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Thiazolidinedione

Alogliptin 25 mg + Pioglitazone 30 mg add-on to Metformin for Diabetes

Phase 3
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and weeks 2, 4, 8, 12, 16, 20, 26, 34, 42 and 52.
Awards & highlights
All Individual Drugs Already Approved
Approved for 20 Other Conditions
Pivotal Trial

Summary

The purpose of the study is to compare the effect of adding alogliptin, once daily (QD), to the ongoing treatment regimen of pioglitazone HCl and metformin in patients with inadequate glycemic control.

Eligible Conditions
  • Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and weeks 2, 4, 8, 12, 16, 20, 26, 34, 42 and 52.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and weeks 2, 4, 8, 12, 16, 20, 26, 34, 42 and 52. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Secondary study objectives
Change From Baseline in Adiponectin
Change From Baseline in Apolipoprotein A1
Change From Baseline in Apolipoprotein A2
+37 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Alogliptin 25 mg + Pioglitazone 30 mg add-on to MetforminExperimental Treatment4 Interventions
Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
Group II: Pioglitazone 45 mg add-on to MetforminActive Control3 Interventions
Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
FDA approved
Pioglitazone
FDA approved
Placebo
1995
Completed Phase 3
~2670
Alogliptin
FDA approved

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,235 Previous Clinical Trials
4,147,102 Total Patients Enrolled
8 Trials studying Diabetes
203,541 Patients Enrolled for Diabetes
VP Biological SciencesStudy DirectorTakeda
16 Previous Clinical Trials
9,409 Total Patients Enrolled
~43 spots leftby Nov 2025
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