Home » Trials » SLCTR/2012/004
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 Patient
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SLCTR Registration Number
SLCTR/2012/004
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
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 Patient
Public Title of Trial
Linaglitpin and Metformin Versus Linagliptin in Newly Diagnosed, Untreated Type 2 Diabetes
Disease or Health Condition(s) Studied
Diabetes Mellitus, Type 2
Scientific Acronym
None
Public Acronym
None
Brief title
Linaglitpin and Metformin Versus Linagliptin in Newly Diagnosed, Untreated Type 2 Diabetes
Universal Trial Number
.None
Any other number(s) assigned to the trial and issuing authority
NCT01512979 (clinicaltrials.gov), CTRI – REF/2012/03/003394, Eudra-CT-2011-004158-24
What is the research question being addressed?
To determine whether initial combination of linagliptin and metformin compared to linagliptin alone for 6 months is effective in newly diagnosed, treatment-naïve patients with Type 2 Diabetes. ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 3
Intervention(s) planned
Drug: metformin - 1000 mg to 2000 mg per day, Drug: linagliptin - 5 mg daily, Drug: linagliptin medium dose - 5 mg daily, Drug: metformin placebo - placebo daily, Drug: metformin placebo - 0 to 2 tablets daily
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. Glycated haemoglobin (HbA1c) between 8.5% and 12.0% at Visit 1 (Screen). 5. 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 (NSTEMI, STEMI, and unstable angina), stroke or transient ischemic attack within 3 months prior to informed consent. 2. 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 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, 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.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.).
Primary outcome(s)
1.
Change from baseline in HbA1c |
[ Time Frame: 24 weeks ] |
Secondary outcome(s)
1.
Change from baseline in FPG after 24 weeks of treatment |
[ Time Frame: 24 weeks ] |
2.
Change from baseline in HbA1c by visit over time |
[ Time Frame: 6, 12, 18 and 24 weeks ] |
3.
Occurrence of relative efficacy response (HbA1c lowering by a least 0.5% after 24 weeks of treatment) |
[ Time Frame: 24 weeks ] |
4.
Occurrence of relative efficacy response (HbA1c lowering by a least 1.0% after 24 weeks of treatment) |
[ Time Frame: 24 weeks ] |
5.
Occurrence of treat to target efficacy response (HbA1c <7.0%) after 24 weeks of treatment |
[ Time Frame: 24 weeks ] |
6.
Change from baseline in FPG by visit over time |
[ Time Frame: 6, 12, 18 and 24 weeks ] |
7.
Body weight: Change from baseline to Week 24 |
[ Time Frame: 24 weeks ] |
8.
HOMA indices for insulin resistance and insulin secretion (at baseline and Week 24) |
[ Time Frame: after 24 weeks ] |
Target number/sample size
50
Countries of recruitment
Canada, Estonia, Guatemala, India, Israel, Malaysia, Mexico, Philippines, Poland, Russian Federation, Slovakia, Sri Lanka, Thailand, Ukraine, United States
Anticipated start date
2012-05-04
Anticipated end date
2013-04-30
Date of first enrollment
2012-05-23
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
Boehringer Ingelheim India (Pvt) Ltd
Regulatory approvals
Status
Approved
Date of Approval
2012-01-18
Approval number
Not Available
Details of Ethics Review Committee
Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
Telephone: | +94-11-2961267 |
Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Ms. Anjalli Ajgaonke
Team Leader – Clinical Operations
Boehringer Ingelheim India Pvt Ltd, 1102, Hallmark Business Plaza, Near Gurunanak Hospital, Bandra (E), Mumbai 400051
912226456477 912226456163
anjalli.ajgaonker.ext@boehringer-ingelheim.com
Contact Person for Public Queries
Prof. Dr Asita De Silva
Director
Clinical Trials Unit, Faculty of Medicine, University of Kelaniya
94112662166 94112665300
asitades@gmail.com
Primary study sponsor/organization
Boehringer Ingelheim India (Pvt) Ltd
1102, 11th Floor, Hallmark Business Plaza, Near Gurunanak Hospital, Bandra (E), Mumbai 400051, India
912226456477 912226456163
partha.gokhale@boehringer-ingelheim.com
www.boehringer-ingelheim.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results