A Study of the Safety and Effectiveness of a R256918 in Patients With Type 2 Diabetes
July 10, 2014 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A 12-Week, Double-Blind, Randomized, Placebo-Controlled Study in Type 2 Diabetes Mellitus Subjects to Evaluate the Efficacy, Safety and Tolerability of MTP Inhibitor JNJ-16269110 (R256918)
The purpose of this study is to investigate the effectiveness and safety of 12 weeks of treatment with R256918 in patients with Type 2 Diabetes Mellitus who are taking metformin.
The primary measure of effectiveness is the change in concentration of glycated hemoglobin (HbA1c) during treatment.
Glycated hemoglobin is a substance in red blood cells that is formed when blood sugar (glucose) attaches to hemoglobin and is a measure of diabetic status.
Additional measures include fasting glucose, and lipid levels, and body weight.
Safety assessments performed during the trial include laboratory tests, vital sign measurements, and adverse event reporting.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a randomized (assigned study drug by chance), double-blind (both the patient and investigator do not know whether patient is assigned to receive study drug or placebo), placebo-controlled study involving patients with Type 2 Diabetes Mellitus who are taking metformin.
Patients are randomized to one of 4 treatment groups and receive study drug (R256918: 5 mg, 10 mg, or 15 mg twice daily) or placebo for a period of 12 weeks.
The study consists of a screening period, a baseline visit, the treatment period of 12 weeks, and a follow-up visit.
During the treatment period, patients visit the center every two weeks.
On each visit, patients come to the clinic after 8 hours fasting.
Effectiveness assessments from a blood sample include levels of fasting hemoglobin type A1c (HbA1c), glucose, cholesterol, triglycerides, insulin, C-peptide, and gastrointestinal hormones.
Patients monitor their fasting blood glucose and record it in a diary.
Insulin sensitivity and beta cell (insulin-producing cells in the pancreas) function are evaluated.
Waist and hip circumference are measured.
Safety evaluations, including incidence of adverse events, clinical laboratory results, vital signs, and electrocardiograms, are performed during the study.
Patients complete a questionnaire related to treatment satisfaction of study medication.
Patients receive dietary counseling and will be instructed to remain on a calorically appropriate diet with a maximum of 30 percent (%) of calories derived from fat (in accordance with local practice guidelines for the treatment of type 2 diabetes mellitus), during the entire study.
Patients continue taking metformin in the same dose and according to the same dosing regimen as before the study.
The overall duration of the study for each patient is approximately 18 weeks.
The study will evaluate the effect of R25691 on glucose-dependent insulin secretion, weight loss and changes in insulin sensitivity and tolerability in type 2 diabetic patients.
Study Type
Interventional
Enrollment (Actual)
352
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Edegem, Belgium
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Hellerup N/A, Denmark
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Vipperroed, Denmark
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Helsinki, Finland
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Hyvinkaa, Finland
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Kuopio, Finland
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Oulu, Finland
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Berlin Buch, Germany
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Dresden, Germany
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Düsseldorf, Germany
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Hamburg, Germany
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Mainz, Germany
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Munchen, Germany
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Ulm, Germany
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Bangalore, India
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Chennai, India
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Hyderabad, India
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Mumbai, India
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Nagpur, India
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Pune, India
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Breda, Netherlands
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Eindhoven, Netherlands
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Leiden, Netherlands
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Nijmegen, Netherlands
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Rotterdam, Netherlands
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Velp Gld, Netherlands
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Zoetermeer, Netherlands
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Oslo, Norway
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Paradis N/A, Norway
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Bialystok, Poland
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Bydgoszcz, Poland
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Elblag, Poland
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Kutno 001, Poland
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Lodz, Poland
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Olsztyn, Poland
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Pruszkow, Poland
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Torun, Poland
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Warszawa, Poland
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Wroclaw, Poland
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Zielona Gora, Poland
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Moscow, Russian Federation
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Saratov, Russian Federation
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St Petersburg N/A, Russian Federation
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St-Petersburg, Russian Federation
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Göteborg, Sweden
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Härnösand, Sweden
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Linköping, Sweden
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Lund, Sweden
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Stockholm, Sweden
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Ängelholm N/A, Sweden
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Örebro, Sweden
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Bangor, United Kingdom
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Belfast, United Kingdom
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Birmingham, United Kingdom
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Cambridge, United Kingdom
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Cardiff, United Kingdom
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Clydebank, United Kingdom
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Dundee, United Kingdom
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Liverpool, United Kingdom
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London, United Kingdom
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Randalstown, United Kingdom
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Reading, United Kingdom
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Salford, United Kingdom
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- History of Type 2 Diabetes Mellitus and treated with a stable dose of metformin for at least 2 months
- Women must be postmenopausal or surgically incapable of childbearing or if sexually active, be practicing an effective method of birth control
- BMI between 25 and 45 kg/m2
- HbA1c between 7% and 10%, inclusive
- Fasting plasma glucose not exceeding 240mg/dL (13.3mmol/L)
Exclusion Criteria:
- Diabetes other than type 2 diabetes mellitus
- Treatment with oral anti-diabetic agents (other than metformin) or insulin during the 12 weeks before baseline visit
- History of intolerance or hypersensitivity to sulfonylurea or sitagliptin
- History of clinically significant gastrointestinal, hepatic or cardiovascular disease
- Active proliferative diabetic retinopathy
- History of diabetic gastroparesis
- concurrent use of systemic corticosteroid
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 001
JNJ16269110 5 mg twice daily for 12 weeks
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5 mg twice daily for 12 weeks
10 mg twice daily for 12 weeks
15 mg twice daily for 12 weeks
Participants will continue taking metformin at the same dose and according to the same dosing regimen as before the study.
Participants will receive dietary counseling at Screening, Week 4, 8, 12, and will be instructed to remain on a calorically appropriate diet with a maximum of 30% of calories derived from fat (in accordance with local practice guidelines for the treatment of type 2 diabetes mellitus) during the entire study.
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Experimental: 002
JNJ16269110 10 mg twice daily for 12 weeks
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5 mg twice daily for 12 weeks
10 mg twice daily for 12 weeks
15 mg twice daily for 12 weeks
Participants will continue taking metformin at the same dose and according to the same dosing regimen as before the study.
Participants will receive dietary counseling at Screening, Week 4, 8, 12, and will be instructed to remain on a calorically appropriate diet with a maximum of 30% of calories derived from fat (in accordance with local practice guidelines for the treatment of type 2 diabetes mellitus) during the entire study.
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Experimental: 003
JNJ16269110 15 mg twice daily for 12 weeks
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5 mg twice daily for 12 weeks
10 mg twice daily for 12 weeks
15 mg twice daily for 12 weeks
Participants will continue taking metformin at the same dose and according to the same dosing regimen as before the study.
Participants will receive dietary counseling at Screening, Week 4, 8, 12, and will be instructed to remain on a calorically appropriate diet with a maximum of 30% of calories derived from fat (in accordance with local practice guidelines for the treatment of type 2 diabetes mellitus) during the entire study.
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Placebo Comparator: 004
Placebo twice daily for 12 weeks
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Participants will continue taking metformin at the same dose and according to the same dosing regimen as before the study.
Participants will receive dietary counseling at Screening, Week 4, 8, 12, and will be instructed to remain on a calorically appropriate diet with a maximum of 30% of calories derived from fat (in accordance with local practice guidelines for the treatment of type 2 diabetes mellitus) during the entire study.
twice daily for 12 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Mean change in HbA1c from baseline to week 12
Time Frame: baseline, week 4, 6, 8, 10 and 12
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baseline, week 4, 6, 8, 10 and 12
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Changes in fasting plasma glucose
Time Frame: every 2 weeks
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every 2 weeks
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Changes in body weight
Time Frame: every 2 weeks
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every 2 weeks
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Changes in plasma lipids
Time Frame: baseline, week 6 and 12
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baseline, week 6 and 12
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Changes in systolic and diastolic blood pressure
Time Frame: every 2 weeks
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every 2 weeks
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Changes in insulin sensitivity and beta cell function (homeostatic model assessment 2 - HOMA-2 and MMTT); Changes in GLP-1 (glucagon-like peptide 1) and PYY (peptide tyrosine tyrozine) levels in the MMTT; Changes in insulin and glucagon
Time Frame: baseline and Week 12
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baseline and Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
May 2, 2008
First Submitted That Met QC Criteria
May 2, 2008
First Posted (Estimate)
May 6, 2008
Study Record Updates
Last Update Posted (Estimate)
July 14, 2014
Last Update Submitted That Met QC Criteria
July 10, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR013051
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.