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

NCT ID: NCT00672386

Last Updated: 2014-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 352 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2008-09-30

Brief Summary

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.

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.

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Endocrine System Diseases; Nutritional and Metabolic Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

001

JNJ16269110 5 mg twice daily for 12 weeks

Group Type: EXPERIMENTAL

JNJ16269110

Intervention Type: DRUG

5 mg twice daily for 12 weeks

Metformin

Intervention Type: DRUG

Participants will continue taking metformin at the same dose and according to the same dosing regimen as before the study.

Dietary Counseling

Intervention Type: OTHER

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.

002

JNJ16269110 10 mg twice daily for 12 weeks

Group Type: EXPERIMENTAL

JNJ16269110

Intervention Type: DRUG

10 mg twice daily for 12 weeks

Metformin

Intervention Type: DRUG

Participants will continue taking metformin at the same dose and according to the same dosing regimen as before the study.

Dietary Counseling

Intervention Type: OTHER

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.

003

JNJ16269110 15 mg twice daily for 12 weeks

Group Type: EXPERIMENTAL

JNJ16269110

Intervention Type: DRUG

15 mg twice daily for 12 weeks

Metformin

Intervention Type: DRUG

Participants will continue taking metformin at the same dose and according to the same dosing regimen as before the study.

Dietary Counseling

Intervention Type: OTHER

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.

004

Placebo twice daily for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

twice daily for 12 weeks

Metformin

Intervention Type: DRUG

Participants will continue taking metformin at the same dose and according to the same dosing regimen as before the study.

Dietary Counseling

Intervention Type: OTHER

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.

Interventions

JNJ16269110

5 mg twice daily for 12 weeks

Intervention Type: DRUG

JNJ16269110

10 mg twice daily for 12 weeks

Intervention Type: DRUG

JNJ16269110

15 mg twice daily for 12 weeks

Intervention Type: DRUG

Placebo

twice daily for 12 weeks

Intervention Type: DRUG

Metformin

Participants will continue taking metformin at the same dose and according to the same dosing regimen as before the study.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

Edegem, , Belgium

Hellerup, , Denmark

Vipperroed, , Denmark

Helsinki, , Finland

Hyvinkää, , Finland

Kuopio, , Finland

Oulu, , Finland

Buch, , Germany

Dresden, , Germany

Düsseldorf, , Germany

Hamburg, , Germany

Mainz, , Germany

München, , Germany

Ulm, , Germany

Bangalore, , India

Chennai, , India

Hyderabad, , India

Mumbai, , India

Nagpur, , India

Pune, , India

Breda, , Netherlands

Eindhoven, , Netherlands

Leiden, , Netherlands

Nijmegen, , Netherlands

Rotterdam, , Netherlands

Velp Gld, , Netherlands

Zoetermeer, , Netherlands

Oslo, , Norway

Paradis, , Norway

Bialystok, , Poland

Bydgoszcz, , Poland

Elblag, , Poland

Kutno, , Poland

Lodz, , Poland

Olsztyn, , Poland

Pruszków, , Poland

Torun, , Poland

Warsaw, , Poland

Wroclaw, , Poland

Zielona Góra, , Poland

Moscow, , Russia

Saint Petersburg, , Russia

Saratov, , Russia

Ängelholm, , Sweden

Gothenburg, , Sweden

Härnösand, , Sweden

Linköping, , Sweden

Lund, , Sweden

Örebro, , Sweden

Stockholm, , Sweden

Bangor, , United Kingdom

Belfast, , United Kingdom

Birmingham, , United Kingdom

Cambridge, , United Kingdom

Cardiff, , United Kingdom

Clydebank, , United Kingdom

Dundee, , United Kingdom

Liverpool, , United Kingdom

London, , United Kingdom

Randalstown, , United Kingdom

Reading, , United Kingdom

Salford, , United Kingdom

Countries

Belgium; Denmark; Finland; Germany; India; Netherlands; Norway; Poland; Russia; Sweden; United Kingdom

Other Identifiers

CR013051

Identifier Type: -

Identifier Source: secondary_id

CR013051

Identifier Type: -

Identifier Source: org_study_id