Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes

This study has been completed.

Sponsor:

Information provided by:

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00309608

First received: March 31, 2006

Last updated: May 18, 2012

Last verified: May 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 Drug: Glimepiride

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 1 mg	Patients randomized to receive treatment with Linagliptin 1 mg
Linagliptin 5 mg	Patients randomized to receive treatment with Linagliptin 5 mg
Linagliptin 10 mg	Patients randomized to receive treatment with Linagliptin 10 mg
Glimepiride	Patients randomized to receive treatment with Glimepiride

Participant Flow: Overall Study

	Placebo	Linagliptin 1 mg	Linagliptin 5 mg	Linagliptin 10 mg	Glimepiride
STARTED	71	65	66	66	65
COMPLETED	57	52	56	60	61
NOT COMPLETED	14	13	10	6	4
Adverse Event	1	5	3	2	3
Protocol Violation	2	0	0	0	0
Lost to Follow-up	0	0	2	0	1
Withdrawal by Subject	1	4	2	0	0
Other incl. Lack of efficacy	10	4	3	4	0

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Patients randomized to receive treatment with matching placebo
Linagliptin 1 mg	Patients randomized to receive treatment with Linagliptin 1 mg
Linagliptin 5 mg	Patients randomized to receive treatment with Linagliptin 5 mg
Linagliptin 10 mg	Patients randomized to receive treatment with Linagliptin 10 mg
Glimepiride	Patients randomized to receive treatment with Glimepiride
Total	Total of all reporting groups

Baseline Measures

	Placebo	Linagliptin 1 mg	Linagliptin 5 mg	Linagliptin 10 mg	Glimepiride	Total
Number of Participants [units: participants]	71	65	66	66	65	333
Age [units: Years] Mean ± Standard Deviation	60.1 ± 8.1	59.2 ± 8.4	59.6 ± 9.8	61.8 ± 8.8	59.4 ± 9.9	60.0 ± 9.0
Gender [units: participants]
Female	27	29	29	31	24	140
Male	44	36	37	35	41	193
Body Mass Index (BMI) continuous [units: kg/m^2] Mean ± Standard Deviation	32.2 ± 4.2	32.3 ± 4.3	31.7 ± 4.5	31.7 ± 4.5	31.5 ± 4.2	31.9 ± 4.3
Glycosylated Hemoglobin A1 (HbA1C) continuous [units: Percent] Mean ± Standard Deviation	8.37 ± 0.74	8.24 ± 0.74	8.46 ± 0.85	8.35 ± 0.73	8.22 ± 0.70	8.33 ± 0.75
Fasting plasma glucose (FPG) continuous [units: mg/dL] Mean ± Standard Deviation	185.5 ± 38.8	182.3 ± 42.0	189.3 ± 42.4	188.7 ± 42.4	179.9 ± 40.4	185.1 ± 41.0

Outcome Measures

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1. Primary:

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

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2. Secondary:

Percentage of Patients With HbA1c<=7.0% at Week 12 [ Time Frame: week 12 ]

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Measure Type	Secondary
Measure Title	Percentage of Patients With HbA1c<=7.0% at Week 12
Measure Description	Descriptive calculation of proportions on the basis of non-missing data
Time Frame	week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).

Reporting Groups

	Description
Placebo	Patients randomized to receive treatment with matching placebo
Linagliptin 1 mg	Patients randomized to receive treatment with Linagliptin 1 mg
Linagliptin 5 mg	Patients randomized to receive treatment with Linagliptin 5 mg
Linagliptin 10 mg	Patients randomized to receive treatment with Linagliptin 10 mg

Measured Values

	Placebo	Linagliptin 1 mg	Linagliptin 5 mg	Linagliptin 10 mg
Number of Participants Analyzed [units: participants]	70	64	62	66
Percentage of Patients With HbA1c<=7.0% at Week 12 [units: Percentage of Patients]	1.4	15.6	14.5	21.2

No statistical analysis provided for Percentage of Patients With HbA1c<=7.0% at Week 12

3. Secondary:

Fasting Blood Plasma Glucose Level (FPG) Change From Baseline at Week 12 [ Time Frame: Baseline and week 12 ]

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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:	NCT00309608 History of Changes
Other Study ID Numbers:	1218.6, 2005-004597-24
Study First Received:	March 31, 2006
Results First Received:	May 13, 2011
Last Updated:	May 18, 2012
Health Authority:	France: AFSSAPS Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte Great Britain: MHRA Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26 Sweden: Medical Products Agency Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)

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