The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)

This study has been completed.

Sponsor:

Collaborator:

Population Health Research Institute

Information provided by (Responsible Party):

Sanofi

ClinicalTrials.gov Identifier:

NCT00069784

First received: October 1, 2003

Last updated: January 24, 2013

Last verified: January 2013

History of Changes

Results First Received: December 18, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Factorial Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Diabetes Mellitus, Non-Insulin-Dependent
Interventions:	Drug: insulin glargine (HOE901) Drug: omega-3 polyunsaturated fatty acids (PUFA) Drug: placebo Device: reusable pen device for insulin injection

Participant Flow

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Baseline Characteristics

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Reporting Groups

	Description
Insulin Glargine	Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
Standard Care	Standard care with or without omega-3 polyunsaturated fatty acids
Total	Total of all reporting groups

Baseline Measures

	Insulin Glargine	Standard Care	Total
Number of Participants [units: participants]	6264	6273	12537
Age [units: years] Mean ± Standard Deviation	63.5 ± 7.8	63.5 ± 7.9	63.5 ± 7.8
Gender, Customized [units: participants]
Male	4181	3969	8150
Female	2082	2304	4386
Missing value	1	0	1
Baseline Weight ^[1] [units: kg] Mean ± Standard Deviation	83.33 ± 16.77	83.13 ± 17.28	83.23 ± 17.03
Baseline Body Mass Index ^[2] [units: kg/m²] Mean ± Standard Deviation	29.77 ± 5.17	29.88 ± 5.33	29.82 ± 5.25
Any previous cardiovascular event [units: participants]
No	2552	2607	5159
Yes	3712	3666	7378
Diabetes diagnosis at time of screening ^[3] [units: participants]
IFG and/or IGT	735	717	1452
Newly diagnosed diabetic	365	395	760
Established diabetes with no OAD treatment	1414	1467	2881
Established diabetes with one OAD treatment	3748	3692	7440
Unclear diabetes status	2	2	4
Duration of diabetes for established diabetes patients ^[4] [units: years] Median ( Inter-Quartile Range )	3.50 ( 1.50 to 7.50 )	3.50 ( 1.50 to 7.50 )	3.50 ( 1.50 to 7.50 )
Glycated Hemoglobin A1c (HbA1c) ^[5] [units: percent] Median ( Inter-Quartile Range )	6.41 ( 5.81 to 7.18 )	6.40 ( 5.81 to 7.16 )	6.40 ( 5.81 to 7.18 )
Fasting Plasma Glucose ^[6] [units: mmol/L] Median ( Inter-Quartile Range )	6.94 ( 6.05 to 8.20 )	6.90 ( 6.00 to 8.20 )	6.94 ( 6.05 to 8.20 )

[1]	Due to missing values, N=6256 for insulin glargine and N=6271 for standard care.
[2]	Due to missing values, N=6251 for insulin glargine and N=6270 for standard care.
[3]	IFG = Impaired Fasting Glucose defined as a Postprandial Plasma Glucose (PPG) value ≥140 and <200 mg/dL (ie, ≥7.8 and <11.1 mmol/L), with a Fasting Plasma Glucose (FPG) <126 mg/dL (7.0 mmol/L) IGT = Impaired Glucose Tolerance defined as an FPG ≥110 and <126 mg/dL (≥6.1 and <7 mmol/L), without diabetes mellitus (PPG must be <200 mg/dL [11.1 mmol/L]) OAD = oral antidiabetic drug
[4]	Population of patients with established diabetes. Due to missing values, N=5148 for insulin glargine and N=5141 for standard care.
[5]	Due to missing values, N=6175 for insulin glargine and N=6189 for standard care.
[6]	Due to missing values, N=6248 for insulin glargine and N=6266 for standard care.

Outcome Measures

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1. Primary:

Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke [ Time Frame: from randomization until study cut-off date (median duration of follow-up: 6.2 years) ]

Measure Type	Primary
Measure Title	Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke
Measure Description	Number of participants with a first occurrence of one of the above events. The outcome's evaluation is based on the number of such positively-adjudicated first events occurring for patients assigned to the study groups. Assessments of the above events were reviewed by the Event Adjudication Committee who was kept blinded to the group assignment of participants. Statistical analysis is performed on the time from randomization to the first occurrence of the events. Number of participants with a composite endpoint (i.e. with first occurrence of CV death, nonfatal MI or nonfatal stroke) is provided in the first row of the statistical table.
Time Frame	from randomization until study cut-off date (median duration of follow-up: 6.2 years)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was based on the intent-to-treat (ITT) population i.e. all randomized participants. For the endpoint's composition, the numbers only summarize the event when it was the first occurrence of the endpoint. A participant is counted only once within a category. The same participant may appear in different categories.

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

The analysis was based on the intent-to-treat (ITT) population i.e. all randomized participants.

For the endpoint's composition, the numbers only summarize the event when it was the first occurrence of the endpoint. A participant is counted only once within a category. The same participant may appear in different categories.

Reporting Groups

	Description
Insulin Glargine	Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
Standard Care	Standard care with or without omega-3 polyunsaturated fatty acids

Measured Values

	Insulin Glargine	Standard Care
Number of Participants Analyzed [units: participants]	6264	6273
Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke [units: participants]
Participants with a composite endpoint	1041	1013
Endpoint's composition: CV death	484	476
Endpoint's composition: nonfatal MI	297	282
Endpoint's composition: nonfatal stroke	261	256

Statistical Analysis 1 for Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke

Groups ^[1]	All groups
Method ^[2]	Log Rank
P Value ^[3]	0.6273
Cox Proportional Hazard ^[4]	1.022
95% Confidence Interval	( 0.937 to 1.114 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The total required number of first coprimary outcomes (2200) assumed that a hazard reduction of 14-16% was clinically significant and controlled the overall experiment-wise Type 1 error at 5% with a power of 80% for each outcome. The total number of participants needed to achieve this number of events within the planned enrollment and treatment periods was ultimately estimated to be 12 500 based on the CURE and HOPE study databases.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Log-rank test stratified by double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	For the analysis of the two coprimary efficacy outcomes, the overall Type 1 error was partitioned. The first coprimary outcome was tested at 4.4%, whereas the second coprimary outcome was tested at 1% (weighted Hochberg procedure).
[4]	Other relevant estimation information:
	Hazard ratio (glargine/standard care) estimated by Cox regression model with treatment (glargine, standard care) as factor, stratified by double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event.

2. Primary:

Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF) [ Time Frame: from randomization until study cut-off date (median duration of follow-up: 6.2 years) ]

Measure Type	Primary
Measure Title	Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF)
Measure Description	Number of participants with a first occurrence of one of the above events (revascularization procedures included coronary artery bypass graft, percutaneous transluminal coronary angioplasty (PTCA) i.e. balloon, PTCA with stent, other percutaneous intervention, carotid angioplasty with/without stent, carotid endarterectomy, peripheral angioplasty with or without stent, peripheral vascular surgery, and limb amputation due to vascular disease). The outcome's evaluation is based on the number of such positively-adjudicated first events occurring for patients assigned to the study groups. Assessments of the above events were reviewed by the Event Adjudication Committee who was kept blinded to the group assignment of participants. Statistical analysis is performed on the time from randomization to the first occurrence of the events. Number of participants with a composite endpoint (i.e. with first occurrence of the events) is provided in the first row of the statistical table.
Time Frame	from randomization until study cut-off date (median duration of follow-up: 6.2 years)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was based on the intent-to-treat (ITT) population i.e. all randomized participants. For the endpoint's composition, the numbers only summarize the event when it was the first occurrence of the endpoint. A participant is counted only once within a category. The same participant may appear in different categories.

The analysis was based on the intent-to-treat (ITT) population i.e. all randomized participants.

Reporting Groups

	Description
Insulin Glargine	Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
Standard Care	Standard care with or without omega-3 polyunsaturated fatty acids

Measured Values

	Insulin Glargine	Standard Care
Number of Participants Analyzed [units: participants]	6264	6273
Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF) [units: participants]
Participants with a composite endpoint	1792	1727
Endpoint's composition: CV death	350	339
Endpoint's composition: nonfatal MI	257	238
Endpoint's composition: nonfatal stroke	231	227
Endpoint's composition: revascularization	763	717
Endpoint's composition: hospitalization for HF	249	259

Statistical Analysis 1 for Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF)

Groups ^[1]	All groups
Method ^[2]	Log Rank
P Value ^[3]	0.2692
Cox Proportional Hazard ^[4]	1.038
95% Confidence Interval	( 0.972 to 1.109 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	See above additional details provided for the analysis of the first coprimary outcome.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Log-rank test stratified by double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	The second coprimary outcome was tested at 1% (see above additional information for the first coprimary outcome).
[4]	Other relevant estimation information:
	Hazard ratio (glargine/standard care) estimated by Cox regression model with treatment (glargine, standard care) as factor, stratified by double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event.

3. Secondary:

Total Mortality (All Causes) [ Time Frame: from randomization until study cut-off date (median duration of follow-up: 6.2 years) ]

Measure Type	Secondary
Measure Title	Total Mortality (All Causes)
Measure Description	Number of deaths due to any cause
Time Frame	from randomization until study cut-off date (median duration of follow-up: 6.2 years)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was based on the intent-to-treat (ITT) population, which was all randomized participants, regardless of compliance with the protocol.

Reporting Groups

	Description
Insulin Glargine	Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
Standard Care	Standard care with or without omega-3 polyunsaturated fatty acids

Measured Values

	Insulin Glargine	Standard Care
Number of Participants Analyzed [units: participants]	6264	6273
Total Mortality (All Causes) [units: participants]	951	965

Statistical Analysis 1 for Total Mortality (All Causes)

Groups ^[1]	All groups
Cox Proportional Hazard ^[2]	0.983
95% Confidence Interval	( 0.899 to 1.076 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant estimation information:
	Hazard ratio (glargine/standard care) estimated by Cox regression model with treatment (glargine, standard care) as factor, with double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event as covariates.

4. Secondary:

Composite Diabetic Microvascular Outcome (Kidney or Eye Disease) [ Time Frame: from randomization until study cut-off date (median duration of follow-up: 6.2 years) ]

Measure Type	Secondary
Measure Title	Composite Diabetic Microvascular Outcome (Kidney or Eye Disease)
Measure Description	The composite outcome used to analyze microvascular disease progression contained components of clinical events: the occurrence of laser surgery or vitrectomy for diabetic retinopathy (DR); the development of blindness due to DR; the occurrence of renal death or renal replacement therapy; as well as the following laboratory-based events: doubling of serum creatinine; or progression of albuminuria (from none to microalbuminuria [at least 30 mg/g creatinine], to macroalbuminuria [at least 300 mg/g creatinine]).
Time Frame	from randomization until study cut-off date (median duration of follow-up: 6.2 years)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was based on the intent-to-treat (ITT) population i.e. all randomized participants. For the endpoint's composition, the numbers only summarize the event when it was the first occurrence of the endpoint. A participant is counted only once within a category. The same participant may appear in different categories.

The analysis was based on the intent-to-treat (ITT) population i.e. all randomized participants.

Reporting Groups

	Description
Insulin Glargine	Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
Standard Care	Standard care with or without omega-3 polyunsaturated fatty acids

Measured Values

	Insulin Glargine	Standard Care
Number of Participants Analyzed [units: participants]	6264	6273
Composite Diabetic Microvascular Outcome (Kidney or Eye Disease) [units: participants]
Participants with a composite endpoint	1323	1363
Endpoint's composition: vitrectomy	24	25
Endpoint's composition: laser therapy for DR	57	67
Endpoint's composition: dialysis	18	28
Endpoint's composition: renal transplant	0	0
Endpoint's composition: serum creatinine doubled	82	88
Endpoint's composition: death due to renal failure	4	3
Endpoint's composition: albuminuria progression	1153	1171

Statistical Analysis 1 for Composite Diabetic Microvascular Outcome (Kidney or Eye Disease)

Groups ^[1]	All groups
Cox Proportional Hazard ^[2]	0.970
95% Confidence Interval	( 0.900 to 1.047 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant estimation information:
	Hazard ratio (glargine/standard care) estimated by Cox regression model with treatment (glargine, standard care) as factor, with double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event as covariates.

5. Secondary:

Incidence of Development of Type 2 Diabetes Mellitus in Participants With IGT and/or IFG [ Time Frame: from randomization until the last follow-up visit or last OGTT (median duration of follow-up: 6.2 years) ]

Measure Type	Secondary
Measure Title	Incidence of Development of Type 2 Diabetes Mellitus in Participants With IGT and/or IFG
Measure Description	The incidence was determined by calculating the proportion of randomized participants without diabetes at randomization who either developed diabetes during the study or who were classified as having possible diabetes based on results of two oral glucose tolerance tests (OGTT) performed after the last follow-up visit (within 21-28 days for OGTT#1 and within 10-14 weeks for OGTT#2).
Time Frame	from randomization until the last follow-up visit or last OGTT (median duration of follow-up: 6.2 years)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was based on the subgroup of the intent-to-treat (ITT) population without diabetes at randomization.

Reporting Groups

	Description
Insulin Glargine	Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
Standard Care	Standard care with or without omega-3 polyunsaturated fatty acids

Measured Values

	Insulin Glargine	Standard Care
Number of Participants Analyzed [units: participants]	737	719
Incidence of Development of Type 2 Diabetes Mellitus in Participants With IGT and/or IFG [units: percentage of patients]	24.7	31.2

Statistical Analysis 1 for Incidence of Development of Type 2 Diabetes Mellitus in Participants With IGT and/or IFG

Groups ^[1]	All groups
Odds Ratio (OR) ^[2]	0.72
95% Confidence Interval	( 0.58 to 0.91 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant estimation information:
	Odds ratio estimated using Cochran-Mantel-Haenszel (CMH) test method stratified by double-blind treatment (omega-3 PUFA or placebo) and previous cardiovascular event (yes or no).

6. Other Pre-specified:

Number of Patients With Various Types of Symptomatic Hypoglycemia Events [ Time Frame: on-treatment period (median duration of follow-up: 6.2 years) ]

Measure Type	Other Pre-specified
Measure Title	Number of Patients With Various Types of Symptomatic Hypoglycemia Events
Measure Description	Symptomatic hypoglycemia was defined as an event with clinical symptoms consistent with hypoglycemia, based on data recorded in the participant’s diary. These were further categorized as confirmed (ie, with a concomitant home glucose reading ≤54 mg/dL [≤3.0 mmol/L]) or unconfirmed. Severe hypoglycemia was defined as an event with clinical symptoms consistent with hypoglycemia in which the participant required the assistance of another person, and one of the following: the event was associated with a documented self-measured or laboratory plasma glucose level ≤36 mg/dL (≤2.0 mmol/L), or the event was associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration.
Time Frame	on-treatment period (median duration of follow-up: 6.2 years)
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The population analyzed was the safety population consisting of all randomized and treated patients (who received at least one dose of study drug) for the insulin glargine group and of all randomized patients for the standard care group.

Reporting Groups

	Description
Insulin Glargine	Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
Standard Care	Standard care with or without omega-3 polyunsaturated fatty acids

Measured Values

	Insulin Glargine	Standard Care
Number of Participants Analyzed [units: participants]	6231	6273
Number of Patients With Various Types of Symptomatic Hypoglycemia Events [units: participants]
Patients with hypoglycemia events	3597	1624
Patients with non-severe hypoglycemia	3533	1582
Patients with confirmed non-severe hypoglycemia	2581	904
Patients with severe hypoglycemia	352	113

No statistical analysis provided for Number of Patients With Various Types of Symptomatic Hypoglycemia Events

7. Other Pre-specified:

Number of Patients With First Occurrence of Any Type of Cancer [ Time Frame: from randomization until study cut-off date (median duration of follow-up: 6.2 years) ]

Measure Type	Other Pre-specified
Measure Title	Number of Patients With First Occurrence of Any Type of Cancer
Measure Description	Data on cancers that occurred in association with hospitalizations were collected systematically in both groups from the start of the study. All reported cancers occurring during the trial (new or recurrent) were adjudicated by the Event Adjudication Committee.
Time Frame	from randomization until study cut-off date (median duration of follow-up: 6.2 years)
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was based on the intent-to-treat (ITT) population.

Reporting Groups

	Description
Insulin Glargine	Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
Standard Care	Standard care with or without omega-3 polyunsaturated fatty acids

Measured Values

	Insulin Glargine	Standard Care
Number of Participants Analyzed [units: participants]	6264	6273
Number of Patients With First Occurrence of Any Type of Cancer [units: participants]	559	561

No statistical analysis provided for Number of Patients With First Occurrence of Any Type of Cancer

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. Restriction Description: "The Steering Committee will be responsible for preparing summaries of the study results for publication in the medical literature, and will have the right to submit such summaries for publication after a review by the sponsor. In such cases comments from the sponsor to the Steering Committee are to be provided within 15 working days. All comments will be carefully considered by the Steering Committee who nevertheless have the final decision on the content of the manuscript."

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
e-mail: Contact_US@sanofi.com

Publications of Results:

ORIGIN Trial Investigators, Gerstein HC, Bosch J, Dagenais GR, Díaz R, Jung H, Maggioni AP, Pogue J, Probstfield J, Ramachandran A, Riddle MC, Rydén LE, Yusuf S. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med. 2012 Jul 26;367(4):319-28. Epub 2012 Jun 11.

ORIGIN Trial Investigators, Bosch J, Gerstein HC, Dagenais GR, Díaz R, Dyal L, Jung H, Maggiono AP, Probstfield J, Ramachandran A, Riddle MC, Rydén LE, Yusuf S. n-3 fatty acids and cardiovascular outcomes in patients with dysglycemia. N Engl J Med. 2012 Jul 26;367(4):309-18. Epub 2012 Jun 11.

Other Publications:

Origin Trial Investigators, Gerstein H, Yusuf S, Riddle MC, Ryden L, Bosch J. Rationale, design, and baseline characteristics for a large international trial of cardiovascular disease prevention in people with dysglycemia: the ORIGIN Trial (Outcome Reduction with an Initial Glargine Intervention). Am Heart J. 2008 Jan;155(1):26-32, 32.e1-6. Epub 2007 Nov 26.

Hanefeld M, Koehler C, Hoffmann C, Wilhelm K, Kamke W, Gerstein H. Effect of targeting normal fasting glucose levels with basal insulin glargine on glycaemic variability and risk of hypoglycaemia: a randomized, controlled study in patients with early Type 2 diabetes. Diabet Med. 2010 Feb;27(2):175-80.

Badings EA, Dyal L, Schoterman L, Lok DJ, Stoel I, Gerding MN, Gerstein HC, Tijssen JG. Strategies to detect abnormal glucose metabolism in people at high risk of cardiovascular disease from the ORIGIN (Outcome Reduction with Initial Glargine Intervention) trial population. J Diabetes. 2011 Sep;3(3):232-7. doi: 10.1111/j.1753-0407.2011.00124.x.

Ramachandran A, Riddle MC, Kabali C, Gerstein HC; ORIGIN Investigators. Relationship between A1C and fasting plasma glucose in dysglycemia or type 2 diabetes: an analysis of baseline data from the ORIGIN trial. Diabetes Care. 2012 Apr;35(4):749-53. Epub 2012 Feb 8.

Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT00069784 History of Changes
Other Study ID Numbers:	LTS6035, HOE901/4032
Study First Received:	October 1, 2003
Results First Received:	December 18, 2012
Last Updated:	January 24, 2013
Health Authority:	United States: Food and Drug Administration

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