A Study of the Safety and Effectiveness of a R256918 in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00672386
First received: May 2, 2008
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Nutritional and Metabolic Diseases
Drug: JNJ16269110
Drug: Placebo
Drug: Metformin
Other: Dietary Counseling
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Mean change in HbA1c from baseline to week 12 [ Time Frame: baseline, week 4, 6, 8, 10 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in fasting plasma glucose [ Time Frame: every 2 weeks ] [ Designated as safety issue: No ]
  • Changes in body weight [ Time Frame: every 2 weeks ] [ Designated as safety issue: No ]
  • Changes in plasma lipids [ Time Frame: baseline, week 6 and 12 ] [ Designated as safety issue: No ]
  • Changes in systolic and diastolic blood pressure [ Time Frame: every 2 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 352
Study Start Date: December 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
JNJ16269110 5 mg twice daily for 12 weeks
Drug: JNJ16269110
5 mg twice daily for 12 weeks
Drug: Metformin
Participants will continue taking metformin at the same dose and according to the same dosing regimen as before the study.
Other: Dietary Counseling
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.
Experimental: 002
JNJ16269110 10 mg twice daily for 12 weeks
Drug: JNJ16269110
10 mg twice daily for 12 weeks
Drug: Metformin
Participants will continue taking metformin at the same dose and according to the same dosing regimen as before the study.
Other: Dietary Counseling
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.
Experimental: 003
JNJ16269110 15 mg twice daily for 12 weeks
Drug: JNJ16269110
15 mg twice daily for 12 weeks
Drug: Metformin
Participants will continue taking metformin at the same dose and according to the same dosing regimen as before the study.
Other: Dietary Counseling
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.
Placebo Comparator: 004
Placebo twice daily for 12 weeks
Drug: Placebo
twice daily for 12 weeks
Drug: Metformin
Participants will continue taking metformin at the same dose and according to the same dosing regimen as before the study.
Other: Dietary Counseling
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00672386

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Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00672386     History of Changes
Other Study ID Numbers: CR013051, CR013051
Study First Received: May 2, 2008
Last Updated: July 10, 2014
Health Authority: United States: Institutional Review Board
Denmark: Danish Medicines Agency
Great Britain: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Diabetes
Type 2 Diabetes
Adult-Onset Diabetes Mellitus
Metabolic Syndrome
HbA1c
Body Weight
Metformin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Metabolic Diseases
Glucose Metabolism Disorders
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014