NCT00716092

Brief Summary

The objective of this study is to investigate the effect of BI 1356 on 24-h glucose control and various pharmacodynamic parameters in type 2 diabetic patients with inadequate glycaemic control.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for phase_2 diabetes-mellitus-type-2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

June 15, 2011

Completed
Last Updated

June 27, 2014

Status Verified

January 1, 2014

Enrollment Period

4 months

First QC Date

July 15, 2008

Results QC Date

May 13, 2011

Last Update Submit

June 18, 2014

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

  • Weighted Mean Glucose (WMG) Change From Baseline at Day 28

    The change from baseline reflects the day 28 WMG value minus the baseline WMG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication, and baseline WMG.

    Baseline and day 28

  • GLP-1 (Glucagon Like Peptide 1) AUEC (0-2h) (Area Under Effect Curve) Change From Baseline at Day 28

    The change from baseline reflects the day 28 GLP-1 AUEC (0-2h) value minus the baseline GLP-1 AUEC (0-2h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline GLP-1.

    Baseline and day 28

Secondary Outcomes (2)

  • Fasting Plasma Glucose (FPG) Change From Baseline at Day 28

    Baseline and day 28

  • Plasma Glucose Area Under Effect Curve (AUEC) (0-3h) Change From Baseline at Day 28

    Baseline and day 28

Other Outcomes (4)

  • Exploratory Sensitivity Analysis of the WMG Change From Baseline at Day 28

    Baseline and day 28

  • Exploratory Sensitivity Analysis of GLP-1 AUEC (0-2h) Change From Baseline at Day 28

    Baseline and day 28

  • Exploratory Sensitivity Analysis of FPG Change From Baseline at Day 28

    Baseline and day 28

  • +1 more other outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Patients received placebo matching 5mg linagliptin and placebo matching 100mg sitagliptin.

Drug: Placebo (linagliptin)Drug: Placebo (sitagliptin)

Linagliptin

EXPERIMENTAL

Patients received 5mg linagliptin, and placebo matching 100mg sitagliptin.

Drug: Placebo (sitagliptin)Drug: Linagliptin

Sitagliptin

ACTIVE COMPARATOR

Patients received 100mg sitagliptin, and placebo matching 5mg linagliptin.

Drug: Placebo (linagliptin)Drug: Sitagliptin

Interventions

Placebo (linagliptin)DRUG

once daily for 28 days

Sitagliptin
SitagliptinDRUG

100 mg once daily for 28 days

Sitagliptin
Placebo (sitagliptin)DRUG

once daily for 28 days

Linagliptin
LinagliptinDRUG

5mg once daily for 28 days

Linagliptin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with not more than one drug
  • Glycosylated haemoglobin A1 (HbA1c) 6.5 to 10.0% at Start of Run-in

You may not qualify if:

  • Myocardial infarction, stroke or transient ischemic attack "TIA" within 6 months prior to informed consent
  • Impaired hepatic function
  • Renal insufficiency with a creatinine clearance \< 50 mL/min
  • Treatment with rosiglitazone, pioglitazone, glucagon like peptide 1 (GLP-1) analogues, insulin, dipeptidyl peptidase 4 (DPP-4) inhibitors or anti-obesity drugs 3 months prior to informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

1218.37.49003 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1218.37.49002 Boehringer Ingelheim Investigational Site

Mainz, Germany

Location

1218.37.49001 Boehringer Ingelheim Investigational Site

Neuss, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

LinagliptinSitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinazolinesTriazolesAzolesHeterocyclic Compounds, 1-RingPyrazines

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 15, 2008

First Posted

July 16, 2008

Study Start

July 1, 2008

Primary Completion

November 1, 2008

Last Updated

June 27, 2014

Results First Posted

June 15, 2011

Record last verified: 2014-01

Locations

DE(3)