Trial · NCT01703286

Trial to Assess the Influence of 4 Weeks' Treatment With Linagliptin as Compared to Glimepiride and Placebo on Endothelial Function in Patients With Type 2 Diabetes Using FMD (Flow-Mediated Vasodilation)

NCT01703286, Phase 1, Completed, Boehringer Ingelheim; results first posted 2015-01-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trial to Assess the Influence of 4 Weeks' Treatment With Linagliptin as Compared to Glimepiride and Placebo on Endothelial Function in Patients With Type 2 Diabetes Using FMD (Flow-Mediated Vasodilation). Trials, record NCT01703286. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01703286

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Trial

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

Title: Trial to Assess the Influence of 4 Weeks' Treatment With Linagliptin as Compared to Glimepiride and Placebo on Endothelial Function in Patients With Type 2 Diabetes Using FMD (Flow-Mediated Vasodilation)
NCT number: NCT01703286
Status: Completed
Phases: Phase 1
Enrollment: 42 participants, actual
Lead sponsor: Boehringer Ingelheim
Conditions: Diabetes Mellitus, Type 2
Interventions: Placebo, Linagliptin, Placebo, Placebo, Placebo, Glimepiride
First posted: 2012-10-10
Last updated: 2015-01-19
Other registries' IDs: eudract:2012-003317-33
Results first posted: 2015-01-19

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Flow Mediated Vasodilation (FMD) Under Fasted Condition on Day 28	baseline and day 28 for each treatment arm	Endothelial function under fasted condition was measured with flow mediated vasodilation (FMD). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.
Secondary	Change From Baseline in Flow Mediated Vasodilation (FMD) 2 h Post Meal on Day 28	baseline and day 28 for each treatment arm	Endothelial function 2 hours post meal was measured with flow mediated vasodilation (FMD). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.
Secondary	Change From Baseline in 2 Hours Post Meal Endothelial Independent Vasodilation (EIDV) on Day 28	baseline and day 28 for each treatment arm	Endothelial function 2h post-meal was measured by endothelial independent vasodilation (EIDV). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.
Secondary	Number of Patients With Adverse Events	up to 20 weeks	Number of patients with any adverse events

Source ClinicalTrials.gov

Outcomes4

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 Flow Mediated Vasodilation (FMD) Under Fasted Condition on Day 28	baseline and day 28 for each treatment arm	Efficacy set (ES)- included all patients of the TS who provided at least 1 observation for at least 1 primary, secondary, or other efficacy endpoint without important protocol violations relevant for the statistical evaluation of these endpoints.	percentage	GEOMETRIC_MEAN
SECONDARY	Change From Baseline in Flow Mediated Vasodilation (FMD) 2 h Post Meal on Day 28	baseline and day 28 for each treatment arm		Percentage	GEOMETRIC_MEAN
SECONDARY	Change From Baseline in 2 Hours Post Meal Endothelial Independent Vasodilation (EIDV) on Day 28	baseline and day 28 for each treatment arm	Efficacy set (ES)- included all patients of the TS who provided at least 1 observation for at least 1 primary, secondary, or other efficacy endpoint without important protocol violations relevant for the statistical evaluation of these endpoints.	percentage	MEAN
SECONDARY	Number of Patients With Adverse Events	up to 20 weeks	Treated set (TS)	participants	NUMBER

Source ClinicalTrials.gov

Results by group15

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

Outcome	Group	Value	Spread	Units
Change From Baseline in Flow Mediated Vasodilation (FMD) Under Fasted Condition on Day 28	Linagliptin 5 mg	0.885	90% Confidence Interval 0.695 to 1.128	percentage
Change From Baseline in Flow Mediated Vasodilation (FMD) Under Fasted Condition on Day 28	Glimepiride 1-4 mg	1.002	90% Confidence Interval 0.795 to 1.262	percentage
Change From Baseline in Flow Mediated Vasodilation (FMD) Under Fasted Condition on Day 28	Placebo	1.002	90% Confidence Interval 0.786 to 1.277	percentage
Change From Baseline in Flow Mediated Vasodilation (FMD) 2 h Post Meal on Day 28	Linagliptin 5 mg	1.262	90% Confidence Interval 0.968 to 1.646	Percentage
Change From Baseline in Flow Mediated Vasodilation (FMD) 2 h Post Meal on Day 28	Glimepiride 1-4 mg	1.045	90% Confidence Interval 0.815 to 1.339	Percentage
Change From Baseline in Flow Mediated Vasodilation (FMD) 2 h Post Meal on Day 28	Placebo	1.009	90% Confidence Interval 0.777 to 1.311	Percentage
Change From Baseline in 2 Hours Post Meal Endothelial Independent Vasodilation (EIDV) on Day 28	Linagliptin 5 mg	1.003	90% Confidence Interval 0.945 to 1.061	percentage
Change From Baseline in 2 Hours Post Meal Endothelial Independent Vasodilation (EIDV) on Day 28	Glimepiride 1-4 mg	1.053	90% Confidence Interval 0.998 to 1.108	percentage
Change From Baseline in 2 Hours Post Meal Endothelial Independent Vasodilation (EIDV) on Day 28	Placebo	0.981	90% Confidence Interval 0.923 to 1.039	percentage
Number of Patients With Adverse Events	Linagliptin 5 mg	11		participants

1 to 10 of 15Source ClinicalTrials.gov

See all 15 results by group

Participant flow54

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

Period	Milestone	Group	Participants
Period 1 Including Washout	STARTED	Pbo/ G1-4/ L 5	7
Period 1 Including Washout	STARTED	L 5/ G 1-4/ Pbo	7
Period 1 Including Washout	STARTED	G 1-4/ L 5/ Pbo	7
Period 1 Including Washout	STARTED	G1-4/ Pbo/ L 5	7
Period 1 Including Washout	STARTED	Pbo/ L 5/ G1-4	7
Period 1 Including Washout	STARTED	L 5/ Pbo/ G1-4/	7
Period 1 Including Washout	COMPLETED	Pbo/ G1-4/ L 5	7
Period 1 Including Washout	COMPLETED	L 5/ G 1-4/ Pbo	7
Period 1 Including Washout	COMPLETED	G 1-4/ L 5/ Pbo	7
Period 1 Including Washout	COMPLETED	G1-4/ Pbo/ L 5	6

1 to 10 of 54Source ClinicalTrials.gov

See all 54 participant flow

Adverse events12

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	Linagliptin 5 mg	1	40
other	Nasopharyngitis	Infections and infestations	Glimepiride 1-4 mg	6	41
other	Nasopharyngitis	Infections and infestations	Placebo	3	40
other	Hypoglycaemia	Metabolism and nutrition disorders	Linagliptin 5 mg	2	40
other	Hypoglycaemia	Metabolism and nutrition disorders	Glimepiride 1-4 mg	16	41
other	Hypoglycaemia	Metabolism and nutrition disorders	Placebo	1	40
other	Headache	Nervous system disorders	Linagliptin 5 mg	4	40
other	Headache	Nervous system disorders	Glimepiride 1-4 mg	3	41
other	Headache	Nervous system disorders	Placebo	6	40
other	Hyperhidrosis	Skin and subcutaneous tissue disorders	Linagliptin 5 mg	0	40

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Linagliptin 5 mg
Total, all-cause mortality	Glimepiride 1-4 mg
Total, all-cause mortality	Placebo
Total, other adverse events	Linagliptin 5 mg	6	40
Total, other adverse events	Glimepiride 1-4 mg	20	41
Total, other adverse events	Placebo	9	40
Total, serious adverse events	Linagliptin 5 mg	0	40
Total, serious adverse events	Glimepiride 1-4 mg	0	41
Total, serious adverse events	Placebo	0	40

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28109295	DERIVED

Source 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 comparisons0

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

None in this release.

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.

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