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Efficacy and Safety Study of Linagliptin (5 mg Administered Orally Once Daily) Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy

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ClinicalTrials.gov Identifier: NCT01215097
Recruitment Status : Completed
First Posted : October 6, 2010
Results First Posted : June 3, 2013
Last Update Posted : August 25, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
In this randomised, double-blind, parallel group trial, the safety and efficacy of 5 mg of Linagliptin administered orally once daily will be compared with a placebo after 24 weeks of treatment as add-on therapy to metformin in patients with type 2 diabetes and insufficient glycaemic control.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Linagliptin Drug: placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 Over 24 Weeks in T2D Patients With Insufficient Glycaemic Control Despite Metformin Therapy
Study Start Date : October 2010
Primary Completion Date : April 2012
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Linagliptin
once a day
Drug: Linagliptin
once a day
Placebo Comparator: placebo
once a day
Drug: placebo
once a day


Outcome Measures

Primary Outcome Measures :
  1. HbA1c Change From Baseline at Week 24 [ Time Frame: Baseline and at week 24 ]
    Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.


Secondary Outcome Measures :
  1. HbA1c Change From Baseline at Week 6 [ Time Frame: Baseline and at week 6 ]
    Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

  2. HbA1c Change From Baseline at Week 12 [ Time Frame: Baseline and at week 12 ]
    Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

  3. HbA1c Change From Baseline at Week 18 [ Time Frame: Baseline and at week 18 ]
    Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

  4. HbA1c Change From Baseline at Week 24(Chinese Only) [ Time Frame: Baseline and at 24 weeks ]
    Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

  5. FPG Change From Baseline at Week 24 [ Time Frame: Baseline and at week 24 ]
    Means are treatment adjusted for baseline fasting plasma glucose (FPG) and previous anti-diabetic medication.

  6. FPG Change From Baseline at Week 6 [ Time Frame: Baseline and at week 6 ]
    Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.

  7. FPG Change From Baseline at Week 12 [ Time Frame: Baseline and at week 12 ]
    Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.

  8. FPG Change From Baseline at Week 18 [ Time Frame: Baseline and at week 18 ]
    Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.

  9. Number of Patients With HbA1c < 7.0% [ Time Frame: baseline and at week 24 ]
    Number of patients with HbA1c < 7.0% at week 24

  10. Number of Patients With HbA1c < 7.0% at Week 24 With Baseline HbA1c >= 7.0%. [ Time Frame: baseline and at week 24 ]
    Number of patients with HbA1c < 7.0% at week 24 with baseline HbA1c >= 7.0%.

  11. Number of Patients With HbA1c < 6.5% [ Time Frame: baseline and at week 24 ]
    Number of patients with HbA1c < 6.5% at week 24

  12. Number of Patients With HbA1c < 6.5% at Week 24 With Baseline HbA1c >= 6.5%. [ Time Frame: baseline and at week 24 ]
    Number of patients with HbA1c < 6.5% at week 24 with baseline HbA1c >= 6.5%.

  13. Number With HbA1c at Least Lowering 0.5% [ Time Frame: baseline and at week 24 ]
    Number with HbA1c at least 0.5% lowering from baseline at week 24


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone, or with metformin and not more than one other oral antidiabetic drug (antidiabetic therapy has to be unchanged for 6 weeks prior to informed consent and patients should receive standard diet and exercise counseling) A dose of >/=1500 mg/day metformin is required for inclusion into the trial. The dosage needs to be stable for at least 8 weeks before randomisation. Patients with a total daily dose of less than 1500 mg metformin will only be included; if the investigator has documented them to be on their maximum tolerated dose (also in this case the 8 week time interval will apply for a stable dose).
  2. Diagnosis of type 2 diabetes prior to informed consent
  3. Glycosylated haemoglobin A1 (HbA1c) at Visit 1a (Screening):

    For patients undergoing wash out of previous medication: HbA1c =7.0 to =9.5% For patients not undergoing wash-out of previous medication: HbA1c =7.0 to =10.0%

  4. Glycosylated haemoglobin A1 (HbA1c) =7.0 to =10.0% at Visit 2 (Start of Run-in)
  5. Age = 18 and < 80 years at Visit 1a (Screening)
  6. BMI (Body Mass Index) = 45 kg/m2 at Visit 1a (Screening)
  7. Signed and dated written informed consent by date of Visit 1a in accordance with GCP and local legislation

Exclusion criteria:

  1. Myocardial infarction, stroke or TIA within 6 months prior to informed consent
  2. Impaired hepatic function, defined by serum levels of either Alanine transaminase,Aspartate transaminase, or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at Visit 1a
  3. Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during wash-out / placebo run-in and confirmed by a second measurement (not on the same day).
  4. Known hypersensitivity or allergy to the investigational product or its excipients or metformin or placebo
  5. Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent
  6. Treatment with an injectable Glucagon-like peptide- 1 (GLP-1) analogue (e.g. exenatide) , Dipeptidyl-Peptidase 4 (DPP-IV) inhibitor within 3 months prior to informed consent
  7. Treatment with insulin within 3 months prior to informed consent
  8. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent.
  9. Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse
  10. Participation in another trial with an investigational drug within 2 months prior to informed consent
  11. Pre-menopausal women (last menstruation =1 year prior to informed consent) who:

    • are nursing or pregnant,
    • or 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. Acceptable methods of birth control include transdermal patch, intra-uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. No exception will be made.
  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.
  13. Renal failure or renal impairment (serum creatinine =1.5 mg/dl as determined at Visit 1a)
  14. Dehydration by clinical judgement of the investigator
  15. Unstable or acute congestive heart failure
  16. Acute or chronic metabolic acidosis (present in patient history)
  17. Hereditary galactose intolerance
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01215097


Locations
China
1218.65.86007 Boehringer Ingelheim Investigational Site
Beijing, China
1218.65.86011 Boehringer Ingelheim Investigational Site
Chongqing, China
1218.65.86008 Boehringer Ingelheim Investigational Site
Dalian, China
1218.65.86010 Boehringer Ingelheim Investigational Site
Fuzhou, China
1218.65.86014 Boehringer Ingelheim Investigational Site
Hangzhou, China
1218.65.86005 Boehringer Ingelheim Investigational Site
Hefei, China
1218.65.86006 Boehringer Ingelheim Investigational Site
Hefei, China
1218.65.86012 Boehringer Ingelheim Investigational Site
Nanjing, China
1218.65.86001 Boehringer Ingelheim Investigational Site
Shanghai, China
1218.65.86002 Boehringer Ingelheim Investigational Site
Shanghai, China
1218.65.86003 Boehringer Ingelheim Investigational Site
Shanghai, China
1218.65.86004 Boehringer Ingelheim Investigational Site
Suzhou, China
1218.65.86015 Boehringer Ingelheim Investigational Site
Wenzhou, China
1218.65.86009 Boehringer Ingelheim Investigational Site
Wuhan, China
1218.65.86013 Boehringer Ingelheim Investigational Site
Yangzhou, China
Malaysia
1218.65.60002 Boehringer Ingelheim Investigational Site
Johor Bahru,, Malaysia
1218.65.60001 Boehringer Ingelheim Investigational Site
Kelantan, Malaysia
Philippines
1218.65.63001 Boehringer Ingelheim Investigational Site
Marikina, Philippines
1218.65.63002 Boehringer Ingelheim Investigational Site
San Juan, Philippines
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01215097     History of Changes
Other Study ID Numbers: 1218.65
First Posted: October 6, 2010    Key Record Dates
Results First Posted: June 3, 2013
Last Update Posted: August 25, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action