Randomized, Double-blind (db), Placebo-controlled 18 Week Study of Linagliptin (BI 1356) in Type 2 Diabetic Patients With Insufficient Glycaemic Control on a Sulfonylurea Drug

This study has been completed.

Sponsor:

Information provided by:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT00819091

First received: January 7, 2009

Last updated: June 17, 2014

Last verified: December 2013

History of Changes

Results First Received: May 13, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
Condition:	Diabetes Mellitus, Type 2
Interventions:	Drug: BI 1356 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	Matching placebo tablet taken orally once daily
Linagliptin (BI 1356) 5.0 mg	Linagliptin 5.0 mg tablet taken orally once daily

Participant Flow: Overall Study

	Placebo	Linagliptin (BI 1356) 5.0 mg
STARTED	84	161
COMPLETED	77	151
NOT COMPLETED	7	10
Adverse Event	3	5
Protocol Violation	0	1
Lost to Follow-up	2	0
Withdrawal by Subject	1	2
Not Specified	1	2

Baseline Characteristics

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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.
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Reporting Groups

	Description
Placebo	Matching placebo tablet taken orally once daily
Linagliptin 5.0 mg	Linagliptin 5.0 mg tablet taken orally once daily
Total	Total of all reporting groups

Baseline Measures

	Placebo	Linagliptin 5.0 mg	Total
Overall Participants Analyzed [Units: Participants]	84	161	245

Age [Units: Years] Mean (Standard Deviation)	56.2 (10.2)	57.2 (9.8)	56.9 (9.9)

Gender [Units: Participants]
Female	32	84	116
Male	52	77	129

Race/Ethnicity, Customized [Units: Participants]
White	34	73	107
Black	6	11	17
Asian	43	76	119
American Indian/Alaskan Native	1	1	2

Race/Ethnicity, Customized [Units: Participants]
Not Hispanic	70	133	203
Hispanic	14	28	42

Body Mass Index (BMI) [Units: Kilogram/square meter] Mean (Standard Deviation)	28.21 (5.12)	28.40 (5.02)	28.33 (5.04)

Baseline glycosylated hemoglobin (HbA1c) [Units: Percentage] Mean (Standard Deviation)	8.6 (0.72)	8.61 (0.85)	8.61 (0.81)

Fasting blood plasma glucose (FPG) [Units: Milligram/deciliter (mg/dL)] Mean (Standard Deviation)	174.9 (49.0)	182.0 (51.8)	179.6 (50.9)

Outcome Measures

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1. Primary:

Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18 [ Time Frame: Baseline, week 18 ]

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2. Secondary:

Change From Baseline in Fasting Plasma Glucose at Week 18 [ Time Frame: Baseline, week 18 ]

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3. Secondary:

Percentage of Patients With Absolute Efficacy Response (HbA1c < 7%) at Week 18 [ Time Frame: week 18 ]

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4. Secondary:

Percentage of Patients With Absolute Efficacy Response (HbA1c < 6.5%) at Week 18 [ Time Frame: week 18 ]

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5. Secondary:

Percentage of Patients With HbA1c Lowering by at Least 0.5% From Baseline at Week 18 [ Time Frame: Baseline, week 18 ]

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6. Secondary:

Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 6 [ Time Frame: Baseline, week 6 ]

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7. Secondary:

Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 12 [ Time Frame: Baseline, week 12 ]

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8. Secondary:

Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 18 [ Time Frame: Baseline, week 18 ]

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9. Secondary:

Change From Baseline in Fasting Plasma Glucose at Week 6 [ Time Frame: Baseline, week 6 ]

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10. Secondary:

Change From Baseline in Fasting Plasma Glucose at Week 12 [ Time Frame: Baseline, week 12 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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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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.

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

McGill JB, Barnett AH, Lewin AJ, Patel S, Neubacher D, von Eynatten M, Woerle HJ. Linagliptin added to sulphonylurea in uncontrolled type 2 diabetes patients with moderate-to-severe renal impairment. Diab Vasc Dis Res. 2014 Jan;11(1):34-40. doi: 10.1177/1479164113507068. Epub 2013 Oct 29.

Lewin AJ, Arvay L, Liu D, Patel S, von Eynatten M, Woerle HJ. Efficacy and tolerability of linagliptin added to a sulfonylurea regimen in patients with inadequately controlled type 2 diabetes mellitus: an 18-week, multicenter, randomized, double-blind, placebo-controlled trial. Clin Ther. 2012 Sep;34(9):1909-19.e15. doi: 10.1016/j.clinthera.2012.07.008. Epub 2012 Aug 29.

Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol. 2012 Jan 10;11:3. doi: 10.1186/1475-2840-11-3.

Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00819091 History of Changes
Other Study ID Numbers:	1218.35 2008-003118-86 ( EudraCT Number: EudraCT )
Study First Received:	January 7, 2009
Results First Received:	May 13, 2011
Last Updated:	June 17, 2014

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