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

NCT03088670

NCT03088670
Completed Phase 3

Who may be able to join

Who might be able to join this trial:

  • You are between 18 and 78 years old
  • You have been officially diagnosed with type 2 diabetes
  • You have either never taken diabetes medication, or you have not taken any diabetes-lowering medication for at least 12 weeks before the screening visit
  • You are willing to use an appropriate method of contraception throughout the study
  • Your body mass index (a measure of weight relative to height) is between 22 and 40
  • Your HbA1c (a blood test showing average blood sugar over roughly 3 months) is between 7.5% and 11.0%
  • Your fasting blood sugar level is below 15 mmol/L (a blood test taken after not eating)
  • You are willing and able to sign a consent form agreeing to take part
  • You are able and willing to follow all the study requirements throughout the trial

Who may not be able to join:

  • You are pregnant, breastfeeding, planning to become pregnant during the study, or are a woman who could become pregnant and is not using an adequate method of contraception (confirm with trial site)
  • You have a history of type 1 diabetes or any other type of diabetes besides type 2
  • You have had a serious diabetes-related emergency, such as diabetic ketoacidosis or a hyperosmolar coma, within 6 weeks before screening (confirm with trial site)
  • You have serious diabetes complications, such as advanced eye disease, nerve damage affecting your internal organs, or a condition where your stomach empties too slowly
  • You have a known allergy or sensitivity to the study medications (Gosogliptin, Vildagliptin, or Metformin) or any of their ingredients
  • You have a seizure disorder, a systemic autoimmune or connective tissue disease requiring treatment with steroids or chemotherapy drugs, or have been diagnosed with cancer in the last 5 years (except a certain type of minor skin cancer)
  • You have had a significant heart or blood vessel problem in the last 12 months, including serious heart failure, uncontrolled irregular heartbeat, unstable chest pain, heart attack, heart surgery, stroke or mini-stroke, severely uncontrolled high blood pressure, or a blood clot in the lungs or legs
  • You have serious kidney problems, including kidney disease, high creatinine levels in your blood, or reduced kidney function below a certain level
  • You have hepatitis B, hepatitis C, liver cirrhosis, significantly raised liver enzyme levels, or high bilirubin levels (a measure of liver function)
  • You have HIV, or have had a serious infection that affected your blood sugar levels within 30 days before screening
  • You have anaemia (low red blood cell levels), have donated more than 500 mL of blood, or received a blood transfusion within 12 weeks before screening
  • You currently misuse drugs or alcohol
  • You have taken part in another clinical trial and received a study drug within 30 days before screening
  • You are unable to read or write, or are unwilling to understand and follow the study procedures

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
SatRx LLC
Registry
clinicaltrials_gov
Start date
23 April 2013
Est. completion
30 March 2014

Where this trial is recruiting

🇷🇺 Russia

Primary endpoints

Mean change of HbA1c

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