Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes Patients

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00328172
First received: May 18, 2006
Last updated: February 15, 2014
Last verified: February 2014
  Purpose

The objective of the current study is to investigate the efficacy, safety and tolerability of several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition, there will be an open-label treatment arm with metformin for sensitivity measurement with this patient population. Population pharmacokinetics of BI 1356 BS will also be assessed in this study.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Placebo
Drug: BI 1356 dose 3 once daily
Drug: BI 1356 dose 2 once daily
Drug: BI 1356 dose 1 once daily
Drug: Metformin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Five Parallel Group Study Investigating the Efficacy and Safety of BI 1356 BS (0.5 mg, 2.5 mg and 5.0 mg Administered Orally Once Daily) Over 12 Weeks in Drug Naive and Treated Patients With Type 2 Diabetes With Insufficient Glycemic Control (Study Includes an Open-label Metformin Treatment Arm)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 12 [ Time Frame: Baseline, week 12 ] [ Designated as safety issue: No ]
    The change from baseline reflects the Week 12 HbA1c minus the Week 0 HbA1c. Means are adjusted for baseline HbA1c.


Secondary Outcome Measures:
  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 [ Time Frame: Baseline, week 12 ] [ Designated as safety issue: No ]
    Change from baseline reflects the Week 12 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG.

  • Percentage of Patients With Absolute Efficacy Response (HbA1c <= 7.0%) at 12 Weeks [ Time Frame: Baseline, week 12 ] [ Designated as safety issue: No ]
    An absolute efficacy response is defined as HbA1c <= 7.0% at 12 weeks. A non-response is defined as HbA1c > 7.0% at 12 weeks.


Enrollment: 302
Study Start Date: May 2006
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo tablets matching BI 1356
Drug: Placebo
Placebo matching BI 1356
Experimental: BI 1356 0.5 mg
BI 1356 dose 1 once daily
Drug: BI 1356 dose 1 once daily
BI 1356 dose 1 once daily
Experimental: BI 1356 2.5 mg
BI 1356 dose 2 once daily
Drug: BI 1356 dose 2 once daily
BI 1356 dose 2 once daily
Experimental: BI 1356 5.0 mg
BI 1356 dose 3 once daily
Drug: BI 1356 dose 3 once daily
BI 1356 dose 3 once daily
Active Comparator: Metformin
Metformin
Drug: Metformin
Metformin

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Male and female patients with a diagnosis of Type 2 diabetes treated only with diet and exercise (drug naïve) or with one or two oral hypoglycemic agents (as single treatment or in combination) other than rosiglitazone or pioglitazone -treatment. Antidiabetic therapy has to be stable for at least 10 weeks prior to screening.
  2. Diagnosis of Type 2 diabetes with duration of at least 3 months
  3. Glycosylated haemoglobin A1 (HbA1c) of:

    7.5-10.0% at screening for drug naïve patients (no wash-out needed) 7.0-9.0% at screening for patients treated with only one oral antidiabetic agent (wash-out required) 6.5-8.0% at screening for patients treated with two oral antidiabetic agents (wash-out required)

  4. HbA1c of 7.5%-10.0% at Visit 3 (beginning of the 2-week placebo run-in period).
  5. Age >=21 and <=75 years.
  6. BMI (Body Mass Index) >=25.0 and <=40 kg/m2.
  7. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion criteria:

  1. Clinically relevant cardiovascular disease (e.g., myocardial infarction, stroke or transient ischemic attack within six months before enrollment)
  2. Impaired hepatic function defined by serum levels of either alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase above 3-fold upper limit of normal
  3. Renal insufficiency or impaired renal function defined by serum creatinine above upper limit of normal at screening
  4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or clinically relevant neurologic disorders (including cerebrovascular but with the exception of polyneuropathy) that would interfere with participation in the trial
  5. Chronic or clinically relevant acute infections (e.g., Human immunodeficiency virus, Hepatitis)
  6. History of relevant allergy/hypersensitivity that would interfere with trial participation (including allergy to investigational product or its excipients)
  7. Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
  8. Treatment with insulin within 3 months prior to screening
  9. Alcohol or drug abuse within the last 3 months that would interfere with trial participation)
  10. Participation in another trial with an investigational drug within two months prior to administration or during the trial
  11. Fasting plasma glucose >240 mg/dl (= 13.3 mmol/L) at Visit 2, 3 or 4 any visit and confirmed by a second measurement (not on the same day)
  12. Pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who:

    1. are not surgically sterile,
    2. or are nursing or pregnant;
    3. 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, oral, implantable or injectable contraceptives and vasectomised partner. No exception will be made.
  13. Intolerance of metformin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328172

  Show 71 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00328172     History of Changes
Other Study ID Numbers: 1218.5
Study First Received: May 18, 2006
Results First Received: May 13, 2011
Last Updated: February 15, 2014
Health Authority: Australia: Responsilble Ethics Committee
Canada: Health Canada (TPD)
Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10
Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 20, 2014