NCT01204294

Brief Summary

The objective of the current study is to investigate the safety and efficacy of linagliptin (5mg / once daily) given for 52 weeks as add-on therapy to patients with type 2 diabetes mellitus and insufficient glycaemic control despite diet, exercise, and treatment with one approved antidiabetic drug.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
574

participants targeted

Target at P50-P75 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

43 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

September 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 23, 2013

Completed
Last Updated

March 28, 2014

Status Verified

February 1, 2014

Enrollment Period

1.3 years

First QC Date

September 16, 2010

Results QC Date

December 18, 2012

Last Update Submit

February 27, 2014

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Incidence of Adverse Events (AEs)

    The number of patient with any AEs, patients with severe AE, patients with AEs leading to discontinuation of trial drug, and patients with Hypoglycaemic events

    The first drug administration through 7 days after the last drug administration, up to 382 days

Secondary Outcomes (1)

  • Glycosylated Haemoglobin A1c (HbA1c)

    Baseline and 52 weeks

Study Arms (7)

Bigu+Lina

EXPERIMENTAL

biguanide plus linagliptin

Drug: Linagliptin

Glin+Lina

EXPERIMENTAL

glinide plus linagliptin

Drug: Linagliptin

Glit+Lina

EXPERIMENTAL

glitazone plus linagliptin

Drug: Linagliptin

SU+Lina

EXPERIMENTAL

sulfonylurea plus linagliptin

Drug: Linagliptin

A-GI+Lina

EXPERIMENTAL

alpha-glucosidase inhibitor plus linagliptin

Drug: Linagliptin

SU+Met

ACTIVE COMPARATOR

sulfonylurea plus metformin

Drug: Metformin

A-GI+Met

ACTIVE COMPARATOR

alpha-glucosidase inhibitor plus metformin

Drug: Metformin

Interventions

LinagliptinDRUG

Linagliptin once daily

Glin+Lina
MetforminDRUG

Metformin twice or three time per day

A-GI+Met

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of type 2 diabetes mellitus
  • Male and female patients on diet and exercise regimen who are treated with one antidiabetic drug

You may not qualify if:

  • Myocardial infarction, stroke, transient ischemic attack, or pulmonary embolism
  • Impaired hepatic function
  • Glitazone, glinide, and sulfonylurea group: renal failure or renal impairment defined as estimated glomerular filtration rate \<30 ml/min (severe renal impairment) at Visit 1, Biguanide group: renal failure or renal impairment defined as estimated glomerular filtration rate \<60 ml/min (moderate renal impairment) at Visit 1
  • Treatment with anti-obesity drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (43)

1218.78.008 Boehringer Ingelheim Investigational Site

Akishima, Tokyo, Japan

Location

1218.78.030 Boehringer Ingelheim Investigational Site

Amagasaki, Hyogo, Japan

Location

1218.78.017 Boehringer Ingelheim Investigational Site

Annaka, Gunma, Japan

Location

1218.78.006 Boehringer Ingelheim Investigational Site

Aomori, Aomori, Japan

Location

1218.78.007 Boehringer Ingelheim Investigational Site

Aomori, Aomori, Japan

Location

1218.78.009 Boehringer Ingelheim Investigational Site

Chuo-ku, Tokyo, Japan

Location

1218.78.013 Boehringer Ingelheim Investigational Site

Chuo-ku, Tokyo, Japan

Location

1218.78.032 Boehringer Ingelheim Investigational Site

Fukuoka, Fukuoka, Japan

Location

1218.78.040 Boehringer Ingelheim Investigational Site

Fukuoka, Fukuoka, Japan

Location

1218.78.037 Boehringer Ingelheim Investigational Site

Higashi Osaka, Osaka, Japan

Location

1218.78.043 Boehringer Ingelheim Investigational Site

Hitachinaka, Ibaraki, Japan

Location

1218.78.019 Boehringer Ingelheim Investigational Site

Isesaki, Gunma, Japan

Location

1218.78.036 Boehringer Ingelheim Investigational Site

Kashiwara, Osaka, Japan

Location

1218.78.026 Boehringer Ingelheim Investigational Site

Kasugai, Aichi, Japan

Location

1218.78.038 Boehringer Ingelheim Investigational Site

Kawachinagano, Osaka, Japan

Location

1218.78.021 Boehringer Ingelheim Investigational Site

Kitaazumi-gun, Nagano, Japan

Location

1218.78.022 Boehringer Ingelheim Investigational Site

Matsumoto, Nagano, Japan

Location

1218.78.033 Boehringer Ingelheim Investigational Site

Matsumoto, Nagano, Japan

Location

1218.78.012 Boehringer Ingelheim Investigational Site

Meguro-ku, Tokyo, Japan

Location

1218.78.041 Boehringer Ingelheim Investigational Site

Meguro-ku, Tokyo, Japan

Location

1218.78.034 Boehringer Ingelheim Investigational Site

Morioka, Iwate, Japan

Location

1218.78.035 Boehringer Ingelheim Investigational Site

Morioka, Iwate, Japan

Location

1218.78.018 Boehringer Ingelheim Investigational Site

Moriya, Ibaraki, Japan

Location

1218.78.024 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, Japan

Location

1218.78.025 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, Japan

Location

1218.78.027 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, Japan

Location

1218.78.028 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, Japan

Location

1218.78.031 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, Japan

Location

1218.78.039 Boehringer Ingelheim Investigational Site

Oita, Oita, Japan

Location

1218.78.004 Boehringer Ingelheim Investigational Site

Okinawa, Okinawa, Japan

Location

1218.78.016 Boehringer Ingelheim Investigational Site

Sagae, Yamagata, Japan

Location

1218.78.001 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1218.78.020 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1218.78.042 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1218.78.005 Boehringer Ingelheim Investigational Site

Shimajiri-gun, Okinawa, Japan

Location

1218.78.014 Boehringer Ingelheim Investigational Site

Shinjuku-ku, Tokyo, Japan

Location

1218.78.002 Boehringer Ingelheim Investigational Site

Shinjyuku-ku. Tokyo, Japan

Location

1218.78.011 Boehringer Ingelheim Investigational Site

Shizuoka, Shizuoka, Japan

Location

1218.78.003 Boehringer Ingelheim Investigational Site

Suita, Osaka, Japan

Location

1218.78.023 Boehringer Ingelheim Investigational Site

Tokorozawa, Saitama, Japan

Location

1218.78.029 Boehringer Ingelheim Investigational Site

Tokorozawa, Saitama, Japan

Location

1218.78.010 Boehringer Ingelheim Investigational Site

Tsuchiura, Ibaraki, Japan

Location

1218.78.015 Boehringer Ingelheim Investigational Site

Yamagata, Yamagata, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

LinagliptinMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinazolinesBiguanidesGuanidinesAmidinesOrganic Chemicals

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
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2010

First Posted

September 17, 2010

Study Start

September 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

March 28, 2014

Results First Posted

January 23, 2013

Record last verified: 2014-02

Locations

JP(43)