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Linagliptin in Combination With Metformin in Treatment Naive Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control

NCT ID: NCT01438814

Last Updated: 2014-11-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

689 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-03-31

Brief Summary

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The aim of this study is to investigate the impact of the combination therapy of linagliptin and metformin at submaximal doses in reduction of Glycosylated haemoglobin (HbA1c) and metformin pre-specified gastro-intestinal (GI) side effects in treatment naive patients of with type 2 diabetes mellitus.

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 + metformin

patients to receive linagliptin +metformin QD

Group Type EXPERIMENTAL

metformin

Intervention Type DRUG

metformin tablets 500 mg

linagliptin

Intervention Type DRUG

linagliptin tablets 5mg

metformin

patients to receive metformin BID

Group Type ACTIVE_COMPARATOR

metformin placebo

Intervention Type DRUG

metformin placebo tablets 500mg

linagliptin placebo

Intervention Type DRUG

linagliptin placebo tablets 5mg

metformin

Intervention Type DRUG

metformin tablets 500mg

Interventions

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metformin placebo

metformin placebo tablets 500mg

Intervention Type DRUG

linagliptin placebo

linagliptin placebo tablets 5mg

Intervention Type DRUG

metformin

metformin tablets 500mg

Intervention Type DRUG

metformin

metformin tablets 500 mg

Intervention Type DRUG

linagliptin

linagliptin tablets 5mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of Type 2 diabetes mellitus (T2DM) prior to informed consent;
2. Male and female patients on diet and exercise regimen who are drug naive, defined as absence of any oral antidiabetic therapy or insulin for 12 weeks prior to randomization
3. Glycosylated haemoglobin A1c (HbA1c) \>/= 7.0% (53 mmol/mol) to \</= 10.0% (86 mmol/mol) at visit 1 (screening);
4. Age\>/=18 and \</=80 years at visit 1(screening);
5. Body Mass Index (BMI)\</= 45kg/m2 at visit 1 (screening);
6. Signed and dated written informed consent by date of visit 1 in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria

1. Uncontrolled hyperglycaemia with a glucose level \>240 mg/dl (13.3mmol/L) after an overnight fast during screening/placebo run-in and confirmed by a second measurement (Not on the same day);
2. Treatment with any oral antidiabetic drug or insulin within 12 weeks prior to randomization
3. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris),stroke or Transient ischemia attack (TIA) within 3 months prior to informed consent;
4. Indication of liver disease/Impaired hepatic function, defined by serum levels of either Aspartate aminotransferase (ALT or SGPT), alanine aminotransferase (AST or SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at visit 1 and/or run-in phase,
5. Impaired renal function, defined as eGFR\< 60ml/min (moderate or severe renal impairment, modification of diet in renal disease (MDRD) formula) as determined during screening or at run-in phase
6. Bariatric surgery within the past two years and other gastrointestinal surgeries that induced chronic malabsorption
7. Medical history of Cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
8. Blood dyscrasia or any other disorders causing haemolysis or unstable Red Blood Cell (eg. malaria, babesiosis, haemolytic anemia)
9. Known history of pancreatitis and chronic pancreatitis
10. Contraindications to metformin according to the local label
11. Treatment with anti-obesity drugs 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
12. 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 T2DM
13. Pre-menopausal women (last menstruation less than 1 year prior to informed consent) who:

1. are nursing or pregnant or
2. 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 study and do not agree to submit to periodic pregnancy testing during participation in the trial or who do not agree to continue contraception for at least 30 days after the last dose of study drug. Acceptable methods of birth control include tubal ligation, transdermal patch, intra-uterine devices/systems(IUDs/IUSs), oral, implantable, or injectable contraceptives, complete sexual abstinence (if acceptable by local authorities), double barrier method and vasectomized partner.
14. Alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
15. Participation in another trial with application of any investigational drug within 30 days prior to informed consent
16. Any other clinical condition that would jeopardize patients safety while participating in this trial
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 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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1218.60.90001 Boehringer Ingelheim Investigational Site

Dhaka, , Bangladesh

Site Status

1218.60.90002 Boehringer Ingelheim Investigational Site

Dhaka, , Bangladesh

Site Status

1218.60.90003 Boehringer Ingelheim Investigational Site

Dhaka, , Bangladesh

Site Status

1218.60.32001 Boehringer Ingelheim Investigational Site

Genk, , Belgium

Site Status

1218.60.32005 Boehringer Ingelheim Investigational Site

Ham, , Belgium

Site Status

1218.60.32002 Boehringer Ingelheim Investigational Site

Hasselt, , Belgium

Site Status

1218.60.32004 Boehringer Ingelheim Investigational Site

Natoye, , Belgium

Site Status

1218.60.32003 Boehringer Ingelheim Investigational Site

Tremelo, , Belgium

Site Status

1218.60.20009 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Site Status

1218.60.20003 Boehringer Ingelheim Investigational Site

Burnaby, British Columbia, Canada

Site Status

1218.60.20014 Boehringer Ingelheim Investigational Site

Coquitlam, British Columbia, Canada

Site Status

1218.60.20010 Boehringer Ingelheim Investigational Site

Surrey, British Columbia, Canada

Site Status

1218.60.20004 Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

Site Status

1218.60.20012 Boehringer Ingelheim Investigational Site

Corunna, Ontario, Canada

Site Status

1218.60.20015 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Site Status

1218.60.20006 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

Site Status

1218.60.20013 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

Site Status

1218.60.20002 Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

Site Status

1218.60.20011 Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

Site Status

1218.60.20005 Boehringer Ingelheim Investigational Site

Strathroy, Ontario, Canada

Site Status

1218.60.20007 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1218.60.20016 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1218.60.20001 Boehringer Ingelheim Investigational Site

Saint Romuald, Quebec, Canada

Site Status

1218.60.86001 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1218.60.86003 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1218.60.86011 Boehringer Ingelheim Investigational Site

Changsha, , China

Site Status

1218.60.86012 Boehringer Ingelheim Investigational Site

Chengdu, , China

Site Status

1218.60.86010 Boehringer Ingelheim Investigational Site

Chongqing, , China

Site Status

1218.60.86013 Boehringer Ingelheim Investigational Site

Hubei, , China

Site Status

1218.60.86014 Boehringer Ingelheim Investigational Site

Hubei, , China

Site Status

1218.60.86006 Boehringer Ingelheim Investigational Site

Nanjing, , China

Site Status

1218.60.86007 Boehringer Ingelheim Investigational Site

Nanjing, , China

Site Status

1218.60.86005 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1218.60.86009 Boehringer Ingelheim Investigational Site

Shenyang, , China

Site Status

1218.60.86008 Boehringer Ingelheim Investigational Site

Wuxi, , China

Site Status

1218.60.49007 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1218.60.49008 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1218.60.49005 Boehringer Ingelheim Investigational Site

Dresden, , Germany

Site Status

1218.60.49004 Boehringer Ingelheim Investigational Site

Erfurt, , Germany

Site Status

1218.60.49006 Boehringer Ingelheim Investigational Site

Frankfurt, , Germany

Site Status

1218.60.49003 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1218.60.49002 Boehringer Ingelheim Investigational Site

Neuwied, , Germany

Site Status

1218.60.49001 Boehringer Ingelheim Investigational Site

Unterschneidheim, , Germany

Site Status

1218.60.50001 Boehringer Ingelheim Investigational Site

Guatemala City, , Guatemala

Site Status

1218.60.50002 Boehringer Ingelheim Investigational Site

Guatemala City, , Guatemala

Site Status

1218.60.50003 Boehringer Ingelheim Investigational Site

Guatemala City, , Guatemala

Site Status

1218.60.85001 Boehringer Ingelheim Investigational Site

Hong Kong, , Hong Kong

Site Status

1218.60.85002 Boehringer Ingelheim Investigational Site

Hong Kong, , Hong Kong

Site Status

1218.60.91004 Boehringer Ingelheim Investigational Site

Aurangabad, , India

Site Status

1218.60.91010 Boehringer Ingelheim Investigational Site

Bangalore, , India

Site Status

1218.60.91005 Boehringer Ingelheim Investigational Site

Coimbatore, , India

Site Status

1218.60.91008 Boehringer Ingelheim Investigational Site

Kolkata, , India

Site Status

1218.60.91001 Boehringer Ingelheim Investigational Site

Nagpur, , India

Site Status

1218.60.91007 Boehringer Ingelheim Investigational Site

Nagpur, , India

Site Status

1218.60.91003 Boehringer Ingelheim Investigational Site

Pune, , India

Site Status

1218.60.91006 Boehringer Ingelheim Investigational Site

Pune, , India

Site Status

1218.60.96001 Boehringer Ingelheim Investigational Site

Beirut, , Lebanon

Site Status

1218.60.96002 Boehringer Ingelheim Investigational Site

Beirut, , Lebanon

Site Status

1218.60.96004 Boehringer Ingelheim Investigational Site

Byblos, , Lebanon

Site Status

1218.60.96003 Boehringer Ingelheim Investigational Site

Hazmiyeh, , Lebanon

Site Status

1218.60.96005 Boehringer Ingelheim Investigational Site

Saida, , Lebanon

Site Status

1218.60.52005 Boehringer Ingelheim Investigational Site

Aguascalientes, , Mexico

Site Status

1218.60.52003 Boehringer Ingelheim Investigational Site

Cuernavaca, , Mexico

Site Status

1218.60.52001 Boehringer Ingelheim Investigational Site

Durango, , Mexico

Site Status

1218.60.52002 Boehringer Ingelheim Investigational Site

Durango, , Mexico

Site Status

1218.60.52004 Boehringer Ingelheim Investigational Site

Monterrey, , Mexico

Site Status

1218.60.51001 Boehringer Ingelheim Investigational Site

Lima, , Peru

Site Status

1218.60.51002 Boehringer Ingelheim Investigational Site

Lima, , Peru

Site Status

1218.60.51004 Boehringer Ingelheim Investigational Site

Piura, , Peru

Site Status

1218.60.63001 Boehringer Ingelheim Investigational Site

Cebu City, Philippines, , Philippines

Site Status

1218.60.63004 Boehringer Ingelheim Investigational Site

Iloilo City, Philippines, , Philippines

Site Status

1218.60.63003 Boehringer Ingelheim Investigational Site

Manila, , Philippines

Site Status

1218.60.63002 Boehringer Ingelheim Investigational Site

Marikina City, Philippines, , Philippines

Site Status

1218.60.63005 Boehringer Ingelheim Investigational Site

Quezon City, , Philippines

Site Status

1218.60.34001 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1218.60.34002 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1218.60.34003 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1218.60.34004 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1218.60.34006 Boehringer Ingelheim Investigational Site

Borges Del Camp- Tarragona, , Spain

Site Status

1218.60.34005 Boehringer Ingelheim Investigational Site

Centelles, , Spain

Site Status

1218.60.34009 Boehringer Ingelheim Investigational Site

Granada, , Spain

Site Status

1218.60.34008 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat, , Spain

Site Status

1218.60.34007 Boehringer Ingelheim Investigational Site

Mataró, , Spain

Site Status

1218.60.34010 Boehringer Ingelheim Investigational Site

Valencia, , Spain

Site Status

1218.60.88006 Boehringer Ingelheim Investigational Site

Chiayi County, , Taiwan

Site Status

1218.60.88003 Boehringer Ingelheim Investigational Site

Kaohsiung City, , Taiwan

Site Status

1218.60.88001 Boehringer Ingelheim Investigational Site

Taichung, , Taiwan

Site Status

1218.60.88007 Boehringer Ingelheim Investigational Site

Taichung, , Taiwan

Site Status

1218.60.88002 Boehringer Ingelheim Investigational Site

Tainan City, , Taiwan

Site Status

1218.60.88004 Boehringer Ingelheim Investigational Site

Taipei County, , Taiwan

Site Status

Countries

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Bangladesh Belgium Canada China Germany Guatemala Hong Kong India Lebanon Mexico Peru Philippines Spain Taiwan

References

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Ji L, Zinman B, Patel S, Ji J, Bailes Z, Thiemann S, Seck T. Efficacy and safety of linagliptin co-administered with low-dose metformin once daily versus high-dose metformin twice daily in treatment-naive patients with type 2 diabetes: a double-blind randomized trial. Adv Ther. 2015 Mar;32(3):201-15. doi: 10.1007/s12325-015-0195-3. Epub 2015 Mar 25.

Reference Type DERIVED
PMID: 25805187 (View on PubMed)

Other Identifiers

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2011-002276-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1218.60

Identifier Type: -

Identifier Source: org_study_id