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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT01798706

NCT01798706
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You are aged 70 years or older and have been diagnosed with type 2 diabetes that is not well controlled with your current diabetes medications
  • You are willing and able to sign a consent form agreeing to take part in the trial

Who may not be able to join:

  • Your blood sugar control reading (HbA1c) is either very well controlled (at or below 7.0%) or very poorly controlled (above 10%) at the screening visit
  • You are currently taking both a basal (long-acting) insulin and a certain type of diabetes pill called a sulfonylurea or meglitinide at the same time
  • Your fasting blood sugar level is above 250 mg/dL at the screening visit
  • You have type 1 diabetes, or have had a serious diabetes-related emergency called ketoacidosis in the past year
  • You were diagnosed with type 2 diabetes less than one year ago
  • Your current diabetes treatment has recently changed or was started within the last 3 months
  • You have taken certain diabetes medications not listed as allowed in this trial within the past 3 months (confirm with trial site for the full list of permitted medications)
  • You have ever taken a GLP-1 medication such as exenatide, liraglutide, or lixisenatide (or similar drugs)
  • You have had a severe low blood sugar episode in the past 6 months that caused you to be unaware of symptoms, lose consciousness, fall into a coma, or have a seizure
  • Your body mass index (a measure of body weight relative to height) is below 22 or above 40
  • You are assessed by the study doctor as being malnourished, or you score below 12 on a standard nutrition questionnaire
  • You have been assessed as having a cognitive disorder or dementia, score below 24 on a standard memory and thinking test, or have any nerve or brain condition that would affect your ability to take part in the study
  • Your kidneys are not working well enough, based on a specific measurement of kidney function (confirm with trial site)
  • You have a serious or uncontrolled illness, or any significant finding on physical examination that the study doctor believes would make it unsafe for you to participate
  • Certain blood test results at screening are abnormal, including raised levels of pancreas-related enzymes (amylase and/or lipase), liver enzymes (ALT or AST), or a hormone called calcitonin
  • You have or have had significant stomach or digestive problems involving long-lasting nausea and vomiting, such as gastroparesis or poorly controlled acid reflux, within the past 6 months
  • You have a history of unexplained or chronic pancreatitis, have had your pancreas or part of your stomach removed, or have inflammatory bowel disease
  • You or a close family member have a history of a specific type of thyroid cancer called medullary thyroid cancer, or a genetic condition that increases the risk of it

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.

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
Sanofi
Registry
clinicaltrials_gov
Start date
1 June 2013
Est. completion
1 February 2015

Where this trial is recruiting

🇦🇺 Australia 🇧🇬 Bulgaria 🇨🇦 Canada 🇩🇰 Denmark 🇩🇪 Germany 🇳🇴 Norway 🇵🇪 Peru 🇵🇱 Poland 🇿🇦 South Africa 🇪🇸 Spain 🇸🇪 Sweden 🇬🇧 United Kingdom 🇺🇸 United States

6 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Absolute Change in HbA1c From Baseline to Week 24

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov