Trial · NCT00736099

Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM

NCT00736099, Phase 3, Completed, Boehringer Ingelheim; results first posted 2012-03-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM. Trials, record NCT00736099. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00736099

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM
NCT number: NCT00736099
Status: Completed
Phases: Phase 3
Enrollment: 2,122 participants, actual
Lead sponsor: Boehringer Ingelheim
Conditions: Diabetes Mellitus, Type 2
Interventions: linagliptine 5 mg, linagliptine 5 mg and pioglitazone 30 mg
First posted: 2008-08-15
Last updated: 2014-06-27
Other registries' IDs: eudract:2008-000750-13
Results first posted: 2012-03-08

Source ClinicalTrials.gov

Registered outcomes46

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Frequency of Patients With Adverse Events (AEs)	78 weeks	This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.
Primary	Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events	78 weeks
Primary	Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ)	78 weeks	As significant adverse events are considered: renal Aes (SMQ 'acute renal failure'), hypersensitivity reactions ('anaphylactic reactions' and 'angioedema'), hepatic Aes ('hepatitis, non-infectious', 'hepatic failure, fibrosis, cirrhosis and other liver damage-related conditions', 'liver-related investigations, signs and symptoms', 'cholestasis and jaundice of hepatic origin'), severe cutaneous adverse reactions ('severe cutaneous adverse reaction'), pancreatitis ('acute pancreatitis', 'chronic pancreatitis'').
Primary	Frequency of Patients With Adjudication of Cardiac and Cerebrovascular Events	78 weeks	Patients reported with cardiac and cerebrovascular events qualified for adjudication by the Clinical Event Committee (CEC)
Primary	Number of Patients With Abnormalities in Vital Signs	78 weeks	Vital sign abnormalities (any abnormalities found during PE or ECG are reported with adverse events)
Primary	Number of Patients With Abnormalities in Haematology: Eosinophils	78 weeks	For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 10%.
Primary	Number of Patients With Abnormalities in Haematology: Haemoglobin	78 weeks	For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 11.5 g/dL for male and as a value less than or equal to 9.5 g/dL for female patients.
Primary	Number of Patients With Abnormalities in Haematology: Haematocrit	78 weeks	For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 32%.
Primary	Number of Patients With Abnormalities in Haematology: Red Blood Cell Count	78 weeks	For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 \* 10\^12/L.
Primary	Number of Patients With Abnormalities in Haematology: White Blood Cell Count	78 weeks	For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 \* 10\^9/L (decrease) or a value greater than 20.1 \* 10\^9/L (increase).

1 to 10 of 46Source ClinicalTrials.gov

See all 46 registered outcomes

Outcomes46

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Frequency of Patients With Adverse Events (AEs)	78 weeks	Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.	Participants	NUMBER
PRIMARY	Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events	78 weeks	Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.	Participants	NUMBER
PRIMARY	Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ)	78 weeks	Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.	Participants	NUMBER
PRIMARY	Frequency of Patients With Adjudication of Cardiac and Cerebrovascular Events	78 weeks	Treated Set: all screened patients who were documented to have taken at least 1 dose of study drug	participants	NUMBER
PRIMARY	Number of Patients With Abnormalities in Vital Signs	78 weeks	Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.	Participants	NUMBER
PRIMARY	Number of Patients With Abnormalities in Haematology: Eosinophils	78 weeks	Treated Set with values for Eosinophils	participants	NUMBER
PRIMARY	Number of Patients With Abnormalities in Haematology: Haemoglobin	78 weeks	Treated Set with values for Haemoglobin	Participants	NUMBER
PRIMARY	Number of Patients With Abnormalities in Haematology: Haematocrit	78 weeks	Treated Set with values for Haematocrit	Participants	NUMBER
PRIMARY	Number of Patients With Abnormalities in Haematology: Red Blood Cell Count	78 weeks	Treated Set with values for Red blood cell count	Participants	NUMBER
PRIMARY	Number of Patients With Abnormalities in Haematology: White Blood Cell Count	78 weeks	Treated Set with values for White blood cell count	Participants	NUMBER

1 to 10 of 46Source ClinicalTrials.gov

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Results by group116

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Frequency of Patients With Adverse Events (AEs)	Old Lina	Patients with any AEs	1253	Participants
Frequency of Patients With Adverse Events (AEs)	New Lina	Patients with any AEs	465	Participants
Frequency of Patients With Adverse Events (AEs)	Old Lina	Patients with severe AEs	57	Participants
Frequency of Patients With Adverse Events (AEs)	New Lina	Patients with severe AEs	23	Participants
Frequency of Patients With Adverse Events (AEs)	Old Lina	Patients with withdrawal due to AEs (from AE page)	57	Participants
Frequency of Patients With Adverse Events (AEs)	New Lina	Patients with withdrawal due to AEs (from AE page)	16	Participants
Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events	Old Lina		209	Participants
Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events	New Lina		86	Participants
Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ)	Old Lina	Renal AEs	20	Participants
Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ)	New Lina	Renal AEs	10	Participants

1 to 10 of 116Source ClinicalTrials.gov

See all 116 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Old Lina	1,532
Overall Study	STARTED	New Lina	589
Overall Study	COMPLETED	Old Lina	1,349
Overall Study	COMPLETED	New Lina	531
Overall Study	NOT COMPLETED	Old Lina	183
Overall Study	NOT COMPLETED	New Lina	58

Source ClinicalTrials.gov

Adverse events408

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nasopharyngitis	Infections and infestations	Old Lina	164	1,532
other	Nasopharyngitis	Infections and infestations	New Lina	62	589
other	Upper respiratory tract infection	Infections and infestations	Old Lina	122	1,532
other	Upper respiratory tract infection	Infections and infestations	New Lina	54	589
other	Urinary tract infection	Infections and infestations	Old Lina	74	1,532
other	Urinary tract infection	Infections and infestations	New Lina	33	589
other	Hyperglycaemia	Metabolism and nutrition disorders	Old Lina	376	1,532
other	Hyperglycaemia	Metabolism and nutrition disorders	New Lina	121	589
other	Hypoglycaemia	Metabolism and nutrition disorders	Old Lina	200	1,532
other	Hypoglycaemia	Metabolism and nutrition disorders	New Lina	85	589

1 to 10 of 408Source ClinicalTrials.gov

See all 408 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Old Lina
Total, all-cause mortality	New Lina
Total, other adverse events	Old Lina	784	1,532
Total, other adverse events	New Lina	285	589
Total, serious adverse events	Old Lina	158	1,532
Total, serious adverse events	New Lina	52	589

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons25

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Old Lina vs New Lina: Number of Patients With Abnormalities in Clinical Chemistry: Uric Acid	Trial comparisons
Old Lina vs New Lina: Number of Patients With Abnormalities in Clinical Chemistry: Aspartate Transaminase (AST)	Trial comparisons
Old Lina vs New Lina: Number of Patients With Abnormalities in Haematology: Red Blood Cell Count	Trial comparisons
Old Lina vs New Lina: Number of Patients With Abnormalities in Haematology: Haematocrit	Trial comparisons
Old Lina vs New Lina: Number of Patients With HbA1c<6.5% Over Time	Trial comparisons
Old Lina vs New Lina: Number of Patients With Abnormalities in Clinical Chemistry: Albumin	Trial comparisons
Old Lina vs New Lina: Number of Patients With HbA1c<7.0% Over Time	Trial comparisons
Old Lina vs New Lina: Number of Patients With Lowered HbA1c by at Least 0.5% Over Time	Trial comparisons
Old Lina vs New Lina: Number of Patients With Abnormalities in Vital Signs	Trial comparisons
Old Lina vs New Lina: Number of Patients With Abnormalities in Clinical Chemistry: Lactate Dehydrogenase (LDH)	Trial comparisons

1 to 10 of 25

See all 25 trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00736099

GET https://conductscience.org/api/trials/v1/NCT00736099/registered?page=2

API reference For AI assistants