus/Apidra-3	Lantus/Apidra-1	Novolog Mix 70/30
STARTED	195 ^[1]	196 ^[1]	197 ^[1]
Intent-To-Treat (ITT)	195	196	197
Treated (Safety Population)	194	194	194
Intent-To-Treat (Excluding nonGCP Sites)	187	186	189
COMPLETED	156 ^[2]	150 ^[2]	141 ^[2]
NOT COMPLETED	39	46	56
Adverse Event	5	5	4
Lack of Efficacy	0	3	2
No longer Requires Study Treatment	1	0	1
Protocol Violation	2	2	2
Lost to Follow-up	9	9	10
Progressive Disease	0	1	0
Withdrawal by Subject	14	19	29
Patient non-compliant	4	4	5
Physician Decision	1	0	0
Loss of site personnel	1	0	1
Sponsor decision	1	2	1
Patient moved	1	0	1
Patient required surgery	0	1	0

[1]	Randomized
[2]	Based on the entire ITT population

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Lantus/Apidra-3	Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
Lantus/Apidra-1	Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
Novolog Mix 70/30	Premixed insulin (Novolog® Mix 70/30) added to oral agents.

Baseline Measures

	Lantus/Apidra-3	Lantus/Apidra-1	Novolog Mix 70/30	Total
Number of Participants [units: participants]	195	196	197	588
Age [units: years] Mean ± Standard Deviation	54.9 ± 10.54	53.7 ± 9.11	53.7 ± 10.65	54.1 ± 10.12
Gender [units: participants]
Female	78	88	86	252
Male	117	108	111	336
Region of Enrollment [units: participants]
United States	195	196	197	588
Weight [units: kilograms (kg)] Mean ± Standard Deviation	95.2 ± 19.21	97.2 ± 20.88	97.9 ± 20.49	96.8 ± 20.21
Body Mass Index (BMI) [units: Kilogram/m^2] Mean ± Standard Deviation	32.7 ± 5.79	33.4 ± 6.00	33.4 ± 5.62	33.1 ± 5.80
Duration of diabetes at study entry [units: years] Mean ± Standard Deviation	9.4 ± 6.80	9.1 ± 5.70	9.5 ± 5.87	9.3 ± 6.13
Age at onset of diabetes [units: years] Mean ± Standard Deviation	46.0 ± 10.74	45.1 ± 9.36	44.8 ± 10.01	45.3 ± 10.05
Oral antidiabetic treatment combination at study entry [units: participants]
sulfonylurea (SU) or meglitinide plus metformin	97	99	97	293
SU or meglitinide plus thiazolinedione (TZD)	9	9	10	28
TZD plus metformin	26	27	27	80
SU or meglitinide plus metformin plus TZD	63	61	63	187

Outcome Measures

Show All Outcome Measures

1. Primary:

Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - Intent To Treat (ITT) Population Without Good Clinical Practices (GCP) Noncompliant Sites) [ Time Frame: At week 60 ]

Show Outcome Measure 1

2. Primary:

Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30)Per Protocol Population [ Time Frame: At week 60 ]

Show Outcome Measure 2

3. Primary:

Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - ITT Population With All Sites) (Sensitivity Analysis) [ Time Frame: At week 60 ]

Show Outcome Measure 3

4. Secondary:

Absolute Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30) [ Time Frame: From baseline to week 60 ]

Show Outcome Measure 4

5. Secondary:

Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30) [ Time Frame: At week 60 ]

Show Outcome Measure 5

6. Secondary:

Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 Without a Severe Hypoglycemic Event or a Symptomatic Hypoglycemic Event With an Self Monitoring Blood Glucose (SMBG) <50 mg/dl [ Time Frame: At week 60 ]

Show Outcome Measure 6

7. Secondary:

Adjusted Incidence Rate of Hypoglycemia [ Time Frame: Week 60 ]

Show Outcome Measure 7

8. Secondary:

Adjusted Hypoglycemic Event Rates (Event/Patient-year) [ Time Frame: Week 60 ]

Show Outcome Measure 8

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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. Restriction Description: If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.

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
No text entered.

Results Point of Contact:

Name/Title: Trial Transparency Team
Organization: sanofi-aventis
e-mail: Contact-US@sanofi-aventis.com

No publications provided

Responsible Party:	Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00384085 History of Changes
Other Study ID Numbers:	HMR1964A_3515
Study First Received:	October 3, 2006
Results First Received:	March 31, 2011
Last Updated:	May 4, 2011
Health Authority:	United States: Food and Drug Administration