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Diabetes Mellitus, Type 2Phase 2NCT00672386

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

A Phase 2 study testing JNJ16269110, Metformin and Dietary Counseling in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 62 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
JNJ16269110, Metformin and Dietary Counseling
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
352 participants
Where
62 sitesin 11 countries
Study dates
Dec 2007to Sep 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

62 sites in 11 countries.

62 sites in 11 countries

United Kingdom12 sites

  • Study site

    Bangor

  • Study site

    Belfast

  • Study site

    Birmingham

  • Study site

    Cambridge

  • Study site

    Cardiff

  • Study site

    Clydebank

  • Study site

    Dundee

  • Study site

    Liverpool

  • Study site

    London

  • Study site

    Randalstown

  • Study site

    Reading

  • Study site

    Salford

Other trials in United Kingdom

Poland11 sites

  • Study site

    Bialystok

  • Study site

    Bydgoszcz

  • Study site

    Elblag

  • Study site

    Kutno

  • Study site

    Lodz

  • Study site

    Olsztyn

  • Study site

    Pruszków

  • Study site

    Torun

  • Study site

    Warsaw

  • Study site

    Wroclaw

  • Study site

    Zielona Góra

Other trials in Poland

Germany7 sites

  • Study site

    Buch

  • Study site

    Dresden

  • Study site

    Düsseldorf

  • Study site

    Hamburg

  • Study site

    Mainz

  • Study site

    München

  • Study site

    Ulm

Other trials in Germany

Netherlands7 sites

  • Study site

    Breda

  • Study site

    Eindhoven

  • Study site

    Leiden

  • Study site

    Nijmegen

  • Study site

    Rotterdam

  • Study site

    Velp Gld

  • Study site

    Zoetermeer

Other trials in Netherlands

Sweden7 sites

  • Study site

    Ängelholm

  • Study site

    Gothenburg

  • Study site

    Härnösand

  • Study site

    Linköping

  • Study site

    Lund

  • Study site

    Örebro

  • Study site

    Stockholm

Other trials in Sweden

India6 sites

  • Study site

    Bangalore

  • Study site

    Chennai

  • Study site

    Hyderabad

  • Study site

    Mumbai

  • Study site

    Nagpur

  • Study site

    Pune

Other trials in India

Finland4 sites

  • Study site

    Helsinki

  • Study site

    Hyvinkää

  • Study site

    Kuopio

  • Study site

    Oulu

Other trials in Finland

Russia3 sites

  • Study site

    Moscow

  • Study site

    Saint Petersburg

  • Study site

    Saratov

Other trials in Russia

Denmark2 sites

  • Study site

    Hellerup

  • Study site

    Vipperroed

Other trials in Denmark

Norway2 sites

  • Study site

    Oslo

  • Study site

    Paradis

Other trials in Norway

Belgium1 site

  • Study site

    Edegem

Other trials in Belgium

About this study

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)

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.

Read the 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.

Being tested
JNJ16269110, Placebo, Metformin, Dietary Counseling
Keywords
Diabetes, Type 2 Diabetes, Adult-Onset Diabetes Mellitus, Metabolic Syndrome, HbA1c, Body Weight, Metformin
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus, Endocrine System Diseases, Nutritional and Metabolic Diseases, Metabolic Syndrome, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ16269110Drug

    5 mg twice daily for 12 weeks

  • JNJ16269110Drug

    10 mg twice daily for 12 weeks

  • JNJ16269110Drug

    15 mg twice daily for 12 weeks

  • PlaceboDrug

    twice daily for 12 weeks

  • MetforminDrug

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

  • Dietary CounselingOther

    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.

Study groups in NCT00672386
Study groupRoleWhat they receive
001ExperimentalJNJ16269110 5 mg twice daily for 12 weeks
Receives: Drug: JNJ16269110; Drug: Metformin; Other: Dietary Counseling
002ExperimentalJNJ16269110 10 mg twice daily for 12 weeks
Receives: Drug: JNJ16269110; Drug: Metformin; Other: Dietary Counseling
003ExperimentalJNJ16269110 15 mg twice daily for 12 weeks
Receives: Drug: JNJ16269110; Drug: Metformin; Other: Dietary Counseling
004Placebo comparatorPlacebo twice daily for 12 weeks
Receives: Drug: Placebo; Drug: Metformin; Other: Dietary Counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change in HbA1c from baseline to week 12

    Measured: baseline, week 4, 6, 8, 10 and 12

Secondary outcomes (5)

  1. Changes in fasting plasma glucose

    Measured: every 2 weeks

  2. Changes in body weight

    Measured: every 2 weeks

  3. Changes in plasma lipids

    Measured: baseline, week 6 and 12

  4. Changes in systolic and diastolic blood pressure

    Measured: every 2 weeks

  5. 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

    Measured: baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2008 (estimated)
  2. Study startDec 2007
  3. Primary completionSep 2008
  4. Study completionSep 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
352 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00672386
Sponsor's protocol ID
CR013051
Other IDs
CR013051
Status last verified
Jul 2014
First submitted
2 May 2008
Last updated
14 Jul 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JNJ16269110, Metformin and Dietary Counseling in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 62 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United Kingdom, Poland, Germany, Netherlands, Sweden and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change in HbA1c from baseline to week 12 (time frame: baseline, week 4, 6, 8, 10 and 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00672386.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2014.

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