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

NCT ID: NCT00996658

Last Updated: 2014-03-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Linagliptin

Linagliptin tablets once daily

Group Type EXPERIMENTAL

Linagliptin

Intervention Type DRUG

Linagliptin tablets once daily

Placebo

Placebo tablets once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matching linagliptin tablets once daily

Interventions

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Placebo

Placebo matching linagliptin tablets once daily

Intervention Type DRUG

Linagliptin

Linagliptin tablets once daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1218.61.01028 Boehringer Ingelheim Investigational Site

Escondido, California, United States

Site Status

1218.61.01014 Boehringer Ingelheim Investigational Site

Greenbrae, California, United States

Site Status

1218.61.01015 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

1218.61.01042 Boehringer Ingelheim Investigational Site

Paramount, California, United States

Site Status

1218.61.01046 Boehringer Ingelheim Investigational Site

Poway, California, United States

Site Status

1218.61.01044 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Site Status

1218.61.01009 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Site Status

1218.61.01049 Boehringer Ingelheim Investigational Site

Lawrenceville, Georgia, United States

Site Status

1218.61.01008 Boehringer Ingelheim Investigational Site

Roswell, Georgia, United States

Site Status

1218.61.01040 Boehringer Ingelheim Investigational Site

Meridian, Idaho, United States

Site Status

1218.61.01016 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Site Status

1218.61.01018 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Site Status

1218.61.01048 Boehringer Ingelheim Investigational Site

Lafayette, Indiana, United States

Site Status

1218.61.01001 Boehringer Ingelheim Investigational Site

Auburn, Maine, United States

Site Status

1218.61.01043 Boehringer Ingelheim Investigational Site

Olive Branch, Mississippi, United States

Site Status

1218.61.01052 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

Site Status

1218.61.01030 Boehringer Ingelheim Investigational Site

New York, New York, United States

Site Status

1218.61.01007 Boehringer Ingelheim Investigational Site

Greensboro, North Carolina, United States

Site Status

1218.61.01004 Boehringer Ingelheim Investigational Site

Jacksonville, North Carolina, United States

Site Status

1218.61.01023 Boehringer Ingelheim Investigational Site

Wilmington, North Carolina, United States

Site Status

1218.61.01027 Boehringer Ingelheim Investigational Site

Perrysburg, Ohio, United States

Site Status

1218.61.01031 Boehringer Ingelheim Investigational Site

East Providence, Rhode Island, United States

Site Status

1218.61.01017 Boehringer Ingelheim Investigational Site

Simpsonville, South Carolina, United States

Site Status

1218.61.01005 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Site Status

1218.61.01006 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

1218.61.01053 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

1218.61.01003 Boehringer Ingelheim Investigational Site

Sugar Land, Texas, United States

Site Status

1218.61.01024 Boehringer Ingelheim Investigational Site

Bennington, Vermont, United States

Site Status

1218.61.01020 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Site Status

1218.61.3301A Boehringer Ingelheim Investigational Site

Besançon, , France

Site Status

1218.61.3306A Boehringer Ingelheim Investigational Site

Béziers, , France

Site Status

1218.61.3311A Boehringer Ingelheim Investigational Site

Béziers, , France

Site Status

1218.61.3309A Boehringer Ingelheim Investigational Site

Bourg Des Cptes, , France

Site Status

1218.61.3310A Boehringer Ingelheim Investigational Site

Cournonterral, , France

Site Status

1218.61.3312A Boehringer Ingelheim Investigational Site

Laval, , France

Site Status

1218.61.3313A Boehringer Ingelheim Investigational Site

Louvigné-de-Bais, , France

Site Status

1218.61.3305A Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1218.61.3307A Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1218.61.91002 Boehringer Ingelheim Investigational Site

Bangalore, , India

Site Status

1218.61.91003 Boehringer Ingelheim Investigational Site

Bangalore, , India

Site Status

1218.61.91004 Boehringer Ingelheim Investigational Site

Bangalore, , India

Site Status

1218.61.91008 Boehringer Ingelheim Investigational Site

Hyderabad, , India

Site Status

1218.61.91009 Boehringer Ingelheim Investigational Site

Jaipur, , India

Site Status

1218.61.91010 Boehringer Ingelheim Investigational Site

Karnataka, , India

Site Status

1218.61.91001 Boehringer Ingelheim Investigational Site

Maharashtra, , India

Site Status

1218.61.91006 Boehringer Ingelheim Investigational Site

Maharashtra, , India

Site Status

1218.61.91011 Boehringer Ingelheim Investigational Site

Maharashtra, , India

Site Status

1218.61.91005 Boehringer Ingelheim Investigational Site

Mumbai, , India

Site Status

1218.61.91007 Boehringer Ingelheim Investigational Site

Mumbai, , India

Site Status

1218.61.63003 Boehringer Ingelheim Investigational Site

Cebu City, , Philippines

Site Status

1218.61.63004 Boehringer Ingelheim Investigational Site

Cebu City, , Philippines

Site Status

1218.61.63002 Boehringer Ingelheim Investigational Site

Davao City, , Philippines

Site Status

Countries

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United States France India Philippines

References

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Bajaj M, Gilman R, Patel S, Kempthorne-Rawson J, Lewis-D'Agostino D, Woerle HJ. Linagliptin improved glycaemic control without weight gain or hypoglycaemia in patients with type 2 diabetes inadequately controlled by a combination of metformin and pioglitazone: a 24-week randomized, double-blind study. Diabet Med. 2014 Dec;31(12):1505-14. doi: 10.1111/dme.12495. Epub 2014 Jul 7.

Reference Type DERIVED
PMID: 24824197 (View on PubMed)

Other Identifiers

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2009-013289-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1218.61

Identifier Type: -

Identifier Source: org_study_id

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