Trial · NCT00622284

Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes

NCT00622284, Phase 3, Completed, Boehringer Ingelheim; results first posted 2012-02-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes. Trials, record NCT00622284. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00622284

On this page

Trial

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

Title: Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes
NCT number: NCT00622284
Status: Completed
Phases: Phase 3
Enrollment: 1,560 participants, actual
Lead sponsor: Boehringer Ingelheim
Conditions: Diabetes Mellitus, Type 2
Interventions: Placebo identical to BI 1356 5mg, Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg, BI 1356, Glimepiride
First posted: 2008-02-25
Last updated: 2014-01-29
Other registries' IDs: eudract:2007-004585-40
Results first posted: 2012-02-20
Limitations and caveats: With the exception of HbA1c\<6.5% and HbA1c\<7.0% at Week52, all other endpoints are presented in the Week52 repeated analysis within the final clinical trial report, where discrepancies between interim and final results are also explained.

Source ClinicalTrials.gov

Registered outcomes29

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

List	Outcome	Time frame	Description
Primary	HbA1c Change From Baseline at Week 52	Baseline and week 52	This co-primary endpoint, change from baseline, reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.
Primary	HbA1c Change From Baseline at Week 104	Baseline and week 104	This co-primary endpoint, change from baseline, reflects the Week 104 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.
Secondary	Body Weight Change From Baseline at Week 52	Baseline and week 52	This key secondary endpoint, change from baseline, reflects the Week 52 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications.
Secondary	Body Weight Change From Baseline at Week 104	Baseline and week 104	This key secondary endpoint, change from baseline, reflects the Week 104 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications.
Secondary	Incidence of Hypoglycaemic Events up to 52 Weeks	Week 52	A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a home blood glucose monitoring (HBGM) of below 55 mg/dl (3.1 mmol/L)
Secondary	Incidence of Hypoglycaemic Events up to 104 Weeks	Week 104	A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a HBGM of below 55 mg/dl (3.1 mmol/L)
Secondary	Fasting Plasma Glucose (FPG) Change From Baseline at Week 52	Baseline and week 52	This change from baseline reflects the Week 52 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and the number of previous anti-diabetic medications.
Secondary	Fasting Plasma Glucose (FPG) Change From Baseline at Week 104	Baseline and week 104	This change from baseline reflects the Week 104 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and number of previous anti-diabetic medications.
Secondary	Percentage of Patients With HbA1c <7.0% at Week 52	Week 52	The percentage of patients with an HbA1c value below 7.0% at week 52, based upon patients with baseline HbA1c \>= 7%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c \>= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.
Secondary	Percentage of Patients With HbA1c <7.0% at Week 104	Week 104	The percentage of patients with an HbA1c value below 7.0% at week 104, based upon patients with baseline HbA1c \>= 7%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c \>= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.

1 to 10 of 29Source ClinicalTrials.gov

See all 29 registered outcomes

Outcomes29

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	HbA1c Change From Baseline at Week 52	Baseline and week 52	The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.	Percent	MEAN
PRIMARY	HbA1c Change From Baseline at Week 104	Baseline and week 104	The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.	Percent	MEAN
SECONDARY	Body Weight Change From Baseline at Week 52	Baseline and week 52	This population includes the FAS further restricted to patients with a baseline body weight and one on-treatment body weight measurement. Last observation carried forward (LOCF) was used as imputation rule.	kg	MEAN
SECONDARY	Body Weight Change From Baseline at Week 104	Baseline and week 104	This population includes the FAS further restricted to patients with a baseline body weight and one on-treatment body weight measurement. Last observation carried forward (LOCF) was used as imputation rule.	kg	MEAN
SECONDARY	Incidence of Hypoglycaemic Events up to 52 Weeks	Week 52	The treated set consisted of all patients treated with at least one dose of study drug	Patients	NUMBER
SECONDARY	Incidence of Hypoglycaemic Events up to 104 Weeks	Week 104	The treated set consisted of all patients treated with at least one dose of study drug	Patients	NUMBER
SECONDARY	Fasting Plasma Glucose (FPG) Change From Baseline at Week 52	Baseline and week 52	This population includes the FAS further restricted to patients with a baseline FPG and one on-treatment FPG measurement. Last observation carried forward (LOCF) was used as imputation rule.	mg/dL	MEAN
SECONDARY	Fasting Plasma Glucose (FPG) Change From Baseline at Week 104	Baseline and week 104	This population includes the FAS further restricted to patients with a baseline FPG and one on-treatment FPG measurement. Last observation carried forward (LOCF) was used as imputation rule.	mg/dL	MEAN
SECONDARY	Percentage of Patients With HbA1c <7.0% at Week 52	Week 52	Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c \>=7.0%.	Percentage of patients	NUMBER
SECONDARY	Percentage of Patients With HbA1c <7.0% at Week 104	Week 104	Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c \>=7.0%.	Percentage of patients	NUMBER

1 to 10 of 29Source ClinicalTrials.gov

See all 29 outcomes

Results by group58

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

Outcome	Group	Value	Spread	Units
HbA1c Change From Baseline at Week 52	Linagliptin	-0.36	Standard Error 0.03	Percent
HbA1c Change From Baseline at Week 52	Glimepiride	-0.57	Standard Error 0.03	Percent
HbA1c Change From Baseline at Week 104	Linagliptin	-0.16	Standard Error 0.03	Percent
HbA1c Change From Baseline at Week 104	Glimepiride	-0.36	Standard Error 0.03	Percent
Body Weight Change From Baseline at Week 52	Linagliptin	-1.12	Standard Error 0.13	kg
Body Weight Change From Baseline at Week 52	Glimepiride	1.38	Standard Error 0.14	kg
Body Weight Change From Baseline at Week 104	Linagliptin	-1.39	Standard Error 0.16	kg
Body Weight Change From Baseline at Week 104	Glimepiride	1.29	Standard Error 0.16	kg
Incidence of Hypoglycaemic Events up to 52 Weeks	Linagliptin	41		Patients
Incidence of Hypoglycaemic Events up to 52 Weeks	Glimepiride	249		Patients

1 to 10 of 58Source ClinicalTrials.gov

See all 58 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Linagliptin	776
Overall Study	STARTED	Glimepiride	775
Overall Study	COMPLETED	Linagliptin	587
Overall Study	COMPLETED	Glimepiride	604
Overall Study	NOT COMPLETED	Linagliptin	189
Overall Study	NOT COMPLETED	Glimepiride	171

Source ClinicalTrials.gov

Adverse events566

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	Diarrhoea	Gastrointestinal disorders	Linagliptin	52	776
other	Diarrhoea	Gastrointestinal disorders	Glimepiride	60	775
other	Nausea	Gastrointestinal disorders	Linagliptin	37	776
other	Nausea	Gastrointestinal disorders	Glimepiride	39	775
other	Bronchitis	Infections and infestations	Linagliptin	50	776
other	Bronchitis	Infections and infestations	Glimepiride	60	775
other	Nasopharyngitis	Infections and infestations	Linagliptin	124	776
other	Nasopharyngitis	Infections and infestations	Glimepiride	125	775
other	Upper respiratory tract infection	Infections and infestations	Linagliptin	62	776
other	Upper respiratory tract infection	Infections and infestations	Glimepiride	59	775

1 to 10 of 566Source ClinicalTrials.gov

See all 566 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Linagliptin
Total, all-cause mortality	Glimepiride
Total, other adverse events	Linagliptin	438	776
Total, other adverse events	Glimepiride	526	775
Total, serious adverse events	Linagliptin	135	776
Total, serious adverse events	Glimepiride	162	775

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
22234149	DERIVED	PubMed
22748821	DERIVED	PubMed
23521323	DERIVED	PubMed
40020703	DERIVED	PubMed

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 comparisons1

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

Comparison
Linagliptin vs Glimepiride: serious adverse events

Source 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/NCT00622284

GET https://conductscience.org/api/trials/v1/NCT00622284/registered?page=2

API reference For AI assistants