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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Meir Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Clalit Health Services
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT00684528
First received: May 21, 2008
Last updated: March 16, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Diabetes Type 2
Drug: Metformin 1500 mg daily
Drug: Metformin + Janufer (Janumet)
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • The efficacy and safety of community based study in diabetic patients, comparing Metformin to Metformin + Janufer. [ Time Frame: 54 weeks ] [ Designated as safety issue: Yes ]
  • The efficacy and safety of Metformin VS Metformin + Janufer in the community setting [ Time Frame: 2010 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: June 2008
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: a
This group will receive Metformin and placebo.
Drug: Metformin 1500 mg daily
500 mg thrice daily
Experimental: 2
The second arm will receive Metformin and Januvia
Drug: Metformin 1500 mg daily
500 mg thrice daily
Drug: Metformin + Janufer (Janumet)
Titration up to 1500/150 mg daily

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".

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

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).
  • 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.

Exclusion Criteria Based on Lab Abnormalities

  • 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.
  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: NCT00684528

Contacts
Contact: Niky Liberman, MD 972-3692-3316 nikyli@clalit.org.il
Contact: Lotan Shilo, MD 972-9747-2170 shilolo@clalit.org.il

Locations
Israel
Clalit Health services center Recruiting
Tel Aviv, Israel, 62098
Contact: Zinger    972-5062-63652      
Principal Investigator: Zinger Joel, MD         
Sponsors and Collaborators
Meir Medical Center
Clalit Health Services
Investigators
Principal Investigator: Joel Zinger, MD clali health organization
  More Information

Publications:
Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT00684528     History of Changes
Other Study ID Numbers: jfr_il0801
Study First Received: May 21, 2008
Last Updated: March 16, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Meir Medical Center:
DM 2
Metformin
Januvia
Community setting
newly diagnosed diadetics, or diabetes patients not treated during the last year

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

ClinicalTrials.gov processed this record on October 29, 2014