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Thiazolidinedione

Efficacy of Alogliptin and Pioglitazone in Subjects With Type 2 Diabetes Mellitus

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and weeks 2, 4, 8, 12, 16, 20, 26, 34, 42 and 52.

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

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