Phase 2 Type 2 Diabetes Trial, Completed NCT01649297 Sponsor: Boehringer Ingelheim Condition: Type 2 Diabetes
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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 enrolled 983 people across five groups to compare four different doses and dosing schedules of a medicine called empagliflozin against a placebo (a dummy treatment with no active ingredient) in people with type 2 diabetes. The four empagliflozin groups tested either 5 mg or 12.5 mg taken twice a day, or 10 mg or 25 mg taken once a day. The main thing the trial was measuring was a blood marker called HbA1c — a way of tracking average blood sugar levels over roughly three months — after 16 weeks of treatment. A secondary measure was fasting plasma glucose, which is a person's blood sugar level after not eating overnight. The reported data shows that all five groups, including the placebo group, had a reduction in HbA1c from their starting levels. The placebo group's average change was −0.22 percentage points. The four empagliflozin groups showed average changes ranging from −0.64 to −0.83 percentage points, with the 12.5 mg twice-daily group showing the largest reported reduction and the 10 mg once-daily group the smallest among the active treatment groups. For fasting blood sugar, the reported data shows the placebo group had an average change of −0.2 mg/dL, while the empagliflozin groups ranged from −17.6 to −27.7 mg/dL, again with the 12.5 mg twice-daily group showing the largest reported change. These numbers reflect averages across the study groups and do not tell us what any individual person experienced. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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 2 Type 2 Diabetes Trial, Completed

NCT01649297
Completed Phase 2 🇦🇺 Australian site

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 diagnosed with Type 2 diabetes
  • Your HbA1c blood sugar level (a measure of average blood sugar over 2–3 months) is between 7.0% and 10.0%
  • You are already taking Metformin at a dose of at least 1500 mg per day, taken twice daily
  • You are 18 years of age or older
  • Your body mass index (BMI, a measure of body weight relative to height) is 45 or below

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.

  • Your kidneys are not filtering blood well enough, based on a specific calculation using a substance called creatinine in your blood (confirm with trial site)
  • Your blood sugar level was found to be above 240 mg/dl after fasting overnight during an early stage of the trial

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 14 July 2026

Trial contact details on record

Principal Investigator: Boehringer Ingelheim, Boehringer Ingelheim

Australian sites

1276.10.61002 Boehringer Ingelheim Investigational Site, Wollongong, New South Wales
1276.10.61001 Boehringer Ingelheim Investigational Site, Box Hill, Victoria

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

Status
Completed
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 October 2012
Est. completion
1 December 2013

Where this trial was run

🇦🇺 Australia 🇨🇦 Canada 🇪🇪 Estonia 🇫🇷 France 🇬🇪 Georgia 🇩🇪 Germany Guatemala 🇮🇹 Italy 🇱🇻 Latvia 🇱🇹 Lithuania 🇲🇽 Mexico 🇳🇿 New Zealand 🇵🇱 Poland 🇷🇺 Russia 🇿🇦 South Africa 🇪🇸 Spain 🇺🇦 Ukraine 🇺🇸 United States

These are the locations recorded on the registry, including 2 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16

Other options

Expanded access pathways

This trial is not enrolling. Other access pathways exist in general: in Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients. Whether it applies to any treatment studied here is a question for your doctor — nothing on this page says it does.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov