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Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Phase III, Randomised, Double Blind, Placebo Controlled Parallel Group Efficacy and Safety Study of Linagliptin 5 mg Administered Orally Once Daily Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite a Therapy of Metformin in Combination With Pioglitazone

NCT00996658•Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 79 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diagnosis of diabetes mellitus prior to informed consent
•2. Patients treated with metformin and pioglitazone (therapy should be unchanged for 12 weeks)
•3. Glycosylated haemoglobin A1 \>= 7.5% and \<= 10%
•4. Age between 18 and less than 80
•5. \- Body Mass index less or equal to 45

Exclusion Criteria

•1. Uncontrolled hyperglycaemia during run in period
•2. Myocardial infarction, stroke or transient ischaemic accident within 3 months prior to informed consent
•3. Impaired hepatic function
•4. Gastric by pass surgery
•5. Treatment with roziglitazone, GLP 1 analogues, DPP-4 inhibitors or insulin within 3 months prior to informed consent
•6. Treatment with anti-obesity drugs
•7. Current treatment with systemic steroids at the time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
•8. Premenopausal women who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control or do not plan to continue using this method during the trial

Locations (52)

1218.61.01028 Boehringer Ingelheim Investigational Site

Escondido, California, United States

1218.61.01014 Boehringer Ingelheim Investigational Site

Greenbrae, California, United States

1218.61.01015 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

1218.61.01042 Boehringer Ingelheim Investigational Site

Paramount, California, United States

1218.61.01046 Boehringer Ingelheim Investigational Site

Poway, California, United States

1218.61.01044 Boehringer Ingelheim Investigational Site

San Diego, California, United States

1218.61.01009 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

1218.61.01049 Boehringer Ingelheim Investigational Site

Lawrenceville, Georgia, United States

1218.61.01008 Boehringer Ingelheim Investigational Site

Roswell, Georgia, United States

1218.61.01040 Boehringer Ingelheim Investigational Site

Meridian, Idaho, United States

Key Dates

Start Date

October 1, 2009

Primary Completion Date

March 1, 2012

Last Updated

March 26, 2014

Enrollment

278

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

Placebo

DRUG

Linagliptin

DRUG

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NCT06959901

Obesity and Diabetes Mellitus, Type 2Diabetes Prevention

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RECRUITINGNA

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NCT06574035

Diabetes Mellitus, Type 2Depressive Symptoms+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 26, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

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