Trial · NCT00954447

Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes

NCT00954447, Phase 3, Completed, Boehringer Ingelheim; results first posted 2012-09-27

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes. Trials, record NCT00954447. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00954447

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Trial

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

Title: Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes
NCT number: NCT00954447
Status: Completed
Phases: Phase 3
Enrollment: 1,263 participants, actual
Lead sponsor: Boehringer Ingelheim
Conditions: Diabetes Mellitus, Type 2
Interventions: Placebo, Linagliptin
First posted: 2009-08-07
Last updated: 2013-12-30
Other registries' IDs: eudract:2008-008296-33
Results first posted: 2012-09-27

Source ClinicalTrials.gov

Registered outcomes16

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in HbA1c After 24 Weeks	Baseline and 24 weeks	HbA1c is measured as a percentage. Adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant Oral antidiabetic drugs (OAD)
Secondary	Number of Patients With HbA1c < 7.0 Percent	24 and 52 weeks
Secondary	Number of Patients Lowering HbA1c by at Least 0.5 Percent	24 and 52 weeks
Secondary	Change From Baseline in HbA1c by Visit at Week 6	Baseline and 6 weeks	Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Secondary	Change From Baseline in HbA1c by Visit at Week 12	Baseline and 12 weeks	Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Secondary	Change From Baseline in HbA1c by Visit at Week 18	Baseline and 18 weeks	Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Secondary	Change From Baseline in HbA1c by Visit at Week 32	Baseline and 32 weeks	Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Secondary	Change From Baseline in HbA1c by Visit at Week 40	Baseline and 40 weeks	Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Secondary	Change From Baseline in HbA1c by Visit at Week 52	Baseline and 52 weeks	Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks of Treatment	Baseline and 24 weeks	Means adjusted for treatment, baseline HbA1c, baseline FPG, categorical renal function impairment and concomitant OADs

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in HbA1c After 24 Weeks	Baseline and 24 weeks	The Full Analysis Set (FAS) with a last observation carried forward (LOCF) approach. The FAS comprises all randomised patients who were treated with at least one dose of study medication, had a baseline HbA1c measurement, and had at least one on-treatment HbA1c measurement within the first 24 weeks of double-blind treatment.	Percentage	MEAN
SECONDARY	Number of Patients With HbA1c < 7.0 Percent	24 and 52 weeks	FAS using the non-completers considered failure (NCF) approach, in which missing data due to premature discontinuation of a patient were considered as failure.	Participants	NUMBER
SECONDARY	Number of Patients Lowering HbA1c by at Least 0.5 Percent	24 and 52 weeks	FAS (NCF)	Participants	NUMBER
SECONDARY	Change From Baseline in HbA1c by Visit at Week 6	Baseline and 6 weeks	FAS (LOCF)	Percentage	MEAN
SECONDARY	Change From Baseline in HbA1c by Visit at Week 12	Baseline and 12 weeks	FAS (LOCF)	Percentage	MEAN
SECONDARY	Change From Baseline in HbA1c by Visit at Week 18	Baseline and 18 weeks	FAS (LOCF)	Percentage	MEAN
SECONDARY	Change From Baseline in HbA1c by Visit at Week 32	Baseline and 32 weeks	FAS (LOCF)	Percentage	MEAN
SECONDARY	Change From Baseline in HbA1c by Visit at Week 40	Baseline and 40 weeks	FAS (LOCF)	Percentage	MEAN
SECONDARY	Change From Baseline in HbA1c by Visit at Week 52	Baseline and 52 weeks	FAS (LOCF)	Percentage	MEAN
SECONDARY	Change From Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks of Treatment	Baseline and 24 weeks	FAS (LOCF), further restricted to patients with a baseline FPG measurement and at least one on-treatment FPG measurement	mg/dL	MEAN

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group54

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

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in HbA1c After 24 Weeks	Placebo		0.07	Standard Error 0.08	Percentage
Change From Baseline in HbA1c After 24 Weeks	Linagliptin 5 mg		-0.58	Standard Error 0.08	Percentage
Number of Patients With HbA1c < 7.0 Percent	Placebo	after 24 weeks of treatment	56		Participants
Number of Patients With HbA1c < 7.0 Percent	Linagliptin 5 mg	after 24 weeks of treatment	134		Participants
Number of Patients With HbA1c < 7.0 Percent	Placebo	after 52 weeks of treatment	44		Participants
Number of Patients With HbA1c < 7.0 Percent	Linagliptin 5 mg	after 52 weeks of treatment	109		Participants
Number of Patients Lowering HbA1c by at Least 0.5 Percent	Placebo	after 24 weeks of treatment	137		Participants
Number of Patients Lowering HbA1c by at Least 0.5 Percent	Linagliptin 5 mg	after 24 weeks of treatment	333		Participants
Number of Patients Lowering HbA1c by at Least 0.5 Percent	Placebo	after 52 weeks of treatment	104		Participants
Number of Patients Lowering HbA1c by at Least 0.5 Percent	Linagliptin 5 mg	after 52 weeks of treatment	231		Participants

1 to 10 of 54Source ClinicalTrials.gov

See all 54 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	630
Overall Study	STARTED	Linagliptin 5 mg	631
Overall Study	COMPLETED	Placebo	520
Overall Study	COMPLETED	Linagliptin 5 mg	543
Overall Study	NOT COMPLETED	Placebo	110
Overall Study	NOT COMPLETED	Linagliptin 5 mg	88

Source ClinicalTrials.gov

Adverse events362

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	Placebo	30	630
other	Diarrhoea	Gastrointestinal disorders	Linagliptin 5 mg	33	631
other	Influenza	Infections and infestations	Placebo	33	630
other	Influenza	Infections and infestations	Linagliptin 5 mg	26	631
other	Nasopharyngitis	Infections and infestations	Placebo	62	630
other	Nasopharyngitis	Infections and infestations	Linagliptin 5 mg	71	631
other	Urinary tract infection	Infections and infestations	Placebo	43	630
other	Urinary tract infection	Infections and infestations	Linagliptin 5 mg	30	631
other	Hyperglycaemia	Metabolism and nutrition disorders	Placebo	112	630
other	Hyperglycaemia	Metabolism and nutrition disorders	Linagliptin 5 mg	90	631

1 to 10 of 362Source ClinicalTrials.gov

See all 362 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Linagliptin 5 mg
Total, other adverse events	Placebo	354	630
Total, other adverse events	Linagliptin 5 mg	354	631
Total, serious adverse events	Placebo	83	630
Total, serious adverse events	Linagliptin 5 mg	87	631

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
24062327	DERIVED	PubMed
25629790	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 5 mg vs Placebo: 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

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