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Linagliptin and Metformin Versus Linagliptin in Newly Diagnosed, Untreated Type 2 Diabetes

NCT ID: NCT01512979

Last Updated: 2014-05-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-04-30

Brief Summary

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The purpose of this trial is to determine whether a initial combination of linagliptin and metformin compared to linagliptin alone for 24 weeks is effective in newly diagnosed, treatment-naïve patients with Type 2 Diabetes.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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linagliptin

patients receive linagliptin tablet once daily

Group Type EXPERIMENTAL

linagliptin

Intervention Type DRUG

5 mg daily

metformin placebo

Intervention Type DRUG

4 tablets daily

linagliptin plus metformin

patients receive linagliptin tablet once daily and metformin tablets twice daily

Group Type EXPERIMENTAL

metformin

Intervention Type DRUG

1000 mg to 2000 mg per day

linagliptin

Intervention Type DRUG

5 mg daily

metformin placebo

Intervention Type DRUG

0 to 2 tablets daily

Interventions

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metformin

1000 mg to 2000 mg per day

Intervention Type DRUG

linagliptin

5 mg daily

Intervention Type DRUG

metformin placebo

0 to 2 tablets daily

Intervention Type DRUG

metformin placebo

4 tablets daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients must sign and date an Informed Consent consistent with International Conference on Harmonisation / Good Clinical Practice guidelines and local regulations prior to any evaluation and participation in the trial.
2. Male and female patients, 18 years of age or older at Visit 1 (Screen), with newly diagnosed (less than 12 months prior to Screen) Type 2 Diabetes Mellitus.
3. Patients who are treatment-naïve, defined as absence of any oral antidiabetic therapy, injectable glucagon-like peptide-1 agonist/analogue, or insulin, and uncontrolled for the 12 weeks prior to randomisation.
4. Patients must have an glycated (or glycosylated) haemoglobin (HbA1c) between 8.5% \[69 millimoles per mole (mmol/mol)\] and 12.0% (108 mmol/mol) at Visit 1 (Screen).
5. Patients must have a Body Mass Index (BMI) of 45 kg/m2 or less at Visit 1 (Screen).
6. In the investigators opinion, patients must be reliable, honest, compliant, and agree to cooperate with all planned future trial evaluations as explained in detail during the informed consent process and to be able to perform them.

Exclusion Criteria

Patients with, who are, who have, or who have had:

1. Acute coronary syndrome (non-ST Elevation Myocardial Infarction (STEMI), STEMI, and unstable angina pectoris), stroke or transient ischemic attack within 3 months prior to informed consent.
2. Indication of liver disease determined during Screen and/or Run-In Period, defined by a serum level above 3 times the upper limit of normal (ULN) in any of the following: alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase. Gilbert-Meulengracht syndrome (also known as conjugated hyperbilirubinemia, constitutional hepatic dysfunction, or familial nonhemolytic jaundice) will be permitted.
3. Impaired renal function, defined as calculated creatinine clearance of less than 60 milliliters per minute (\< 60 mL/min), by the Cockcroft-Gault Equation, as determined during Screen and/or Run-In Period.
4. Bariatric, gastric bypass, and other gastrointestinal surgeries (including all types of gastric banding and/or LapBand) within the past two years.
5. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.
6. Medical history of pancreatitis.
7. Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells (e.g., malaria, babesiosis, haemolytic anaemia).
8. Any contraindication to metformin and/or linagliptin therapies, according to local labels.
9. Treatment with anti-obesity drugs, including over-the-counter drugs such as Alli (orlistat), 3 months prior to informed consent or any other treatment at the time of screening (i.e., surgery, aggressive diet regimen, etc.) leading to unstable body weight.
10. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except Type 2 Diabetes Mellitus.
11. Pre-menopausal women (last menstruation of 1 year or less prior to informed consent) who are nursing or pregnant, are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the trial and do not agree to submit to periodic pregnancy testing during participation in the trial.

Note: Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable, intra-vaginal, or injectable contraceptives, Essure micro-inserts placed more than six months prior to Screen Visit, complete sexual abstinence (if acceptable by local authorities), double barrier method (e.g., diaphragm or condom and spermicide), and vasectomised partner.
12. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance to trial procedures or study medication intake in the opinion of the investigator.
13. Participation in another trial with an investigational drug within 2 months prior to informed consent.
14. Any other clinical condition that would jeopardize patient safety while participating in this clinical trial in the opinion of the Investigator.
15. Inability to commit to regular overnight fasting of at least 10 hours duration and attendance to study site visits between 07:00 and 11:00 ante meridiem (a.m.).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1218.83.11002 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Site Status

1218.83.11036 Boehringer Ingelheim Investigational Site

Little Rock, Arkansas, United States

Site Status

1218.83.11011 Boehringer Ingelheim Investigational Site

Chino, California, United States

Site Status

1218.83.11001 Boehringer Ingelheim Investigational Site

Huntington Beach, California, United States

Site Status

1218.83.11019 Boehringer Ingelheim Investigational Site

Huntington Park, California, United States

Site Status

1218.83.11015 Boehringer Ingelheim Investigational Site

Lomita, California, United States

Site Status

1218.83.11023 Boehringer Ingelheim Investigational Site

Norwalk, California, United States

Site Status

1218.83.11014 Boehringer Ingelheim Investigational Site

Roseville, California, United States

Site Status

1218.83.11031 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Site Status

1218.83.11022 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Site Status

1218.83.11025 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Site Status

1218.83.11033 Boehringer Ingelheim Investigational Site

Sanford, Florida, United States

Site Status

1218.83.11029 Boehringer Ingelheim Investigational Site

Oakwood, Georgia, United States

Site Status

1218.83.11026 Boehringer Ingelheim Investigational Site

Owensboro, Kentucky, United States

Site Status

1218.83.11008 Boehringer Ingelheim Investigational Site

Elkton, Maryland, United States

Site Status

1218.83.11027 Boehringer Ingelheim Investigational Site

Freemont, Nebraska, United States

Site Status

1218.83.11005 Boehringer Ingelheim Investigational Site

Edison, New Jersey, United States

Site Status

1218.83.11013 Boehringer Ingelheim Investigational Site

Jacksonville, North Carolina, United States

Site Status

1218.83.11028 Boehringer Ingelheim Investigational Site

Salisbury, North Carolina, United States

Site Status

1218.83.11009 Boehringer Ingelheim Investigational Site

Shelby, North Carolina, United States

Site Status

1218.83.11003 Boehringer Ingelheim Investigational Site

Franklin, Ohio, United States

Site Status

1218.83.11024 Boehringer Ingelheim Investigational Site

Gallipolis, Ohio, United States

Site Status

1218.83.11018 Boehringer Ingelheim Investigational Site

Columbia, South Carolina, United States

Site Status

1218.83.11004 Boehringer Ingelheim Investigational Site

Bristol, Tennessee, United States

Site Status

1218.83.11017 Boehringer Ingelheim Investigational Site

Chattanooga, Tennessee, United States

Site Status

1218.83.11032 Boehringer Ingelheim Investigational Site

Grand Prairie, Texas, United States

Site Status

1218.83.11030 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

1218.83.11034 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

1218.83.11021 Boehringer Ingelheim Investigational Site

Tomball, Texas, United States

Site Status

1218.83.12011 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Site Status

1218.83.12007 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Site Status

1218.83.12001 Boehringer Ingelheim Investigational Site

Red Deer, Alberta, Canada

Site Status

1218.83.12002 Boehringer Ingelheim Investigational Site

Paradise, Newfoundland and Labrador, Canada

Site Status

1218.83.12009 Boehringer Ingelheim Investigational Site

St. John's, Newfoundland and Labrador, Canada

Site Status

1218.83.12010 Boehringer Ingelheim Investigational Site

Greater Sudbury, Ontario, Canada

Site Status

1218.83.12005 Boehringer Ingelheim Investigational Site

Kitchener, Ontario, Canada

Site Status

1218.83.12006 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

Site Status

1218.83.12003 Boehringer Ingelheim Investigational Site

Smiths Falls, Ontario, Canada

Site Status

1218.83.12012 Boehringer Ingelheim Investigational Site

Winnipeg, Ontario, Canada

Site Status

1218.83.91003 Boehringer Ingelheim Investigational Site

Bangalore, , India

Site Status

1218.83.91005 Boehringer Ingelheim Investigational Site

Chennai, , India

Site Status

1218.83.91001 Boehringer Ingelheim Investigational Site

Mumbai, , India

Site Status

1218.83.97004 Boehringer Ingelheim Investigational Site

Haifa, , Israel

Site Status

1218.83.97005 Boehringer Ingelheim Investigational Site

Haifa, , Israel

Site Status

1218.83.97007 Boehringer Ingelheim Investigational Site

Holon, , Israel

Site Status

1218.83.60001 Boehringer Ingelheim Investigational Site

Kelantan, , Malaysia

Site Status

1218.83.60002 Boehringer Ingelheim Investigational Site

Perak, , Malaysia

Site Status

1218.83.60003 Boehringer Ingelheim Investigational Site

Selangor, Malaysia, , Malaysia

Site Status

1218.83.52004 Boehringer Ingelheim Investigational Site

Cuautla, , Mexico

Site Status

1218.83.52001 Boehringer Ingelheim Investigational Site

Guadalajara, , Mexico

Site Status

1218.83.52002 Boehringer Ingelheim Investigational Site

Guadalajara, , Mexico

Site Status

1218.83.52005 Boehringer Ingelheim Investigational Site

Mérida, , Mexico

Site Status

1218.83.52003 Boehringer Ingelheim Investigational Site

Tampico, , Mexico

Site Status

1218.83.63001 Boehringer Ingelheim Investigational Site

Cebu, , Philippines

Site Status

1218.83.63007 Boehringer Ingelheim Investigational Site

Cebu City, , Philippines

Site Status

1218.83.63003 Boehringer Ingelheim Investigational Site

Iloilo City, , Philippines

Site Status

1218.83.63008 Boehringer Ingelheim Investigational Site

Iloilo City, , Philippines

Site Status

1218.83.63002 Boehringer Ingelheim Investigational Site

Marikina City, , Philippines

Site Status

1218.83.63006 Boehringer Ingelheim Investigational Site

Marikina City, , Philippines

Site Status

1218.83.63004 Boehringer Ingelheim Investigational Site

Quezon, , Philippines

Site Status

1218.83.11037 Boehringer Ingelheim Investigational Site

San Juan, , Puerto Rico

Site Status

1218.83.07001 Boehringer Ingelheim Investigational Site

Kazan', , Russia

Site Status

1218.83.07002 Boehringer Ingelheim Investigational Site

Petrozavodsk, , Russia

Site Status

1218.83.07003 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1218.83.07007 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1218.83.07004 Boehringer Ingelheim Investigational Site

Samara, , Russia

Site Status

1218.83.07006 Boehringer Ingelheim Investigational Site

Smolensk, , Russia

Site Status

1218.83.07005 Boehringer Ingelheim Investigational Site

Yaroslavl, , Russia

Site Status

1218.83.94004 Boehringer Ingelheim Investigational Site

Dehiwala, , Sri Lanka

Site Status

1218.83.94002 Boehringer Ingelheim Investigational Site

Galle, Sri Lanka, , Sri Lanka

Site Status

1218.83.94003 Boehringer Ingelheim Investigational Site

Kandy, , Sri Lanka

Site Status

1218.83.94001 Boehringer Ingelheim Investigational Site

Ragama, , Sri Lanka

Site Status

1218.83.66002 Boehringer Ingelheim Investigational Site

Bangkok, , Thailand

Site Status

1218.83.66003 Boehringer Ingelheim Investigational Site

Bangkok, , Thailand

Site Status

1218.83.66001 Boehringer Ingelheim Investigational Site

Muang, Khonkaen, , Thailand

Site Status

1218.83.38007 Boehringer Ingelheim Investigational Site

Dnipro, , Ukraine

Site Status

1218.83.38001 Boehringer Ingelheim Investigational Site

Ivano-Frankivsk, , Ukraine

Site Status

1218.83.38006 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

1218.83.38004 Boehringer Ingelheim Investigational Site

Odesa, , Ukraine

Site Status

1218.83.38008 Boehringer Ingelheim Investigational Site

Vinnitsa, , Ukraine

Site Status

1218.83.38003 Boehringer Ingelheim Investigational Site

Vinnytsia, , Ukraine

Site Status

1218.83.38005 Boehringer Ingelheim Investigational Site

Vinnytsia, , Ukraine

Site Status

Countries

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United States Canada India Israel Malaysia Mexico Philippines Puerto Rico Russia Sri Lanka Thailand Ukraine

References

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Ross SA, Caballero AE, Del Prato S, Gallwitz B, Lewis-D'Agostino D, Bailes Z, Thiemann S, Patel S, Woerle HJ, von Eynatten M. Linagliptin plus metformin in patients with newly diagnosed type 2 diabetes and marked hyperglycemia. Postgrad Med. 2016 Nov;128(8):747-754. doi: 10.1080/00325481.2016.1238280. Epub 2016 Sep 29.

Reference Type DERIVED
PMID: 27684308 (View on PubMed)

Other Identifiers

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2011-004158-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1218.83

Identifier Type: -

Identifier Source: org_study_id

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