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NCT00996658 · ClinicalTrials.gov registry record · Phase 3

Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone

A Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 3
Development phase
278
Enrollment target
20
Study locations

NCT00996658: Completed Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Boehringer Ingelheim.

NCT00996658 is a Phase 3 study of Diabetes Mellitus, Type 2 that has completed, run by Boehringer Ingelheim. The registered enrollment target is 278 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00996658, a Phase 3 study of Diabetes Mellitus, Type 2, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 3
Development phase
278 participants
Enrollment target
20
Study locations

Study Summary

The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add on therapy to metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Primary Outcome

Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Linagliptin

Study Locations (20)

California

  • 1218.61.01028 Boehringer Ingelheim Investigational Site - Escondido
  • 1218.61.01014 Boehringer Ingelheim Investigational Site - Greenbrae
  • 1218.61.01015 Boehringer Ingelheim Investigational Site - Los Angeles
  • 1218.61.01042 Boehringer Ingelheim Investigational Site - Paramount
  • 1218.61.01046 Boehringer Ingelheim Investigational Site - Poway
  • 1218.61.01044 Boehringer Ingelheim Investigational Site - San Diego

North Carolina

  • 1218.61.01007 Boehringer Ingelheim Investigational Site - Greensboro
  • 1218.61.01004 Boehringer Ingelheim Investigational Site - Jacksonville
  • 1218.61.01023 Boehringer Ingelheim Investigational Site - Wilmington

Georgia

  • 1218.61.01049 Boehringer Ingelheim Investigational Site - Lawrenceville
  • 1218.61.01008 Boehringer Ingelheim Investigational Site - Roswell

Illinois

  • 1218.61.01016 Boehringer Ingelheim Investigational Site - Chicago
  • 1218.61.01018 Boehringer Ingelheim Investigational Site - Chicago

Florida

  • 1218.61.01009 Boehringer Ingelheim Investigational Site - Miami

Idaho

  • 1218.61.01040 Boehringer Ingelheim Investigational Site - Meridian

Indiana

  • 1218.61.01048 Boehringer Ingelheim Investigational Site - Lafayette

Maine

  • 1218.61.01001 Boehringer Ingelheim Investigational Site - Auburn

Trial Details

FieldValue
Enrollment Target 278 participants
Start Date 2009-10
Phase Phase 3
Boehringer Ingelheim

515 total trials

What the finished NCT00996658 record still lists

NCT00996658 is an interventional study that assigns participants to a tested intervention. The registered 278 participants enrollment target is mid-sized for trials with a published cap, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (94% lower).

The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00996658 names 20 study sites across 11 states, led by California, North Carolina, Georgia.

Frequently Asked Questions

What is clinical trial NCT00996658 about?

NCT00996658 is a clinical study titled "Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone". The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add on therapy to metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with insufficient glycaemic con...

What is the current status of trial NCT00996658?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 278 participants. The study started on 2009-10.

What conditions does trial NCT00996658 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.

What interventions are being tested in trial NCT00996658?

The interventions under investigation include: Placebo (DRUG), Linagliptin (DRUG).

Who is sponsoring clinical trial NCT00996658?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00996658 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Diabetes Mellitus, Type 2

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00996658's enrollment target sits among peer trials

278 131st of 348 higher than 218 of 348 other Diabetes Mellitus, Type 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00996658, the US trial registry maintained by the National Library of Medicine. NCT00996658 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.