Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (known as ORIGIN) enrolled 12,537 people in total — 6,264 assigned to receive insulin glargine (a long-acting insulin) and 6,273 assigned to standard care. Participants had either type 2 diabetes, or blood sugar levels that were higher than normal but not yet at diabetes level (sometimes called "pre-diabetes"). The trial was measuring whether insulin glargine made any difference to serious heart and blood vessel events, kidney and eye complications, and — for those without diabetes at the start — whether they went on to develop type 2 diabetes. The reported data shows that for the main heart-related outcome (a combined count of cardiovascular death, non-fatal heart attack, or non-fatal stroke), 1,041 participants in the insulin glargine group and 1,013 in the standard care group experienced one of these events. For a broader heart-related outcome that also included procedures to restore blood flow and hospital admissions for heart failure, the reported figures were 1,792 (insulin glargine) and 1,727 (standard care). For deaths from any cause, 951 people in the insulin glargine group and 965 in the standard care group died. For kidney or eye complications combined, 1,323 (insulin glargine) and 1,363 (standard care) participants experienced at least one such event. Among participants who did not have diabetes at the start of the trial, 24.7% in the insulin glargine group and 31.2% in the standard care group were reported to have developed type 2 diabetes by the end of the study. Regarding low blood sugar episodes (hypoglycaemia), the reported data shows that 3,597 participants in the insulin glargine group and 1,624 in the standard care group experienced symptomatic episodes of any kind, with severe episodes (requiring another person's help) reported in 352 and 113 participants respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 22686416) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Type 2 Diabetes Trial, Completed
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- You have been found to have higher-than-normal blood sugar levels (either mildly high fasting sugar, mildly high sugar after eating, or early type 2 diabetes) based on a specific blood sugar test.
- If you have early type 2 diabetes, you must either be taking no diabetes medication, or be taking just one type of oral diabetes pill at a stable dose for at least 10 weeks, with your blood sugar levels not too high (confirm with trial site for exact numbers).
- You are a man or woman aged 50 years or older.
- You have at least one heart or blood vessel risk factor, such as a previous heart attack, stroke, heart procedure, chest pain with confirmed reduced blood flow to the heart, kidney protein leakage, an enlarged heart muscle, significant narrowing of arteries, or a low ankle-to-arm blood pressure ratio.
- You have signed and dated a consent form before any study procedures begin.
- You are able and willing to fill out study diaries and questionnaires.
- You have shown that you can use a blood sugar monitoring device and give yourself an injection before the study starts.
- If you are a woman who could become pregnant, you must have a negative pregnancy test and agree to use reliable birth control for the whole study.
- You are willing to stop taking omega-3 fish oil supplements for the duration of the study.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- You have type 1 diabetes.
- You currently need insulin injections for your diabetes, or your blood sugar is so uncontrolled that you are likely to need insulin or a new diabetes medication very soon.
- You have previously tested positive for a specific antibody linked to type 1 diabetes (anti-GAD antibody).
- Your blood sugar (HbA1c) level is too high at the screening visit (confirm with trial site for exact threshold).
- You are unwilling to give yourself injections or check your own blood sugar levels.
- You did not complete a required practice period of injecting a dummy (placebo) insulin and checking blood sugar for at least 4 days before the study start.
- You have had or are planning to have coronary bypass heart surgery (CABG) within the past 4 years (with some exceptions — confirm with trial site).
- Your kidneys are not working well enough, based on a blood test at screening.
- You have active liver disease or abnormal liver test results at screening.
- You regularly use steroid medications (taken by mouth or injection) or take niacin for high cholesterol.
- You have severe heart failure (classified as Class III or IV — confirm with trial site).
- You are not expected to survive more than 3 years due to a non-heart condition, such as cancer.
- There is any other reason that makes it unlikely you could follow the study rules or report side effects properly.
- You are unwilling or unable to stop taking a type of diabetes pill called a thiazolidinedione (TZD).
- You are currently taking part in another clinical trial involving an active medication.
- You are unwilling to allow the study site to contact your own doctor to share information about the study and your treatment.
- You have had an allergic reaction to any of the study medications in the past.
- You have already taken part in this study before.
- You have had a heart transplant or are currently waiting for one.
- You are known to be infected with HIV.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Trial contact details on record
Principal Investigator: Clinical Sciences & Operations, Sanofi
Australian sites
This trial is not accepting new participants. These are the contact details ClinicalTrials.gov holds for it, kept here for reference. They are not an invitation to enrol, and the sites listed may no longer be running this trial.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial was run
These are the locations recorded on the registry, including 1 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke; Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF)
Other options
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.