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Diabetes Type 2Phase 3NCT00684528

A Double-Blind, Randomized, Active-Comparator (Metformin) Controlled, Clinical Trial to Study the Efficacy and Safety of the Strategy to Start Patients With Type 2 Diabetes Mellitus on Janumet™ Compared to Metformin

A Phase 3 study testing Metformin 1500 mg daily and Metformin + Janufer (Janumet) in people with Diabetes Type 2, run by Meir Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Comparison between the effectiveness of one anti-diabetic drug (Metformin, To combination of this drug and additional drug (Janufer), In the community setting. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Type 2
What is being tested?
Metformin 1500 mg daily and Metformin + Janufer (Janumet)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
1 siteIsrael
Study dates
Jun 2008to Dec 2012
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All laboratory measurements are to be performed after an overnight fast ≥ 10 hours in duration. Patients with laboratory screening values/findings not meeting protocol inclusion criteria may, at the discretion of the investigator, have one repeat determination performed. If the repeat value satisfies the criterion they may continue in the screening process. Only the laboratory test not meeting inclusion should be repeated (not the entire panel).

Who cannot join

  • Glucose Metabolism and Therapy Criteria
  • Patient has a history of type 1 diabetes mellitus or history of ketoacidosis. Patients Requiring Specific Treatments
  • Patient has symptomatic hyperglycemia requiring immediate initiation of insulin therapy.
  • Patient has a history of intolerance or hypersensitivity to metformin or sitagliptin or has any contraindication to use metformin.
  • Concomitant Disease of Organs and Systems
  • Patient has a medical history of active liver disease (excluding hepatic steatosis).
Show all 18Show fewer
  • Patient has severe active peripheral vascular disease (e.g., manifested by claudication with minimal activity, a non-healing ischemic ulcer, or disease which is likely to require intervention such as with bypass or angioplasty).
  • Patient has unstable or acute congestive heart failure.
  • Patient has a history of malignancy without documentation of remission/cure. Other Criteria
  • Patient is pregnant, has a positive urine pregnancy test at Visit 1, is expecting to conceive within the projected duration of the study, or is breast feeding.
  • Patient has increased serum-creatinine and/or decreased estimated creatinine clearance.
  • If screening labs are repeated, the last laboratory draw/result should be used for inclusion.§ Either elevated Creatinine or decreased estimated creatinine clearance lead to exclusion of the patient.
  • Patients whose serum creatinine does not meet the exclusion criteria, but whose estimated creatinine clearance is <60 mL/min but ≥50 mL/min, may have a measured creatinine clearance (i.e., based upon a 24-hour urine collection). These patients may be eligible if their measured creatinine clearance is ≥60 mL/min.
  • At Visit 2
  • Patient has a site fingerstick glucose <130 mg/dL (7.2 mmol/L) or >320 mg/dL (17.8 mmol/L).
  • Note: If the patient meets this exclusion criterion AND the investigator believes that the value does not reflect the patient's recent glycemic control based upon recent SBGM values and/or the Visit 1 FPG value, the patient should not be excluded at this time. The current visit should be changed to an "Unscheduled visit" and the patient should be rescheduled for Visit 2. If, at the rescheduled Visit 2, the patient meets this exclusion criterion, the patient MUST be excluded.
  • Patient has a positive urine pregnancy test.
  • Patient developed a new medical condition, suffered a change in status of an established medical condition, developed a laboratory abnormality, or required a new treatment or medication between Visit 1 and Visit 2 which meets any previously described study exclusion criterion.

Trial locations and contacts

1 site in 1 country.

Niky Liberman, MD contact

972-3692-3316

nikyli@clalit.org.il

Lotan Shilo, MD contact

972-9747-2170

shilolo@clalit.org.il

Israel1 site, 1 recruiting

  • Clalit Health services center

    Tel Aviv, 62098

    Zinger, 972-5062-63652

    Zinger Joel, MD

    Recruiting

Other trials in Israel

About this study

Comparison between the effectiveness of one anti-diabetic drug (Metformin, To combination of this drug and additional drug (Janufer), In the community setting.

Read the detailed description

This is a randomized, double-blind, active-comparator (metformin) controlled study in drug-naïve patients with T2DM who have an HbA1c ≥ 7.5%. The duration of the study is 55 weeks, which will include a 1-week screening period (Visit 1 to Visit 2) and a 54 week double-blind, active treatment period. At Visit 2/Day 1 patients who meet all enrollment criteria will be randomized in a 1:1 ratio to one of two active treatment groups: 1. JANUMET™ (fixed-dose combination sitagliptin/metformin) or 2. metformin. The starting fixed-dose combination of sitagliptin/metformin will be 50/500 mg administered twice-daily and then up-titrated to a dose of 50/1000 mg b.i.d. over 4 weeks. The starting dose of metformin will be 500 mg twice-daily and then up-titrated to a dose of 1000 mg b.i.d. over 4 weeks. Patients who can not tolerate JANUMET™ at a dose of at least 50/500 mg b.i.d. or metformin at a dose of at least 500 mg b.i.d. 6 weeks after randomization and throughout the study will be discontinued. During the double-blind treatment period patients will remain on the study medication, but investigators are allowed to add other antihyperglycemic agents to improve glycemic control as necessary. The investigator can schedule additional visits to initiate additional antihyperglycemic agents or monitor glycemic control at any time during the study period. There will be no fixed visit schedule, but 7 clinical visits are recommended. It is also recommended to perform the first visit on active treatment 6 weeks after randomization and after this visit to schedule visits every 3 months. All clinical and lab data can be obtained using the "Clalit health care information system".

Conditions
Diabetes Type 2
Being tested
Metformin 1500 mg daily, Metformin + Janufer (Janumet)
Keywords
DM 2, Metformin, Januvia, Community setting, newly diagnosed diadetics, or diabetes patients not treated during the last year
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • Metformin 1500 mg dailyDrug

    500 mg thrice daily

  • Metformin + Janufer (Janumet)Drug

    Titration up to 1500/150 mg daily

Study groups in NCT00684528
Study groupRoleWhat they receive
aActive comparatorThis group will receive Metformin and placebo.
Receives: Drug: Metformin 1500 mg daily
2ExperimentalThe second arm will receive Metformin and Januvia
Receives: Drug: Metformin 1500 mg daily; Drug: Metformin + Janufer (Janumet)

What is being measured

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

  1. The efficacy and safety of community based study in diabetic patients, comparing Metformin to Metformin + Janufer.

    Measured: 54 weeks

  2. The efficacy and safety of Metformin VS Metformin + Janufer in the community setting

    Measured: 2010

Timeline

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

  1. First posted26 May 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionDec 2011
  4. Study completionDec 2012 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00684528
Sponsor's protocol ID
jfr_il0801
Status last verified
Mar 2012
First submitted
21 May 2008
Last updated
19 Mar 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Mistry GC, Maes AL, Lasseter KC, Davies MJ, Gottesdiener KM, Wagner JA, Herman GA. Effect of sitagliptin, a dipeptidyl peptidase-4 inhibitor, on blood pressure in nondiabetic patients with mild to moderate hypertension. J Clin Pharmacol. 2008 May;48(5):592-8. doi: 10.1177/0091270008316885. Epub 2008 Mar 19.

    PubMed 18353996

  • Scott R, Loeys T, Davies MJ, Engel SS; Sitagliptin Study 801 Group. Efficacy and safety of sitagliptin when added to ongoing metformin therapy in patients with type 2 diabetes. Diabetes Obes Metab. 2008 Sep;10(10):959-69. doi: 10.1111/j.1463-1326.2007.00839.x. Epub 2008 Jan 14.

    PubMed 18201203

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Metformin 1500 mg daily and Metformin + Janufer (Janumet) in people with Diabetes Type 2, run by Meir Medical Center at 1 site in Israel.

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 1 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 19 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Niky Liberman, MD (972-3692-3316, nikyli@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The efficacy and safety of community based study in diabetic patients, comparing Metformin to Metformin + Janufer. (time frame: 54 weeks). The study lists 2 primary outcomes in all. 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 NCT00684528, which also lists 2 linked publications.

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 19 Mar 2012.

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