30 Week Parallel Group Comparison Study of Linagliptin + Pioglitazone (5+15, 5+30 and 5+45 mg) qd Versus Respective Monotherapies, Followed by a Comparison of 5mg+30mg and 5mg+45mg Versus Respective Monotherapies in Type 2 Diabetes for up to 54 Weeks

Recruiting in Palo Alto (17 mi)

+131 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Boehringer Ingelheim

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The primary objective is to demonstrate superior glycaemic control (HbA1c reduction) after 30 weeks of linagliptin/pioglitazone (5/15, 5/30 and 5/45 mg) versus the respective individual monotherapies of pioglitazone (15 mg, 30 mg, or 45 mg, administered orally once daily), and linagliptin (5 mg, administered orally once daily). In addition, durability of treatment effect and safety under chronic treatment conditions will be investigated.

Research Team

Boehringer Ingelheim

Principal Investigator

Boehringer Ingelheim

Eligibility Criteria

Inclusion Criteria

Diagnosis of type 2 diabetes mellitus prior to informed consent

Male and female patients with insufficient glycaemic control (HbA1c >= 7.0 to <= 10.5% at Visit 2) on diet and exercise alone, without oral antidiabetic drug therapy within 10 weeks prior to start of the run-in period (date of Visit 2)

Age >= 18 and <= 80 years at start date of Visit 1 (Screening)

Treatment Details

Interventions

• Linagliptin (Dipeptidyl Peptidase-4 (DPP-4) Inhibitor)
• Pioglitazone (Thiazolidinedione)

Participant Groups

Group I: Linagliptin 5mg / Pioglitazone 45 mg Experimental Treatment 1 Intervention

Linagliptin 5mg / Pioglitazone 45 mg Tablets once daily

Group II: Linagliptin 5mg / Pioglitazone 30 mg Experimental Treatment 1 Intervention

Linagliptin 5mg / Pioglitazone 30 mg Tablets once daily

Group III: Linagliptin 5mg / Pioglitazone 15 mg Experimental Treatment 1 Intervention

Linagliptin 5mg / Pioglitazone 15 mg Tablets once daily

Group IV: Pioglitazone 30 mg Active Control 1 Intervention

Pioglitazone Capsules 30 mg once daily

Group V: Pioglitazone 15 mg Active Control 1 Intervention

Pioglitazone Capsules 15 mg once daily

Group VI: Linagliptin 5mg Active Control 1 Intervention

Linagliptin 5mg Tablets once daily

Group VII: Pioglitazone 45 mg Active Control 1 Intervention

Pioglitazone Capsules 45 mg once daily

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University