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 329 people across three groups: 65 received a placebo (a dummy pill with no active ingredient), 133 received a lower dose of alogliptin (12.5 mg once daily), and 131 received a higher dose of alogliptin (25 mg once daily). The trial was measuring changes in a blood marker called HbA1c — this is a measure of how much sugar has been attached to red blood cells over the past few months, expressed as a percentage. A lower HbA1c percentage is generally associated with lower blood sugar levels. The study ran for 26 weeks. Not everyone completed the trial: 40 of the 65 placebo participants, 105 of the 133 lower-dose participants, and 107 of the 131 higher-dose participants finished the full study period. The reported data shows that, for the main outcome measured at 26 weeks, the placebo group's HbA1c changed by an average of −0.02 percentage points from their starting level. The lower-dose alogliptin group showed an average change of −0.56 percentage points, and the higher-dose group showed an average change of −0.59 percentage points. The secondary outcomes tracked HbA1c at earlier time points (weeks 4, 8, 12, 16, and 20). The reported data shows that across all of these earlier time points, the placebo group's readings changed by between −0.11 and −0.13 percentage points, while both alogliptin groups showed larger reported changes ranging roughly from −0.37 to −0.66 percentage points depending on the time point and dose. 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 18809631) ↗
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
Who may 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 might be able to join this trial:
- You have been diagnosed with type 2 diabetes and your blood sugar is not well controlled, without currently taking any diabetes medication.
- You tried managing your diabetes with diet and exercise for at least one month before the screening visit, but it was not enough.
- You have taken diabetes medication for fewer than 7 days total in the 3 months before the screening visit.
- Your body mass index (a measure of body weight relative to height) is between 23 and 45.
- A blood test shows your body is still producing some insulin on its own (confirm with trial site for exact values).
- Your HbA1c (a measure of average blood sugar over several months) is between 7.0% and 10.0%.
- If you regularly take other medications (not related to diabetes), your dose has been stable for at least 4 weeks before the screening visit.
- Your blood pressure reading is no higher than 180/110 mmHg.
- Your blood count (hemoglobin) meets the minimum level required — the level differs slightly for men and women (confirm with trial site).
- Your liver function, kidney function, and thyroid levels are within acceptable ranges based on blood tests.
- You are not currently pregnant or breastfeeding.
- If you are a woman who could become pregnant, you are willing and able to use reliable contraception throughout the entire study.
- You are willing and able to check your own blood sugar at home using a glucose monitor.
- You are generally healthy enough, in the opinion of the study doctor, to complete the trial.
- You are willing and able to sign a consent form agreeing to take part.
Who may not be able to join:
- A urine test shows very high levels of protein in your urine (a sign of kidney stress), though you may be able to be retested within one week.
- You have a history of cancer (other than certain common skin cancers) that has not been fully in remission for at least 5 years.
- You have had laser eye treatment for diabetes-related eye disease in the 6 months before the screening visit.
- You have been treated for stomach problems caused by diabetes (a condition called diabetic gastroparesis).
- You have been diagnosed with moderate to severe heart failure (confirm with trial site for specific classification).
- You have had a heart procedure (such as bypass surgery, stent, or angioplasty) or a heart attack in the 6 months before the screening visit.
- You have a blood condition that would make the HbA1c blood sugar test unreliable.
- You have a history of hepatitis B, hepatitis C, or HIV infection.
- You have a psychiatric condition that could affect your ability to take part in the study.
- You have had a severe allergic reaction (swelling under the skin) caused by certain blood pressure medications (confirm with trial site).
- You have had problems with alcohol or drug misuse in the 2 years before the screening visit.
- You have taken part in another drug trial within the past 30 days, or an experimental diabetes drug trial within the past 3 months.
- You have previously taken part in a trial of the study drug alogliptin.
- You are currently taking or have recently taken diabetes medications, weight-loss drugs, steroid tablets or injections, or other experimental drugs (certain exceptions may apply — confirm with trial site).
- You are taking any medication — including over-the-counter products — without the study doctor's approval.
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.
Contact this trial
Principal Investigator: VP Biological Sciences, Takeda
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.