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
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


  Baseline Characteristics
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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.
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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) ]

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) ]

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

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) ]

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) ]

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) ]

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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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