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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01215097
First received: September 28, 2010
Last updated: December 5, 2013
Last verified: June 2013

September 28, 2010
December 5, 2013
October 2010
April 2012   (final data collection date for primary outcome measure)
HbA1c Change From Baseline at Week 24 [ Time Frame: Baseline and at week 24 ] [ Designated as safety issue: No ]
Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
the change from baseline in HbA1c (HbA1c after 24 weeks of treatment) in all patients with baseline. [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01215097 on ClinicalTrials.gov Archive Site
  • HbA1c Change From Baseline at Week 6 [ Time Frame: Baseline and at week 6 ] [ Designated as safety issue: No ]
    Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
  • HbA1c Change From Baseline at Week 12 [ Time Frame: Baseline and at week 12 ] [ Designated as safety issue: No ]
    Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
  • HbA1c Change From Baseline at Week 18 [ Time Frame: Baseline and at week 18 ] [ Designated as safety issue: No ]
    Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
  • HbA1c Change From Baseline at Week 24(Chinese Only) [ Time Frame: Baseline and at 24 weeks ] [ Designated as safety issue: No ]
    Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
  • FPG Change From Baseline at Week 24 [ Time Frame: Baseline and at week 24 ] [ Designated as safety issue: No ]
    Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.
  • FPG Change From Baseline at Week 6 [ Time Frame: Baseline and at week 6 ] [ Designated as safety issue: No ]
    Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.
  • FPG Change From Baseline at Week 12 [ Time Frame: Baseline and at week 12 ] [ Designated as safety issue: No ]
    Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.
  • FPG Change From Baseline at Week 18 [ Time Frame: Baseline and at week 18 ] [ Designated as safety issue: No ]
    Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.
  • Number of Patients With HbA1c < 7.0% [ Time Frame: baseline and at week 24 ] [ Designated as safety issue: No ]
    Number of patients with HbA1c < 7.0% at week 24
  • Number of Patients With HbA1c < 7.0% at Week 24 With Baseline HbA1c >= 7.0%. [ Time Frame: baseline and at week 24 ] [ Designated as safety issue: No ]
    Number of patients with HbA1c < 7.0% at week 24 with baseline HbA1c >= 7.0%.
  • Number of Patients With HbA1c < 6.5% [ Time Frame: baseline and at week 24 ] [ Designated as safety issue: No ]
    Number of patients with HbA1c < 6.5% at week 24
  • Number of Patients With HbA1c < 6.5% at Week 24 With Baseline HbA1c >= 6.5%. [ Time Frame: baseline and at week 24 ] [ Designated as safety issue: No ]
    Number of patients with HbA1c < 6.5% at week 24 with baseline HbA1c >= 6.5%.
  • Number With HbA1c at Least Lowering 0.5% [ Time Frame: baseline and at week 24 ] [ Designated as safety issue: No ]
    Number with HbA1c at least 0.5% lowering from baseline at week 24
  • The change from baseline in HbA1c (HbA1c after 24 weeks of treatment in the subset of Chinese patients. [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
  • The occurrence of a treat to target efficacy response, that is an HbA1c under treatment of <7.0% or <6.5% after 24 weeks of treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 24 weeks of treatment) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • HbA1c reduction from baseline by visit over time [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
  • The change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
  • The change from baseline in fasting plasma glucose (FPG) by visit over time [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Use of rescue therapy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in body weight from baseline to week 24 [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Change in waist circumference from baseline to week 24 [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in lipid parameters (incl. cholesterol, LDL, HDL,triglycerides) to week 24 [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Incidence and intensity of AEs [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Withdrawal due to AEs [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Physical examination and vital signs (blood pressure and pulse) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • 12-lead ECG (clinical relevant abnormal findings) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Clinical laboratory assessments (including harmatology, clinical chemistry and urinalysis) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Linagliptin
    once a day
  • Drug: placebo
    once a day
  • Experimental: Linagliptin
    once a day
    Intervention: Drug: Linagliptin
  • Placebo Comparator: placebo
    once a day
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
306
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
China,   Malaysia,   Philippines
 
NCT01215097
1218.65
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP