The LANCET Trial: A Trial of Long-acting Insulin Injection to Reduce C-reactive Protein in Patients With Type 2 Diabetes

This study has been terminated.

( Interim analyses demonstrated futility. Thus, recruitment curtailed 10/08. )

Study NCT00366301 Information provided by Brigham and Women's Hospital

First Received on August 17, 2006. Last Updated on October 26, 2010 History of Changes

Results First Received: October 26, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Factorial Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Type 2 Diabetes
Interventions:	Drug: Insulin glargine injection Drug: metformin Drug: Placebo pill

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
Recruitment occurred at 73 US office-based practices between October 2006 and December 2008.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Preenrollment evaluation comprised local laboratory testing of hsCRP,HbA1c, and safety parameters (ALT or AST and creatinine). Eligible participants were enrolled in a 2-week run-in. Ability to self-monitor fingerstick blood glucose and perform insulin injection was determined and evaluation for evidence of marked hyperglycemia was undertaken.

Reporting Groups

	Description
Placebo Pill	Placebo pill
Metformin Pill	Metformin pill
Insulin Glargine Plus Placebo Pill	Insulin glargine plus placebo pill
Insulin Glargine Plus Metformin Pill	Insulin Glargine plus metformin pill

Participant Flow: Overall Study

	Placebo Pill	Metformin Pill	Insulin Glargine Plus Placebo Pill	Insulin Glargine Plus Metformin Pill
STARTED	124	126	126	124
Either 6W or 14W CRP Obtained	120	124	124	119
COMPLETED	116	120	122	116
NOT COMPLETED	8	6	4	8
Lost to Follow-up	4	4	3	7
Withdrawal by Subject	4	2	1	1

Baseline Characteristics

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Reporting Groups

	Description
Placebo Pill	Placebo pill
Metformin Pill	Metformin pill
Insulin Glargine Plus Placebo Pill	Insulin glargine plus placebo pill
Insulin Glargine Plus Metformin Pill	Insulin Glargine plus metformin pill

Baseline Measures

	Placebo Pill	Metformin Pill	Insulin Glargine Plus Placebo Pill	Insulin Glargine Plus Metformin Pill	Total
Number of Participants [units: participants]	124	126	126	124	500
Age [units: years] Mean ± Standard Deviation
Mean (SD)	54.0 ± 10.9	53.8 ± 11.5	53.8 ± 11.4	54.0 ± 11.7	53.9 ± 11.4
Gender [units: participants]
Female	64	68	83	66	281
Male	60	58	43	58	219
Ethnicity (NIH/OMB) [units: participants]
Hispanic or Latino	13	4	19	17	53
Not Hispanic or Latino	110	119	104	105	438
Unknown or Not Reported	1	3	3	2	9
Race/Ethnicity, Customized [units: Participants]
White	91	88	95	91	365
African American	25	34	25	24	108
Other	8	4	6	9	27

Outcome Measures

1. Primary:

Percentage Reduction in C-reactive Protein (CRP) [ Time Frame: 14 weeks ]

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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 NOT 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.

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: Aruna Pradhan
Organization: Brigham and Women's Hospital
phone: 617-732-8777
e-mail: apradhan@partners.org

No publications provided by Brigham and Women's Hospital

Publications automatically indexed to this study:

Pradhan AD, Everett BM, Cook NR, Rifai N, Ridker PM. Effects of initiating insulin and metformin on glycemic control and inflammatory biomarkers among patients with type 2 diabetes: the LANCET randomized trial. JAMA. 2009 Sep 16;302(11):1186-94.

Responsible Party:	Aruna Das Pradhan, MD, MPH, Brigham & Women's Hospital, Boston, Massachusetts 02115
ClinicalTrials.gov Identifier:	NCT00366301 History of Changes
Other Study ID Numbers:	2006-P-000823, Lantus_L_00833
Study First Received:	August 17, 2006
Results First Received:	October 26, 2010
Last Updated:	October 26, 2010
Health Authority:	United States: Institutional Review Board