Efficacy and Safety of BI 1356 (Linagliptin) Versus Placebo in Type 2 Diabetic Patients With Insufficient Glycemic Control

This study has been completed.

Study NCT00621140 Information provided by Boehringer Ingelheim Pharmaceuticals

First Received on January 14, 2008. Last Updated on May 18, 2012 History of Changes

Results First Received: May 13, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double-Blind; Primary Purpose: Treatment
Condition:	Diabetes Mellitus, Type 2
Interventions:	Drug: linagliptin Drug: placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	Patients randomized to receive treatment with matching placebo
Linagliptin	Patients randomized to receive treatment with Linagliptin 5mg

Participant Flow: Overall Study

	Placebo	Linagliptin
STARTED	167 ^[1]	336 ^[1]
COMPLETED	152 ^[2]	318 ^[2]
NOT COMPLETED	15	18
Adverse Event	4	5
Lost to Follow-up	1	2
Withdrawal by Subject	4	6
Other incl. lack of efficacy	6	5

[1]	number who started treatment
[2]	number who completed treatment

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Patients randomized to receive treatment with matching placebo
Linagliptin	Patients randomized to receive treatment with Linagliptin 5mg

Baseline Measures

	Placebo	Linagliptin	Total
Number of Participants [units: participants]	167	336	503
Age [units: Years] Mean ± Standard Deviation	54.4 ± 10.3	56.4 ± 10.1	55.7 ± 10.2
Gender [units: Patients]
Female	88	172	260
Male	79	164	243
Body Mass Index (BMI) continuous [units: kg/m^2] Mean ± Standard Deviation	29.08 ± 4.84	29.04 ± 4.80	29.05 ± 4.81
Glycosylated Hemoglobin A1 (HbA1C) [units: Percent] Mean ± Standard Deviation	8.00 ± 0.86	8.00 ± 0.87	8.00 ± 0.67
Fasting plasma glucose (FPG) [units: mg/dL] Mean ± Standard Deviation	168.7 ± 39.3	164.7 ± 41.9	166.0 ± 41.1

Outcome Measures

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1. Primary:

HbA1c Change From Baseline at Week 24 [ Time Frame: Baseline and week 24 ]

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2. Secondary:

HbA1c Change From Baseline at Week 6 [ Time Frame: Baseline and week 6 ]

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3. Secondary:

HbA1c Change From Baseline at Week 12 [ Time Frame: Baseline and week 12 ]

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4. Secondary:

HbA1c Change From Baseline at Week 18 [ Time Frame: Baseline and week 18 ]

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5. Secondary:

FPG Change From Baseline at Week 24 [ Time Frame: Baseline and week 24 ]

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6. Secondary:

FPG Change From Baseline at Week 6 [ Time Frame: Baseline and week 6 ]

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7. Secondary:

FPG Change From Baseline at Week 12 [ Time Frame: Baseline and week 12 ]

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8. Secondary:

FPG Change From Baseline at Week 18 [ Time Frame: Baseline and week 18 ]

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9. Secondary:

Percentage of Patients With HbA1c <7.0% at Week 24 [ Time Frame: Baseline and week 24 ]

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10. Secondary:

Percentage of Patients With HbA1c<7.0% at Week 24 [ Time Frame: Baseline and week 24 ]

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11. Secondary:

Percentage of Patients With HbA1c <6.5% at Week 24 [ Time Frame: Baseline and week 24 ]

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12. Secondary:

Percentage of Patients With HbA1c<6.5% at Week 24 [ Time Frame: Baseline and week 24 ]

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13. Secondary:

Percentage of Patients With HbA1c Lowering by 0.5% at Week 24 [ Time Frame: Baseline and week 24 ]

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14. Secondary:

Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at Week 24 [ Time Frame: Baseline and week 24 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com

No publications provided

Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00621140 History of Changes
Other Study ID Numbers:	1218.16, 2007-002448-10
Study First Received:	January 14, 2008
Results First Received:	May 13, 2011
Last Updated:	May 18, 2012
Health Authority:	Croatia: Croatian Institute for Medicines Control, HR-10000 Zagreb India: Drug Control General of India Israel: No regulatory agency approval needed for clinical trials Italy: Comitato Etico per la sperim. clinica dei medicinali dell'A.O. Universitaria Pisana di Pisa Malaysia: Ministry of Health, Malaysia Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Poland: Urzad Rejestracji Produktow Leczniczych, Wyrobow, Medycznych i Produktow Biobojczych, PL-00725 Warsaw Romania: National Medicines Agency, Bucharest Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26 Thailand: Ministry of Public Health Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine) United States: Food and Drug Administration