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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01512979
First received: January 16, 2012
Last updated: May 12, 2014
Last verified: May 2014

January 16, 2012
May 12, 2014
January 2012
April 2013   (final data collection date for primary outcome measure)
Change From Baseline in HbA1c After 24 Weeks [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
HbA1c is measured as a percentage. The change from baseline is the Week 24 HbA1c minus the baseline HbA1c. Means are adjusted for treatment and continuous baseline HbA1c
Change from baseline in HbA1c [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01512979 on ClinicalTrials.gov Archive Site
  • 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 is the FPG after 24 weeks minus the baseline FPG. Means are adjusted for treatment, continuous baseline HbA1c and continuous baseline fasting plasma glucose.
  • Change From Baseline in HbA1c by Visit Over Time [ Time Frame: Baseline, 6, 12, 18 and 24 weeks ] [ Designated as safety issue: No ]
    HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes treatment, continuous baseline HbA1c in addition to week repeated within patient, week by baseline HbA1c interaction and week by treatment interaction.
  • Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment) [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    The proportion of patients who achieved HbA1c lowering by at least 0.5% after 24 weeks of treatment.The model includes treatment, and continuous baseline HbA1c.
  • Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 1.0% After 24 Weeks of Treatment) [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    The proportion of patients who achieved HbA1c lowering by at least 1.0% after 24 weeks of treatment. The model includes treatment, and continuous baseline HbA1c.
  • Occurrence of Treat to Target Efficacy Response (HbA1c <7.0%) After 24 Weeks of Treatment [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    The proportion of patients who achieved HbA1c below 7.0% after 24 weeks of treatment. The model includes treatment, and continuous baseline HbA1c.
  • Change From Baseline in FPG by Visit Over Time [ Time Frame: Baseline, 6, 12, 18 and 24 weeks ] [ Designated as safety issue: No ]
    The change from baseline is the FPG over time minus the baseline FPG. Means are adjusted for treatment, continuous baseline HbA1c, continuous baseline FPG in addition to week repeated within patient, week by baseline FPG interaction and week by treatment interaction.
  • Change from baseline in FPG after 24 weeks of treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in HbA1c by visit over time [ Time Frame: 6, 12, 18 and 24 weeks ] [ Designated as safety issue: No ]
  • Occurrence of relative efficacy response (HbA1c lowering by a least 0.5% after 24 weeks of treatment) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Occurrence of relative efficacy response (HbA1c lowering by a least 1.0% after 24 weeks of treatment) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Occurrence of treat to target efficacy response (HbA1c <7.0%) after 24 weeks of treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in FPG by visit over time [ Time Frame: 6, 12, 18 and 24 weeks ] [ Designated as safety issue: No ]
  • Body weight: Change from baseline to Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • HOMA indices for insulin resistance and insulin secretion (at baseline and Week 24) [ Time Frame: after 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Linagliptin and Metformin Versus Linagliptin in Newly Diagnosed, Untreated Type 2 Diabetes
A 24-week, Randomized, Double-blind, Active-controlled, Parallel Group Trial to Assess the Superiority of Oral Linagliptin and Metformin Compared to Linagliptin Monotherapy in Newly Diagnosed, Treatment-naïve, Uncontrolled Type 2 Diabetes Mellitus Patients

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: metformin
    1000 mg to 2000 mg per day
  • Drug: linagliptin
    5 mg daily
  • Drug: metformin placebo
    0 to 2 tablets daily
  • Drug: metformin placebo
    4 tablets daily
  • Experimental: linagliptin
    patients receive linagliptin tablet once daily
    Interventions:
    • Drug: linagliptin
    • Drug: metformin placebo
  • Experimental: linagliptin plus metformin
    patients receive linagliptin tablet once daily and metformin tablets twice daily
    Interventions:
    • Drug: metformin
    • Drug: linagliptin
    • Drug: metformin placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
316
April 2013
April 2013   (final data collection date for primary outcome measure)

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.).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation,   United States,   Puerto Rico,   Canada,   Ukraine,   Mexico,   Malaysia,   Philippines,   Thailand,   India,   Sri Lanka,   Israel
 
NCT01512979
1218.83, 2011-004158-24
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
May 2014

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