Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients
This study is currently recruiting participants.
Verified May 2013 by Boehringer Ingelheim Pharmaceuticals
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01708902
First received: October 16, 2012
Last updated: May 15, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
factorial design study with 26 week randomised placebo-controlled treatment with initial titration of metformin dose in metformin high dose groups
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: linagliptin2.5mg/metformin1000mg Drug: linagliptin 5mg Drug: Metformin 500mg Drug: linagliptin2.5mg/metformin500mg Drug: Metformin 1000mg |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Phase III Randomised, Double-blind, Parallel Group Study to Compare the Efficacy and Safety of Twice Daily Administration of the Fix Dose Combination of Linagliptin 2.5 mg + Metformin 500 mg, or of Linagliptin 2.5 mg + Metformin 1000 mg, With the Individual Components of Metformin (500 mg or 1000 mg, Twice Daily), and Linagliptin (5.0 mg, Once Daily) Over 24 Weeks in Treatment naïve Type 2 Diabetic Patients With Insufficient Glycaemic Control |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- The change from baseline in HbA1c after 24 weeks of treatment (for both in main group and additional parallel group). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of participants with clinically relevant changes in clinical laboratory values from baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- Test the occurrence of treat to target efficacy response in terms of HbA1c < 7.0 % and < 6.5% after 24 weeks of treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Test the 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 ]
- Test the change in FPG from baseline after 24 weeks of treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Test the change of Fasting Plasma Glucose(FPG) by visit over time [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Test the use of rescue therapy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Test the change of Postprandial Glucose(PPG) from baseline after 24 weeks of treatment (substudy in main group) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Incidence of Adverse events,Hypoglycaemic events and Protocol-specified significant adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 888 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: linagliptin2.5mg / metformin1000mg BID
patient to receive a tablet containing linagliptin 2.5mg and metformin 1000mg BID
|
Drug: linagliptin 5mg
linagliptin 5mg once daily
Drug: Metformin 1000mg
Metformin 1000mg BID
|
|
Active Comparator: metformin 500mg BID
patient to receive a tablet containing metformin 500mg BID
|
Drug: linagliptin2.5mg/metformin500mg
linagliptin2.5mg/metformin500mg BID
|
|
Active Comparator: metformin 1000mg BID
patient to receive a tablet containing metformin 1000mg BID
|
Drug: linagliptin2.5mg/metformin1000mg
linagliptin2.5mg/metformin1000mg BID
|
|
Active Comparator: linagliptin 5 mg QD
patient to receive a tablet containing linagliptin 5mg once daily
|
Drug: linagliptin2.5mg/metformin1000mg
linagliptin2.5mg/metformin1000mg BID
Drug: linagliptin2.5mg/metformin500mg
linagliptin2.5mg/metformin500mg BID
|
|
Experimental: linagliptin2.5mg / metformin500mg BID
patient to receive a tablet containing linagliptin 2.5mg and metformin 500mg BID
|
Drug: linagliptin 5mg
linagliptin 5mg once daily
Drug: Metformin 500mg
Metformin 500mg BID
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Diagnosis of Type 2 diabetes mellitus(T2DM) prior to informed consent
- Male and female patients on diet and exercise regimen who are drug-naïve
- Glycosylated haemoglobin A1c (HbA1c) at V1a >/=7.5 %<11% for main group and HbA1c >/= 11.0 % for the additional parallel group
- Age >/= 18 and </= 80 years at Visit 1a (Screening)
- Body Mass Index(BMI)</ = 40 kg/m2 at Visit 1a (Screening)
- Signed and dated written informed consent by date of Visit 1a in accordance with good clinical practice(GCP) and local legislation
Exclusion criteria:
- Uncontrolled hyperglycaemia required for rescue medication during placebo run-in phase
- In main group, the patients with investigational medicinal product(IMP) compliance < 80 % or >120 % during 2 weeks placebo run in period
- Acute coronary syndrome stroke or Transient ischaemic attack (TIA) within 3 months prior to randomisation
- Impaired hepatic function, defined by serum levels of either Alanine aminotransferase(ALT) ,Aspartate aminotransferase(AST), or alkaline phosphatase (AP) above 3 x upper limit of normal (ULN) ,or total bilirubin above 1.5 x ULN as determined at Visit 1a
- Known hypersensitivity or allergy to linagliptin or its excipients or metformin or placebo
- Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at the time of screening
- Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake in the opinion of the investigator.
- Concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form or during the trial.
- 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
- Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
- Renal failure or renal impairment at Visit 1a (screening) with an Estimated Glomerular Filtration Rate(eGFR) < 60 ml/min
- Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
- Dehydration by clinical judgement of the investigator
- Clinical detected unstable or acute congestive heart failure
- Acute or chronic metabolic acidosis (present in patient history)
- Hereditary galactose intolerance
- Known history of pancreatitis and chronic pancreatitis
- Any other clinical condition that would jeopardize patients safety while participating in this clinical trial at the discretion of investigator
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708902
Show 57 Study Locations
Contacts
| Contact: Boehringer Ingelheim Call Center | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Show 57 Study LocationsSponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Eli Lilly and Company
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01708902 History of Changes |
| Other Study ID Numbers: | 1288.18 |
| Study First Received: | October 16, 2012 |
| Last Updated: | May 15, 2013 |
| Health Authority: | China: Food and Drug Administration Malaysia: Ministry of Health Philippines: Bureau of Food and Drugs Vietnam: |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases BI 1356 Metformin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013