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

NCT02240680

NCT02240680
Completed Phase 4 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You must be willing to sign a consent form agreeing to take part in the trial before any assessments begin.
  • You must have been diagnosed with Type 2 Diabetes.
  • You must be 60 years of age or older when you sign the consent form.
  • You must have been taking a stable dose of a long-acting (basal) insulin for at least 4 weeks before joining, with only small dose changes (up to 20% either way) allowed.
  • You may or may not be taking metformin, but if you are, your dose must have been stable for at least 12 weeks before joining.
  • You may or may not be taking certain diabetes tablets called alpha-glucosidase inhibitors (such as acarbose), but if you are, your dose must have been stable for at least 12 weeks before joining.
  • Your HbA1c (a blood test that shows average blood sugar levels over time) must be between 7.0% and 10.0% at your first visit.
  • Your BMI (a measure of body weight relative to height) must be 45 or below at your first visit.
  • In the opinion of the trial doctor, you must be willing and able to follow all trial requirements reliably.

Who may not be able to join:

  • People who have significant difficulties with memory or thinking, based on a mental status test given at the first visit.
  • People showing signs of depression, based on a questionnaire score of 10 or more at the first visit.
  • People who have Type 1 Diabetes (rather than Type 2).
  • People who have had a heart attack, unstable chest pain, stroke, or mini-stroke (TIA) within the 3 months before their first visit.
  • People whose liver blood tests show results more than 3 times higher than normal at the screening or run-in stage.
  • People who have had weight-loss surgery (such as gastric bypass or gastric banding) within the past 2 years.
  • People who have had cancer or received cancer treatment within the last 5 years (skin cancers that were fully removed and were not invasive may be an exception — confirm with trial site).
  • People who have certain blood disorders that affect red blood cells, such as haemolytic anaemia, malaria, or babesiosis.

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 4: approximately Approved 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 4
Sponsor
Boehringer Ingelheim
Registry
clinicaltrials_gov
Start date
23 September 2014
Est. completion
18 April 2017

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇨🇴 Colombia 🇩🇰 Denmark 🇫🇮 Finland 🇩🇪 Germany 🇬🇷 Greece 🇮🇪 Ireland 🇯🇵 Japan 🇲🇽 Mexico 🇳🇿 New Zealand 🇵🇱 Poland 🇷🇴 Romania 🇿🇦 South Africa 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment.

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